July 21, 2025 • 45 mins
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On this week's episode, Dr. Hernan Bazan, M.D., co-founder and CEO at New Orleans-based South Rampart Pharma, talks about building an ultra-lean drug development company to address an unmet need observed in his own patients as a surgeon: safe treatments for acute pain. Dr. Bazan explains his strategy for building value through small raises and no full-time salaried employees, co-founding the company with his father -- a scientist and director of the Neuroscience Center of Excellence at Louisiana State University Health Sciences Center -- and why the future of pain management will likely involve multimodal approached personalized to individual patients.
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Episode Transcript
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Ben Comer (00:00):
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Welcome back to the Business ofBiotech.
(00:46):
I'm your host, Ben Comer, chiefeditor at Life Science Leader,
and today I'm speaking with Dr.
Hernan Bazan, co-founder andCEO of South Rampart Pharma, a
company developing a novelnon-opioid treatment for pain.
Hernan is a practicing vascularsurgeon at Ochsner Health and
is also the John Ochsner EndowedProfessor of Surgery and
(01:08):
Innovation.
In 2024, he was recognized bythe NIH as a Helping to End
Addiction Long-Term or HEALTrailblazer, based on the work
he's doing at South RampartPharma to address the critical
need for safer and non-addictivepain treatments in the
outpatient and inpatientpost-operative settings.
(01:28):
Hernan understands the urgentneed for safe and effective and
non-addictive therapies directlyas a surgeon and I'm excited to
learn about the developmentwork South Rampart Pharma is
doing, what challenges he'sfaced as a CEO, his approach to
lean company operations andwhat's next for the company's
(01:48):
lead candidate, SRP-001.
Thanks so much for being here,Hernan.
Dr. Hernan Bazan, M.D. (01:54):
Well, it's really a pleasure, Ben, I
was mentioning to you earlier.
I've listened to the Businessof Biotech now for, I think,
over three years and enjoy someof the true luminaries you've
had, like your CFO, Alan Shaw,and a lot of the zingers that he
shares, and the practicaladvice, as well as some of the
(02:16):
real innovative biologists thatare contributing to the biotech
and life science field that theUnited States shares and
contributes to the world.
So it's a real true pleasureand honor to be here.
Ben Comer (02:31):
Well, thank you so much for saying that.
I have to give credit to mycolleague, Matt Pillar, who
really built the podcast to whatit is today, and so I
appreciate you sticking with usthrough the change in host.
Yeah, yeah, high quality, thankyou.
Thank you so much.
I want to start, as we do onthe Business of Biotech, with a
(02:54):
little about you and yourbackground.
You are, as I mentioned in theintro, a surgeon.
Why did you decide to become asurgeon initially?
What interested you about thatfield?
Dr. Hernan Bazan, M.D. (03:09):
It's a good question in terms of, yeah,
there aren't many surgeons,true, that are doing work in
life science or biotech?
I realize Obviously there aremany physicians.
I'll tell you, when I went tomedical school, I had no idea
that I would become a surgeon.
I mean, there are certainlysome people that think of that
early on in the clinical yearsor the third and fourth years of
(03:29):
medical school, and that's whenyou really get exposed to what
it is like to be in a clinic.
And it was actually my wife,who was a classmate of mine at
Georgetown, who did the surgeryrotation first and said you may
want to consider this, and itwas basically what really
solidified it was at the veryend of the third year.
So I actually was at the NIH inBethesda where actually she and
(03:53):
I met through the Howard HughesMedical Institute as what's
called a research scholar, andit was an incredible two years.
And so when I finished thosetwo years, I thought I was going
to go into internal medicineand do some specialty like
immunology related or hematologyoncology, because I had worked
two incredible years onimmunology and HIV research.
(04:16):
And those actual years areimportant years looking back
because they really influencecritical thinking, and so if
anyone is listening, that's sortof an ascent student
investigator and trying tounderstand between clinical
medicine and research and how tomarry them.
I know probably we'll touch onthe NIH later on.
(04:38):
Those types of experiences arereal, pivotal because I spent
two years working in a lab of areal incredible person named Dr.
Ed Berger.
He only had four people in hislab then and from that work that
he did in 1996, I joined hislab in July and in May of 1996,
he published the first HIVco-receptor.
(05:02):
For about a decade people knewthat for the HIV to enter immune
cells in addition to CB4, thatthere was a second molecule that
was needed at the cell surfacefor the virus to enter.
But no one knew what thatsecond molecule was.
And Ed, with a group of fourpeople and he was competing with
very large labs around the U.
S.
and a couple around the worldwas able to discover the first
(05:25):
HIV co-receptor because he wasunder in building four in
Bethesda.
The NIH has different buildingnumbers.
Building 10 is where I wasworking when I was my first
summer there before I joined hislab.
That's the big clinical center.
Building four is right next toit.
That was part of NIAID, theInstitute of Allergy and
(05:45):
Infectious Diseases, and thehead of that at the time was
obviously Dr Tony Fauci.
And actually Dr Fauci had agroup of over 100 people and a
significant number of them werelooking for the core receptor as
well, as was a big lab at UPenn, a lab in France, a lab at NYU
and one at UCSF and others, andthen with a group of four, what
(06:07):
he did was he utilized thetechnology that was developed by
someone that he was under namedBernie Moss.
He was a National Academy ofSciences investigator and he had
cloned all the proteins,basically for vaccinia virus.
Now, why is that important?
Because with that he was ableto do these expression very
efficient expression ability ofa way of expressing proteins and
(06:29):
he set up something called afusion assay.
And the fusion assay is what Ibecame fast-outlet and that's
what he had developed as a wayto determine if the HIV alveolar
protein is in one side and CD4is on the other.
But we are going to basicallyalternate different molecules on
the cell surface to see whichone is the most efficient for
the fusion assay, and that's howwe're going to discover the
(06:50):
first and that's how we reallystarted fusing, which ended up
being a CXC chemokine, CXCR4.
And I'll tell you that thatpaper, Science, I remember
before I joined the lab I wasreading it in the New York Times
and then, when I joined the labin July, there was all this
activity from all over the worldand a month later, in one week,
(07:19):
there were five papers inscience, two in CETL, one in
nature, one in PNAS all aboutthe second co-receptor, CCR5,
which is actually the moreomnipresent one.
And so today, why is all thisimportant?
Today there's actually atherapy, an antiretroviral
meriduric, that actually targetsCCR5 and is part of the
antiretroviral, and so all ofthese are really important for
understanding what's calledviral tropism, like which virus
(07:41):
will infect which immune cellEarly on it's CXCR4, but then
the envelope protein evolves andthen it becomes CCR5 tropic.
And it was a pivotal time tounderstand how to conduct
incredible virology immunologyexperiments and then just to
also see the pace of research.
(08:01):
What I did, my contribution,was to demonstrate something
called CCR8 to the othertelokine receptors.
So that's what I published as Iwas ending the two years, that
that was important for the HNinfection of the thymus.
And how did this all tie in tothe business of biotech?
So that was a lot ofcollaboration with, obviously,
(08:23):
his group in virology immunologywhere I was working, but also a
very good immunologist named Dr.
Phil Murphy in Building 10,also NID, but a lot of
immunology, and from that theNIH actually patented that and
then licensed it.
So I didn't know really what wasgoing on.
I was just a student but, bless, bless their heart, they
included me in that the nextseveral years I would get a $150
(08:47):
check twice a year, which washelpful as a, you know, poor
resident, you know absolutely.
So that was my first sort of uhassessment of what all of how
you know really true importantbasic science that was
translationally targeted, youknow, could be potentially
commercialized.
And now, within surgery then Iwent to, as in the clinical
(09:09):
years, there actually is aparallel because within surgery
you can make immediate impact onpatients and obviously this is
an impact but it takes a longtime, but that has always
resonated with me.
And then, obviously, withinsurgery, there's no more
immediate impact in vascularsurgery because of the way you
can affect patients and that's afield that has a lot of
(09:33):
research and tremendoustranslational potential as well.
Ben Comer (09:36):
Yeah, yeah.
So let's talk about thecircumstances that led you to
found South Rampart Pharma.
Did that come out of yourexperience as a surgeon, or what
kind of drove that idea homeabout the urgent need for a
non-opioid pain therapy?
Dr. Hernan Bazan, M.D. (09:56):
Right, so this really grew out of a
discussion with the otherco-founder, the scientific
co-founder.
It was actually my father, Dr.
Nicholas Bazan.
He's a very well-knownneuroscientist.
He's got a large group over 80people still with 12 PIs on
(10:20):
stroke and neurodegenerativediseases and the neurochemistry
of different other things likeepilepsy and Alzheimer's.
Ben Comer (10:33):
Where is?
Dr. Hernan Bazan, M.D. (10:33):
his lab.
So they're located actuallyhere in the city of New Orleans
at the LSU School of Medicineand they've been very productive
and continuously NIH-fundedsince the mid-'80s and have made
seminal contributions inneuroscience and neurochemistry.
And he had done something manyyears ago in pain, so he had a
(10:56):
little bit of experience.
Many years before that he hadsomething in ophthalmology in
San Francisco with other chairsand they took the company public
.
So he had a bit of experiencein some contexts.
And so we were speaking about,obviously, the large void in
medicine.
And there's a colleague inSpain at the University of
(11:18):
Alcalá, a medicinal chemist, andwhat we were thinking was based
on the big challenge which iswhat was available and still is
really available, which is verynarrow for pain, and one of them
being paracetamol oracetaminophen or Tylenol or
Panadol all the same moleculeand those response-related
(11:39):
issues of liver toxicity,toxicity.
So to address that, what themedicinal chemists did as we
were discussing this was make alibrary of compounds in a
rational way and there'ssomething in the middle of the
molecule that prevents the livertoxicity.
So since 1983, it's been knownthat a large amount of Tylenol
or Panadol or acetaminophen cancause liver toxicity.
(12:03):
In fact it's still the numberone cause of acute formalin
hepatic failure, really In theUS and in many parts of the
Western world, and part of thereason has been because many
people realize that it's alsopresent in other formulations,
you know cold and sickness andin other things, and so people
aren't feeling well and morethan they realize, and then, as
(12:27):
you know, there's a lot morefatty liver disease, a lot more
NASH now, and so there's somesusceptibility to that increased
dose and it's a dose response.
And so this is 1983 when it waspublished in Journal of
Biological Chemistry.
Napki is a metabolite thatcauses an injury, and so the way
this was designed, this librarywas designed, was to avoid the
(12:47):
NAPKI formation.
It's called the benzopoietin.
So the library that we formedavoids that, maintaining the
analgesic or the pain relief,and we were trying to also
circumvent the toxicities ofNSAIDs, non-steroidal.
I can tell you I have patientsthat have had shoulder injuries
and they've gone on to dialysis,and obviously we all know of
(13:09):
what the problem is with opioidsand abuse potential, and that's
what we were all trying to do,is come up with a novel
non-opioid Now, even though wewere trying to bypass liver
toxicity of acetaminophenbecause these are new chemical
entities or NCEs, the regulatorypathway has to be through an Rx
(13:29):
or therapeutic and then anover-the-counter.
Obviously it's a differentregulatory pathway, which is
actually important from adevelopment point of view
because obviously the market islarger and so that's important
in terms of attracting partnersand so on later on to take this
onward, and so that's really howit all grew and that need and
(13:51):
that was the design.
And so then what we did was wewere able to secure a margin IH
grant.
That was the PI from NINDS.
They were incredibly supportive.
It was what's called a fasttrack phase one, phase two grant
, and that allowed us to do alot of the characterization.
We had already begun doing alot of the mechanisms of action,
(14:14):
about how it works in the brainto reduce pain, how it avoids
the liver toxicity, in finerdetail because of the second
mechanism, which is to maintainhepatotype junctions, and then
did a lot of what are called theFDA, ind.
This is a new drug applicationenabling studies, and a lot of
those are standardizedgenotoxicity, animal tox studies
(14:38):
into species, a lot ofmetabolic assessment to make
sure they're not toxic, and soon.
So then you can actually openan IND and get into the clinic,
and so that's what we did withthat grant.
Then the NIH was able to, wewere able to secure a second
grant, a business grant, fromthem and then raise some diluted
funding to get us where we aretoday, which is now phase two
(14:59):
already, I mean finished a verysuccessful phase one randomized
trial.
Ben Comer (15:06):
Yeah, I want to pick up on that in just a second, but
I'm curious about your locationin New Orleans.
Do you have a specific?
I mean, your father is basedthere, his lab is based there.
Is there another connection toNew Orleans or a specific reason
why you set up shop there?
Dr. Hernan Bazan, M.D. (15:24):
Well, when we moved from Argentina
when I was young, we wereyounger and so this is where
they had a faculty position.
So that's where we were raisedand I went to all my training in
different places for collegeand then med school and then
residency and fellowship, and soactually one of my main mentors
(15:52):
from surgery came back to NewOrleans from New York where I
did my residency at Mount SinaiHospital, and so I was his
partner for three years and thenwe stayed here for several
years within here for severalyears, and that's how this grew
out.
The kids are getting a littleolder now and there are other
opportunities that are rising.
So you know, the future mayevolve.
But that's where the companyhas been headquartered, because
(16:15):
a lot of the knowledge has comefrom there, from the medical
school.
Ben Comer (16:18):
Got it, got it.
Well, let's pick back up onSRP-001.
You say you're phase two readyat this point.
What are kind of the next steps?
Are you fundraising at themoment to kind of power that
phase two trial?
Give me a sense of kind ofwhat's needed, I guess, for the
(16:38):
next step.
Sure.
Dr. Hernan Bazan, M.D. (16:39):
So I think anyone listening who's a
CEO co-founder will tell youthat every single day you're
fundraising.
Obviously there's a lot ofstrategy and operations and
management, but absolutely everyday you're trying to evolve the
technology, and to do that youneed to secure good capital in
(17:01):
an intelligent way, and so we'rewell on the way with the race.
And so we're well on the waywith the race, and so we're
(17:26):
aiming to execute the phase andnetwork with and get to know
really well a very experiencedindividual.
His name is Dr Todd Bertocci.
Todd is based in Salt Lake City.
He's a former anesthesiologistand actually ex-Air Force guy,
really reputable and veryexperienced and very experienced
(17:46):
.
And the great thing about him isthat he, for now a couple of
decades, has taken reformulated,well-known drugs that are
combined, reformulated and doingacute pain trials.
And that experience is socritical because pain is
subjective and what one istrying to do in a clinical trial
(18:08):
is to subjectify somethingthat's subjective, because your
threshold of pain may be muchhigher than mine or vice versa,
and so you always have toindividualize it to the subject
and trial.
And the reason that's importantis that you can actually reveal
what the endpoints really are,in addition to, obviously other
things you may be measuring,which is reconfirm, and safety
and pharmacokinetics, how it'sabsorbent, and so on and so
forth, confirming safety andpharmacokinetics, how it's
(18:28):
absorbing, so on and so forth.
And so we formed thatpartnership, we've done the
protocol and I feel veryconfident that the phase two
trial will be very successfulbecause of the amount of detail
that we've paid to how to enroll, how to measure the primary and
then the secondary endpoints inan acute pain situation, and so
(18:50):
on and so forth for pain writlarge.
Ben Comer (18:52):
But have you seen any studies or are you aware of any
progress in that direction forspecific types of pain that
(19:16):
would not be kind ofself-reported and subjective,
that would be more able to beobjectively observed, whether
with imaging or whatever else?
Dr. Hernan Bazan, M.D. (19:26):
Yeah, that's an important question.
So actually, in a nutshell,there is no pain biomarker.
It's something the NIH actuallyhas been very interested in and
for the previous several yearsthey've actually had specific
RFAs to try to elucidatebiomarkers, a pain biomarker
there was a very interestingpaper just a few weeks ago in
(19:47):
Nature, aging, a veryinteresting paper just a few
weeks ago in Nature Aging,taking a proteomic approach to
look at Alzheimer's biomarkers.
And so for sure one could takea similar approach of looking,
let's say, at acute pain, forexample, what our phase trial
will be, which is removing oftwo impacted or partially
(20:10):
impacted third molars or wisdomteeth, pool and do an analysis
of the blood, of the serum, andto look for what is a proteomic
signature in those subjectscompared to, say, placebo and
how are they affected, comparedto those that receive something
(20:31):
like SRP-SR1, the normaladenopya that we have, versus
placebo.
Or even just control peoplethat aren't getting any sort of
tooth pull, whistling tooth pull.
And so you know there are, eventhough none have been revealed
to date.
Perhaps there are approacheslike that that was just recently
done for Alzheimer's, thatcould be applied for temple and
that.
But you're absolutely right,pain is not all the same, so
(20:52):
that's more nociceptive pain,acute pain, neuropathic pain is
an even larger problem, aclinical problem being on
patients that have diabetes,that have diabetic neuropathy,
and that may be different thansay, chemotherapy.
It's a splatin-inducedneuropathic pain that may have
its own biomarker and so, yes,to answer your question, there's
(21:14):
no specific biomarker andlikely the different types of
pains would have the differentbiomarker signature once they
can be elucidated.
But that is an active area ofresearch.
So, in addition to if abiomarker can be elucidated,
that it would be helpful formeasuring either primary or
secondary endpoint in trials.
(21:35):
It would perhaps also behelpful for individualizing
treatment on patients Right andin whom to focus, and we'll talk
about this probably at the end.
You know, multimodality versussingle agent, especially in the
future, as new pain medicinescome on the market that work
(21:56):
differently, and then you knowwhen then to subject someone to
something that has an abusepotential, like opioids, which
are still going to be the mosteffective for treating pain,
albeit the ones with the highestadverse effect profile
effective for treating pain,albeit the ones with the highest
adverse effect profile.
So it could actually not justbe just a biomarker for
predicting outcomes of trials,but there are many ways that I
(22:16):
think it could be helpfulclinically.
Obviously, it would have to becost effective, and so right now
it's very much at its nascentform, you know pre-discovery.
But I think one day we'll getthere.
Ben Comer (22:34):
And those are ways that it could, I think, be
utilized.
Yeah, and we will come back tothe landscape for pain therapies
.
But you mentioned costeffective and I wanted to follow
up on what you were sayingabout fundraising efforts.
You started out the companywith some grants, with some
diluted funding.
You're now raising, I believe,a Series A and I think correct
me if I'm wrong targeting an $8million raise, which is a lot
(22:56):
less than a lot of the biotechcompanies that you see out there
raising funds, and I'm curiousabout how you might explain that
and your kind of approach tolean operations, and does that
feed in with this?
You know importance of a newpain therapy being cost
effective.
Dr. Hernan Bazan, M.D. (23:17):
Yeah, so it's.
You know it grabs headlineswhen you do a 30, 40, 45 million
raise, for sure, and it's good.
Our approach has been differentand the reason that it's been
different is because pretty muchall the funding that we've
raised has gone into the R&D,into technology development and
(23:39):
adding value to the venture.
And in fact this was thesubject of what you and I were
talking about earlier, beforethis, which is the recent Wall
Street Journal piece, sort ofabout our lean approach where no
one is on full salary and it'sjust fractional work by the
people that are working for thecompany, the team that we formed
(24:01):
, which is a stellar team I'llshare both our CFO, our director
of CMC chemistry, our directorof toxicology, pharmacology and
our regulatory and what we'retrying to do is move and move
forward as efficiently aspossible.
(24:21):
Now, if we raised, say, $35, $40million, we could then do a
couple of pipelines we could do.
We were talking aboutneuropathic pain.
We could do neuropathic painand that would take probably
about two and a half to threeyears, many sites and those
endpoints are importantendpoints that meet.
They're probably not going tobe as clear as, let's say, an
(24:43):
acute pain trial which canactually be executed in well
under a year, which can actuallybe executed in well under a
year, and this includes writing,locking the data, data lock,
writing it and submission to theFDA.
And so what we decided to dorather than focus on two
pipelines because we were goingto do that as well as do we have
(25:06):
an intravenous formulation todevelop an IV and an
endosuspension?
We're going to develop that aswell we decided to based on some
market feedback.
I'm just focusing on acutenociceptive pain acute pain to
demonstrate, based on how weknow it works in the brain and
the animal models that we have,that demonstrate efficacy,
demonstrate pain relief, to justdemonstrate clinical efficacy
(25:27):
with a more focused round.
And that way it didn't diluteeveryone as much and we could be
more efficient in terms of thetimeframe.
And then, obviously, with thisface-to-data, it would
potentially make this a lot moretransactable.
And so, in terms of, you know,moving the technology forward,
and so all these things areimportant, you know
(25:48):
considerations.
I think the way we'restructured in the lean way is
also, you know, moving thetechnology forward, and so all
these things are important.
You know considerations.
I think the way we'restructured in the lean way is
also, you know, a reason that wecan forego.
And why do that?
You know it's important, right?
Because one obviously part ofthe audience may be people that
are in operations and so on.
You know you hire someone fulltime, you know it's going to be
for at least a year at a prettysignificant salary, and if he or
(26:13):
she is not really producing inthree or four months, you still
got to pay them for the fullyear and you've lost a year of
work.
And so we've tried to take adifferent approach, based on
conflicts that we have and so onand so forth, and the team, the
startup team that we formed, touse this approach to really
(26:34):
just put everything into the R&Dand into value formation and
forward movement.
Ben Comer (26:41):
Yeah, and I would encourage business and biotech
listeners to look up the WallStreet Journal piece when Hernan
says that he's running a leanoperation.
That is not a buzzword.
He is paying cash.
He does not have full-timesalaried employees.
He's working on mornings andnights and weekends and is
(27:05):
actually running a leanorganization.
One thing that you didn't yetspeak to that I wanted to ask
about and I think this isimportant in the context of
opioids as the standard of carefor pain therapy and the fact
that they're very cheap,available in generic form how
does this kind of model fit intoeventually getting to a price
(27:29):
that is ultimately accessible topatients, that is, you know
insurers are going to pay for,et cetera?
Dr. Hernan Bazan, M.D. (27:36):
Yeah.
So that's been one of the bigarguments for a while that
what's available is dirt cheap.
So why is there a market?
Or should there be a market,why put funding into this?
And I think this is whereVirgin Pharmaceutical should
take a lot of credit.
So, as you may some may know,some may not they've done an
(28:02):
incredible job of pushingforward a new set of molecules
and on January 30th 2025, gotFDA approval for acute pain
treatment with a molecule that'snow called Gernomax that
targets a sodium voltage 1.8,gated channel NAV 1.8.
(28:26):
Now why is that important?
It's because what they wereable to demonstrate about how
the market responded to this isvery positive.
So their market cap changed ina very significant way, such
that within a week, it was aseveral billion dollar upswing
in their market cap of the wholecompany.
Ben Comer (28:49):
So there's a belief that this is going to get used.
Is what you're saying,absolutely?
Dr. Hernan Bazan, M.D. (28:53):
Speaking , that the market was positive
on it.
And then, when you go toDecember, when they showed some
chronic pain data that we don'tneed to get into the market, cap
also reacted in a certain way,and so these are important
contemporary readouts that thereis in fact, a market appetite
(29:16):
for it.
We all know that clinically,there's a huge void.
We all know societal, there's ahuge void.
To the question that you werejust asking, though yes, what's
available are generic andthey're cheap.
Would people pay for it?
So obviously there's a lot ofpricing model.
That goes on and so on and soforth, and so what I understand
their asset is it's a twice aday dosing, and it's $31.50 per
(29:41):
day, so there can be a premiumthat can be paid.
That then will be realized bythe investors in a way that it's
balanced so that patients canstill benefit, and so it's not a
buy logic.
It's not going to commandthousands of dollars, but it's
not too cheap either, so that Ithink that the market has
(30:01):
demonstrated that, in fact,there is an appetite for paying
a premium for something that'snew, safe and effective.
Now, regarding their asset,again, they've done a great job
with demonstrating this.
I think they've said itthemselves that this is sort of
a first pass Right, and they andothers are working on others to
improve it.
(30:22):
Our approach is a bit differentbecause they're working in the
periphery, on full nerves.
We work centrally in the brain.
We know that a radiolabeledSRP-SR1 crosses the blood on
peripheral nerves.
We work centrally in the brain.
We know that a radiolabeledS-herpes or SRO1 crosses the
blood-brain barrier.
We know where it works, in themidbrain, which is called the
PAC region, the peritoneal grayarea region, and we know that
the SRO1 and that's what we'vepublished recently.
(30:45):
We actually just this morninggot notice about a second
mechanism and epigenomics andgenomics paper that we're
revising, to be published,hopefully very soon as well, to
further elucidate the mechanismof action should translate
clinically to efficacy, becausethe way SRP-SER-01 works is
(31:13):
through production of somethingcalled AM-4-O-C, and that's
actually how acetaminophen works.
Yet because it doesn't have theliver toxicity, it's got a much
wider therapeutic index, and sowhat I can show with you, ben,
is that in the hospital, when wegave patients IV Tylenol,
post-knee scope or minilaparotomy or even a modern
(31:36):
laparotomy or hip replacement,their use of dilaudid or
morphine or fentanyl goes downtremendously.
These are opioids and so it'sactually at a high dose.
It's quite effective, and sothat's what we're trying to
achieve with SRP-0-4-1.
Ibutamil just can't be used fora long time because of liver
toxicity, even intravenously,and so we're trying to take a
(31:58):
really clinically validatedmechanism of action sexually in
the brain that besides the M4-4,we're elucidating the genomic
and epigenomic mechanisms Ithink that's important to
understand other pain pathwaysand are working to demonstrate
how this efficacy will betranslated with what we'll see
(32:20):
clinically.
Ben Comer (32:21):
Right yeah, so this is not targeting the sodium
channel in the same way thatthat vertex is geronimic.
Dr. Hernan Bazan, M.D. (32:29):
Correct and that's important because the
future of pain, ben, willprobably be multimodality, so
similar to how we treat nowhypertension, you know blood
pressure, so you know there'llbe a calcium channel blocker for
blood pressure, there's athiazide diuretic, there's a
nice inhibitor that may be usedin certain patients, a beta
(32:50):
blocker, and so there aredifferent classes that can be
added to manage hypertensionblood pressure.
For chronic pain, which thereare over 51 million Americans
that have chronic pain, theeffective treatment of chronic
pain, rather than being take oneacid or combine two that have
significant kidney and or liverinjury or put a third that has a
(33:13):
significant abuse potential,hopefully the future will be a
couple of acids that workdifferent, that are effective
and that have a pretty widetherapeutic index, that don't
have much of an adverse effectprofile, and that's how I think
we move the needle in the safertreatment of pain.
Ben Comer (33:31):
And potentially personalized to some extent
Correct.
Yeah, Hernan, you've writtenthat pain is a global juggernaut
of suffering, which I foundquite poetic and I wanted to
mention it during ourconversation, but I'll use that
as a lead in to ask the question.
South Rampart was founded in2016.
(33:55):
You're coming up on 10 years asa company.
Are you where you kind of hopedyou would be starting out in
2016?
And what could you say has beenthe biggest challenge or most
surprising challenge that you'vefaced in this?
You know, 10 years of work.
Dr. Hernan Bazan, M.D. (34:15):
Yeah, that's a good question.
So I think we're exactly whatwe envisioned.
We're now a clinical stage withrobust human data that
demonstrates that SRP is safetolerable efficacy.
We've really been able toelucidate robust
pharmacokinetics, the PK, how itgets rapidly absorbed and
distributed.
Now I've optimized the protocolfor the phase two efficacy.
(34:41):
I've established somesignificant contacts, and so the
phishing funding model thatwe've utilized has allowed us to
achieve all these significantmilestones.
And again, remember, this isfrom complete synthesis, and so
the good news is we're nottaking someone else's
intellectual property that wehave to sub-license or something
(35:02):
like that.
This is all, fortunately,things that we've developed that
have spun up from theuniversity that the founders are
in in the composition of MatterIT that obviously has been
nationalized in all keyindustries.
So I think it's where we arecoming into just over eight and
a half, soon to be nine years,and then, within 12 months,
(35:29):
months will be phase three ready.
And so you know, as you knowthese things, it's never linear.
It goes, you know, oscillatesup and down, but that's how we
view it now going forward, andyou know, regarding you, you
know you asked what the biggestchallenges have been.
Um, again, obviously anyonewill tell you that the biotech
sector funding is always up anddown.
(35:51):
So, as I mentioned earlier,constantly in a fundraising mode
, nih has been very supportive.
I had a call yesterday earlymorning.
I was in San Francisco at 6 amwith my NIH program director,
nnds, who is extremelysupportive, and you know they're
going through some challenges,some significant challenges
(36:14):
facing up to 40% cuts and, moreimportantly than that, is how
the review of new grants haschanged now a couple of times
just this past few months, abouthow they're reviewed and
through which centers andinstitutes, and so it's
unfortunately translated intosome reviews I'll just mention
(36:36):
it just not being qualityreviews because of the way
they're being handled, and Ithink they're quickly trying to
fix it.
I'm very confident in the staffthat's there.
They're high-quality staff andthey're going to get the work
done.
Confident in the staff that'sthere.
They're high quality staff andthey're going to get the work
done.
And there's a lot of very goodscientists and leaders within
the NIH and they're going to getthis done.
They're going to see throughthis, and so you know you just
(36:57):
have to be creative when youlead a company like this.
Looking at you know the Ludafrom the NIH, arpa-h is an
incredible resource as well.
And then being savvy andcommunicating just with
investors financial investors,whether the VCs or angel groups
that have a healthcareassessment but also engaging
(37:18):
already with strategic reformaand giving them, sharing with
them what you're doing, so youcan get feedback and utilize
that feedback and how you makedecisions in an efficient way.
Ben Comer (37:29):
Yeah.
Yeah.
I'm glad you mentioned that youbrought up NIH, because I think
it's not always clear to folkswho aren't working directly with
the NIH what exactly ishappening.
If you read headlines, youmight think that the NIH is just
completely ending all of itsfunding or, you know, an
enormous majority of the fundingis, like, has been halted, not
(37:52):
going out the door.
People are losing their jobsway through a kind of, you know,
period of turmoil, obviouslyunder the Trump administration,
but you're somewhat confident inA the people that are working
(38:13):
there and their capabilities and, b that their mission will
continue.
Is that correct or is thereanything?
Dr. Hernan Bazan, M.D. (38:24):
Oh, absolutely, yeah, absolutely.
I mean, you know, listen, thegovernment has always had the
right to prioritize, make theirpriorities be their priority and
emphasize it.
That's always been the case.
If you look at the history, thelast 40, 50 years, they may
just change things.
You know a dozen things fromyour years.
Just this year there are manythings being changed, but that's
always in the purview of the USgovernment.
The staff at the NIH, theleadership in the institutes,
(38:48):
the ones that are the programdirectors, I can tell you are
very good scientists, very goodat administrating and very good
at working to do things in anefficient, fair way.
I think if all of this helps toincrease the efficiency, that's
going to be a huge positive andI think it is becoming a huge
positive.
(39:08):
You know there are going to beheadlines, but I absolutely have
full confidence in theday-to-day operations and people
are going to just adjust anddeprioritize certain work and
prioritize certain new work tomeet the new priorities of the
administration.
(39:29):
But absolutely, the NIH is goingto remain pivotal, and it has
to right, because if you lookback at 80, 100 years ago, the
industry was railroad, oil andsteel and now the industry is
data, biotech and AI and listen,we're kind of losing the AI
(39:53):
race to China right now and wemay lose it Hopefully we won't
but we can't lose the biotechand life science to China and EU
, and I think everyoneunderstands that's in this field
, that the way to do that is tokeep on supporting the nih and
uh obviously, then to taketechnologies, like we're doing
and many others are doing, andthen commercialize them, and so
(40:15):
that's, I think that that addsuh obviously not only a lot of
value to the health andwell-being of of humans, but
also to to the economy and jobsand so on and so forth.
So I think all those things aregoing to be realized in a way
that, well, it's make thehopefully this system, ecosystem
(40:36):
more, even more efficient.
And you know, you just have toadjust.
Ben Comer (40:42):
Yeah, I mean.
Patience aside, I think it'sundeniable that biotech is an
economic engine.
In fact, I'm glad you made thatpoint because I know that the
EU we just published an articleon Life Science Leader about a
number of initiatives that theEU is enacting because they see
it as a strategic investment toattract biotech R&D, to
(41:05):
streamline regulations, to getdrugs and innovation to the
market faster.
It's recognized I guess is whatI'm saying by nearly everyone
that there are numerous benefitsto having a strong biopharma
ecosystem.
So I'm glad you mentioned thatwe're getting close to the end
(41:25):
of our time here.
Ernan, I did want to justclarify one thing.
Srp-001 is ready to begin phasetwo trials and I think what
you're saying is you're hopefulthat at the end of phase two
(41:46):
you'll have produced sometransactable data.
Is that ultimately the goalthat you would partner or
potentially do a deal with thecompany to move the asset into
phase three and ultimately tocommercialization?
Or is it possible that you'llpursue that yourself as South
Rampart Pharma all the waythrough to approval?
(42:09):
What's your thinking on that?
Dr. Hernan Bazan, M.D. (42:11):
Right.
Good question, ben.
Obviously there are manyoptions on the table.
As you can imagine, when you'reat that stage.
There's a lot of value inworking with a medium or large
pharma once it's phase threeready, with phase two data,
because obviously the amount notjust the capital but of
(42:32):
resources that they have to dothat Absolutely we certainly
have the context to conduct thephase three and then by then,
yes, we would have obviously afull-time operations team,
because it'd be in a differentlandscape that we'd be operating
in to execute those.
And then there are thepossibilities that certain
(42:55):
pipelines are licensed out whileothers are being developed.
So, for example, acute andchronic pain may be licensed out
, while then the companydevelops the intravenous
formulation, because that's itsown other application, and or
neuropathic pain has its own andor topical.
So there are a multitude ofpossibilities.
Obviously, then, if there's asignificant amount of capital
(43:18):
with interest, and then going topublic markets is another
option by the team at that time,that could be also considered.
So there are a multitude ofopportunities.
I think my commitment is to getthis developed as efficiently
as possible so that onceefficacy is demonstrated, safety
(43:38):
, it can be utilized tocontribute to the well-being of
patients.
Ben Comer (43:43):
Yeah, and I should also mention that you have some,
I believe, ind-enabling studieskind of in the wings behind
this initial acute painindication with SRP-001.
And so that's a potentialoption for you is to bring this
lead candidate through.
And it's acute pain after awisdom tooth extraction.
(44:04):
Is that right, correct?
Dr. Hernan Bazan, M.D. (44:06):
That's the phase two.
That's the phase two.
That's the phase two.
Right, the IND enabling aremore for the intravenous
formulation for the IV, becausethe phase two is for the oral.
So, yeah, so there are amultitude of pipelines and
possibilities that are in thefuture.
Ben Comer (44:24):
Yeah, you could potentially, you know
out-license after your phase twoand use that, you know, turn
that back around into R&D onsome of your other programs.
Potentially, for sure, for sure, excellent.
Well, it's been really apleasure speaking with you,
hernan.
Thank you so much for coming onthe show.
Dr. Hernan Bazan, M.D. (44:43):
No, I enjoyed it, ben, and listen
again.
Great job on what you're doing.
Since you've taken this over,I've learned a lot from
listening to many of thesessions that you've had, so
great job.
Keep it up, and thanks forkeeping these discussions out in
the open and clear.
Ben Comer (45:00):
Thank you so much.
I appreciate that We've beenspeaking with Dr Ernan Bazan,
co-founder and CEO of SouthRampart Pharma.
I'm Ben Comer and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts and be
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
(45:22):
lifescienceleadercom.
We'll see you next week andthanks, as always, for listening
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Welcome back to the Business ofBiotech.
(00:46):
I'm your host, Ben Comer, chiefeditor at Life Science Leader,
and today I'm speaking with Dr.
Hernan Bazan, co-founder andCEO of South Rampart Pharma, a
company developing a novelnon-opioid treatment for pain.
Hernan is a practicing vascularsurgeon at Ochsner Health and
is also the John Ochsner EndowedProfessor of Surgery and
(01:08):
Innovation.
In 2024, he was recognized bythe NIH as a Helping to End
Addiction Long-Term or HEALTrailblazer, based on the work
he's doing at South RampartPharma to address the critical
need for safer and non-addictivepain treatments in the
outpatient and inpatientpost-operative settings.
(01:28):
Hernan understands the urgentneed for safe and effective and
non-addictive therapies directlyas a surgeon and I'm excited to
learn about the developmentwork South Rampart Pharma is
doing, what challenges he'sfaced as a CEO, his approach to
lean company operations andwhat's next for the company's
(01:48):
lead candidate, SRP-001.
Thanks so much for being here,Hernan.
Dr. Hernan Bazan, M.D. (01:54):
Well, it's really a pleasure, Ben, I
was mentioning to you earlier.
I've listened to the Businessof Biotech now for, I think,
over three years and enjoy someof the true luminaries you've
had, like your CFO, Alan Shaw,and a lot of the zingers that he
shares, and the practicaladvice, as well as some of the
(02:16):
real innovative biologists thatare contributing to the biotech
and life science field that theUnited States shares and
contributes to the world.
So it's a real true pleasureand honor to be here.
Ben Comer (02:31):
Well, thank you so much for saying that.
I have to give credit to mycolleague, Matt Pillar, who
really built the podcast to whatit is today, and so I
appreciate you sticking with usthrough the change in host.
Yeah, yeah, high quality, thankyou.
Thank you so much.
I want to start, as we do onthe Business of Biotech, with a
(02:54):
little about you and yourbackground.
You are, as I mentioned in theintro, a surgeon.
Why did you decide to become asurgeon initially?
What interested you about thatfield?
Dr. Hernan Bazan, M.D. (03:09):
It's a good question in terms of, yeah,
there aren't many surgeons,true, that are doing work in
life science or biotech?
I realize Obviously there aremany physicians.
I'll tell you, when I went tomedical school, I had no idea
that I would become a surgeon.
I mean, there are certainlysome people that think of that
early on in the clinical yearsor the third and fourth years of
(03:29):
medical school, and that's whenyou really get exposed to what
it is like to be in a clinic.
And it was actually my wife,who was a classmate of mine at
Georgetown, who did the surgeryrotation first and said you may
want to consider this, and itwas basically what really
solidified it was at the veryend of the third year.
So I actually was at the NIH inBethesda where actually she and
(03:53):
I met through the Howard HughesMedical Institute as what's
called a research scholar, andit was an incredible two years.
And so when I finished thosetwo years, I thought I was going
to go into internal medicineand do some specialty like
immunology related or hematologyoncology, because I had worked
two incredible years onimmunology and HIV research.
(04:16):
And those actual years areimportant years looking back
because they really influencecritical thinking, and so if
anyone is listening, that's sortof an ascent student
investigator and trying tounderstand between clinical
medicine and research and how tomarry them.
I know probably we'll touch onthe NIH later on.
(04:38):
Those types of experiences arereal, pivotal because I spent
two years working in a lab of areal incredible person named Dr.
Ed Berger.
He only had four people in hislab then and from that work that
he did in 1996, I joined hislab in July and in May of 1996,
he published the first HIVco-receptor.
(05:02):
For about a decade people knewthat for the HIV to enter immune
cells in addition to CB4, thatthere was a second molecule that
was needed at the cell surfacefor the virus to enter.
But no one knew what thatsecond molecule was.
And Ed, with a group of fourpeople and he was competing with
very large labs around the U.
S.
and a couple around the worldwas able to discover the first
(05:25):
HIV co-receptor because he wasunder in building four in
Bethesda.
The NIH has different buildingnumbers.
Building 10 is where I wasworking when I was my first
summer there before I joined hislab.
That's the big clinical center.
Building four is right next toit.
That was part of NIAID, theInstitute of Allergy and
(05:45):
Infectious Diseases, and thehead of that at the time was
obviously Dr Tony Fauci.
And actually Dr Fauci had agroup of over 100 people and a
significant number of them werelooking for the core receptor as
well, as was a big lab at UPenn, a lab in France, a lab at NYU
and one at UCSF and others, andthen with a group of four, what
(06:07):
he did was he utilized thetechnology that was developed by
someone that he was under namedBernie Moss.
He was a National Academy ofSciences investigator and he had
cloned all the proteins,basically for vaccinia virus.
Now, why is that important?
Because with that he was ableto do these expression very
efficient expression ability ofa way of expressing proteins and
(06:29):
he set up something called afusion assay.
And the fusion assay is what Ibecame fast-outlet and that's
what he had developed as a wayto determine if the HIV alveolar
protein is in one side and CD4is on the other.
But we are going to basicallyalternate different molecules on
the cell surface to see whichone is the most efficient for
the fusion assay, and that's howwe're going to discover the
(06:50):
first and that's how we reallystarted fusing, which ended up
being a CXC chemokine, CXCR4.
And I'll tell you that thatpaper, Science, I remember
before I joined the lab I wasreading it in the New York Times
and then, when I joined the labin July, there was all this
activity from all over the worldand a month later, in one week,
(07:19):
there were five papers inscience, two in CETL, one in
nature, one in PNAS all aboutthe second co-receptor, CCR5,
which is actually the moreomnipresent one.
And so today, why is all thisimportant?
Today there's actually atherapy, an antiretroviral
meriduric, that actually targetsCCR5 and is part of the
antiretroviral, and so all ofthese are really important for
understanding what's calledviral tropism, like which virus
(07:41):
will infect which immune cellEarly on it's CXCR4, but then
the envelope protein evolves andthen it becomes CCR5 tropic.
And it was a pivotal time tounderstand how to conduct
incredible virology immunologyexperiments and then just to
also see the pace of research.
(08:01):
What I did, my contribution,was to demonstrate something
called CCR8 to the othertelokine receptors.
So that's what I published as Iwas ending the two years, that
that was important for the HNinfection of the thymus.
And how did this all tie in tothe business of biotech?
So that was a lot ofcollaboration with, obviously,
(08:23):
his group in virology immunologywhere I was working, but also a
very good immunologist named Dr.
Phil Murphy in Building 10,also NID, but a lot of
immunology, and from that theNIH actually patented that and
then licensed it.
So I didn't know really what wasgoing on.
I was just a student but, bless, bless their heart, they
included me in that the nextseveral years I would get a $150
(08:47):
check twice a year, which washelpful as a, you know, poor
resident, you know absolutely.
So that was my first sort of uhassessment of what all of how
you know really true importantbasic science that was
translationally targeted, youknow, could be potentially
commercialized.
And now, within surgery then Iwent to, as in the clinical
(09:09):
years, there actually is aparallel because within surgery
you can make immediate impact onpatients and obviously this is
an impact but it takes a longtime, but that has always
resonated with me.
And then, obviously, withinsurgery, there's no more
immediate impact in vascularsurgery because of the way you
can affect patients and that's afield that has a lot of
(09:33):
research and tremendoustranslational potential as well.
Ben Comer (09:36):
Yeah, yeah.
So let's talk about thecircumstances that led you to
found South Rampart Pharma.
Did that come out of yourexperience as a surgeon, or what
kind of drove that idea homeabout the urgent need for a
non-opioid pain therapy?
Dr. Hernan Bazan, M.D. (09:56):
Right, so this really grew out of a
discussion with the otherco-founder, the scientific
co-founder.
It was actually my father, Dr.
Nicholas Bazan.
He's a very well-knownneuroscientist.
He's got a large group over 80people still with 12 PIs on
(10:20):
stroke and neurodegenerativediseases and the neurochemistry
of different other things likeepilepsy and Alzheimer's.
Ben Comer (10:33):
Where is?
Dr. Hernan Bazan, M.D. (10:33):
his lab.
So they're located actuallyhere in the city of New Orleans
at the LSU School of Medicineand they've been very productive
and continuously NIH-fundedsince the mid-'80s and have made
seminal contributions inneuroscience and neurochemistry.
And he had done something manyyears ago in pain, so he had a
(10:56):
little bit of experience.
Many years before that he hadsomething in ophthalmology in
San Francisco with other chairsand they took the company public
.
So he had a bit of experiencein some contexts.
And so we were speaking about,obviously, the large void in
medicine.
And there's a colleague inSpain at the University of
(11:18):
Alcalá, a medicinal chemist, andwhat we were thinking was based
on the big challenge which iswhat was available and still is
really available, which is verynarrow for pain, and one of them
being paracetamol oracetaminophen or Tylenol or
Panadol all the same moleculeand those response-related
(11:39):
issues of liver toxicity,toxicity.
So to address that, what themedicinal chemists did as we
were discussing this was make alibrary of compounds in a
rational way and there'ssomething in the middle of the
molecule that prevents the livertoxicity.
So since 1983, it's been knownthat a large amount of Tylenol
or Panadol or acetaminophen cancause liver toxicity.
(12:03):
In fact it's still the numberone cause of acute formalin
hepatic failure, really In theUS and in many parts of the
Western world, and part of thereason has been because many
people realize that it's alsopresent in other formulations,
you know cold and sickness andin other things, and so people
aren't feeling well and morethan they realize, and then, as
(12:27):
you know, there's a lot morefatty liver disease, a lot more
NASH now, and so there's somesusceptibility to that increased
dose and it's a dose response.
And so this is 1983 when it waspublished in Journal of
Biological Chemistry.
Napki is a metabolite thatcauses an injury, and so the way
this was designed, this librarywas designed, was to avoid the
(12:47):
NAPKI formation.
It's called the benzopoietin.
So the library that we formedavoids that, maintaining the
analgesic or the pain relief,and we were trying to also
circumvent the toxicities ofNSAIDs, non-steroidal.
I can tell you I have patientsthat have had shoulder injuries
and they've gone on to dialysis,and obviously we all know of
(13:09):
what the problem is with opioidsand abuse potential, and that's
what we were all trying to do,is come up with a novel
non-opioid Now, even though wewere trying to bypass liver
toxicity of acetaminophenbecause these are new chemical
entities or NCEs, the regulatorypathway has to be through an Rx
(13:29):
or therapeutic and then anover-the-counter.
Obviously it's a differentregulatory pathway, which is
actually important from adevelopment point of view
because obviously the market islarger and so that's important
in terms of attracting partnersand so on later on to take this
onward, and so that's really howit all grew and that need and
(13:51):
that was the design.
And so then what we did was wewere able to secure a margin IH
grant.
That was the PI from NINDS.
They were incredibly supportive.
It was what's called a fasttrack phase one, phase two grant
, and that allowed us to do alot of the characterization.
We had already begun doing alot of the mechanisms of action,
(14:14):
about how it works in the brainto reduce pain, how it avoids
the liver toxicity, in finerdetail because of the second
mechanism, which is to maintainhepatotype junctions, and then
did a lot of what are called theFDA, ind.
This is a new drug applicationenabling studies, and a lot of
those are standardizedgenotoxicity, animal tox studies
(14:38):
into species, a lot ofmetabolic assessment to make
sure they're not toxic, and soon.
So then you can actually openan IND and get into the clinic,
and so that's what we did withthat grant.
Then the NIH was able to, wewere able to secure a second
grant, a business grant, fromthem and then raise some diluted
funding to get us where we aretoday, which is now phase two
(14:59):
already, I mean finished a verysuccessful phase one randomized
trial.
Ben Comer (15:06):
Yeah, I want to pick up on that in just a second, but
I'm curious about your locationin New Orleans.
Do you have a specific?
I mean, your father is basedthere, his lab is based there.
Is there another connection toNew Orleans or a specific reason
why you set up shop there?
Dr. Hernan Bazan, M.D. (15:24):
Well, when we moved from Argentina
when I was young, we wereyounger and so this is where
they had a faculty position.
So that's where we were raisedand I went to all my training in
different places for collegeand then med school and then
residency and fellowship, and soactually one of my main mentors
(15:52):
from surgery came back to NewOrleans from New York where I
did my residency at Mount SinaiHospital, and so I was his
partner for three years and thenwe stayed here for several
years within here for severalyears, and that's how this grew
out.
The kids are getting a littleolder now and there are other
opportunities that are rising.
So you know, the future mayevolve.
But that's where the companyhas been headquartered, because
(16:15):
a lot of the knowledge has comefrom there, from the medical
school.
Ben Comer (16:18):
Got it, got it.
Well, let's pick back up onSRP-001.
You say you're phase two readyat this point.
What are kind of the next steps?
Are you fundraising at themoment to kind of power that
phase two trial?
Give me a sense of kind ofwhat's needed, I guess, for the
(16:38):
next step.
Sure.
Dr. Hernan Bazan, M.D. (16:39):
So I think anyone listening who's a
CEO co-founder will tell youthat every single day you're
fundraising.
Obviously there's a lot ofstrategy and operations and
management, but absolutely everyday you're trying to evolve the
technology, and to do that youneed to secure good capital in
(17:01):
an intelligent way, and so we'rewell on the way with the race.
And so we're well on the waywith the race, and so we're
(17:26):
aiming to execute the phase andnetwork with and get to know
really well a very experiencedindividual.
His name is Dr Todd Bertocci.
Todd is based in Salt Lake City.
He's a former anesthesiologistand actually ex-Air Force guy,
really reputable and veryexperienced and very experienced
(17:46):
.
And the great thing about him isthat he, for now a couple of
decades, has taken reformulated,well-known drugs that are
combined, reformulated and doingacute pain trials.
And that experience is socritical because pain is
subjective and what one istrying to do in a clinical trial
(18:08):
is to subjectify somethingthat's subjective, because your
threshold of pain may be muchhigher than mine or vice versa,
and so you always have toindividualize it to the subject
and trial.
And the reason that's importantis that you can actually reveal
what the endpoints really are,in addition to, obviously other
things you may be measuring,which is reconfirm, and safety
and pharmacokinetics, how it'sabsorbent, and so on and so
forth, confirming safety andpharmacokinetics, how it's
(18:28):
absorbing, so on and so forth.
And so we formed thatpartnership, we've done the
protocol and I feel veryconfident that the phase two
trial will be very successfulbecause of the amount of detail
that we've paid to how to enroll, how to measure the primary and
then the secondary endpoints inan acute pain situation, and so
(18:50):
on and so forth for pain writlarge.
Ben Comer (18:52):
But have you seen any studies or are you aware of any
progress in that direction forspecific types of pain that
(19:16):
would not be kind ofself-reported and subjective,
that would be more able to beobjectively observed, whether
with imaging or whatever else?
Dr. Hernan Bazan, M.D. (19:26):
Yeah, that's an important question.
So actually, in a nutshell,there is no pain biomarker.
It's something the NIH actuallyhas been very interested in and
for the previous several yearsthey've actually had specific
RFAs to try to elucidatebiomarkers, a pain biomarker
there was a very interestingpaper just a few weeks ago in
(19:47):
Nature, aging, a veryinteresting paper just a few
weeks ago in Nature Aging,taking a proteomic approach to
look at Alzheimer's biomarkers.
And so for sure one could takea similar approach of looking,
let's say, at acute pain, forexample, what our phase trial
will be, which is removing oftwo impacted or partially
(20:10):
impacted third molars or wisdomteeth, pool and do an analysis
of the blood, of the serum, andto look for what is a proteomic
signature in those subjectscompared to, say, placebo and
how are they affected, comparedto those that receive something
(20:31):
like SRP-SR1, the normaladenopya that we have, versus
placebo.
Or even just control peoplethat aren't getting any sort of
tooth pull, whistling tooth pull.
And so you know there are, eventhough none have been revealed
to date.
Perhaps there are approacheslike that that was just recently
done for Alzheimer's, thatcould be applied for temple and
that.
But you're absolutely right,pain is not all the same, so
(20:52):
that's more nociceptive pain,acute pain, neuropathic pain is
an even larger problem, aclinical problem being on
patients that have diabetes,that have diabetic neuropathy,
and that may be different thansay, chemotherapy.
It's a splatin-inducedneuropathic pain that may have
its own biomarker and so, yes,to answer your question, there's
(21:14):
no specific biomarker andlikely the different types of
pains would have the differentbiomarker signature once they
can be elucidated.
But that is an active area ofresearch.
So, in addition to if abiomarker can be elucidated,
that it would be helpful formeasuring either primary or
secondary endpoint in trials.
(21:35):
It would perhaps also behelpful for individualizing
treatment on patients Right andin whom to focus, and we'll talk
about this probably at the end.
You know, multimodality versussingle agent, especially in the
future, as new pain medicinescome on the market that work
(21:56):
differently, and then you knowwhen then to subject someone to
something that has an abusepotential, like opioids, which
are still going to be the mosteffective for treating pain,
albeit the ones with the highestadverse effect profile
effective for treating pain,albeit the ones with the highest
adverse effect profile.
So it could actually not justbe just a biomarker for
predicting outcomes of trials,but there are many ways that I
(22:16):
think it could be helpfulclinically.
Obviously, it would have to becost effective, and so right now
it's very much at its nascentform, you know pre-discovery.
But I think one day we'll getthere.
Ben Comer (22:34):
And those are ways that it could, I think, be
utilized.
Yeah, and we will come back tothe landscape for pain therapies
.
But you mentioned costeffective and I wanted to follow
up on what you were sayingabout fundraising efforts.
You started out the companywith some grants, with some
diluted funding.
You're now raising, I believe,a Series A and I think correct
me if I'm wrong targeting an $8million raise, which is a lot
(22:56):
less than a lot of the biotechcompanies that you see out there
raising funds, and I'm curiousabout how you might explain that
and your kind of approach tolean operations, and does that
feed in with this?
You know importance of a newpain therapy being cost
effective.
Dr. Hernan Bazan, M.D. (23:17):
Yeah, so it's.
You know it grabs headlineswhen you do a 30, 40, 45 million
raise, for sure, and it's good.
Our approach has been differentand the reason that it's been
different is because pretty muchall the funding that we've
raised has gone into the R&D,into technology development and
(23:39):
adding value to the venture.
And in fact this was thesubject of what you and I were
talking about earlier, beforethis, which is the recent Wall
Street Journal piece, sort ofabout our lean approach where no
one is on full salary and it'sjust fractional work by the
people that are working for thecompany, the team that we formed
(24:01):
, which is a stellar team I'llshare both our CFO, our director
of CMC chemistry, our directorof toxicology, pharmacology and
our regulatory and what we'retrying to do is move and move
forward as efficiently aspossible.
(24:21):
Now, if we raised, say, $35, $40million, we could then do a
couple of pipelines we could do.
We were talking aboutneuropathic pain.
We could do neuropathic painand that would take probably
about two and a half to threeyears, many sites and those
endpoints are importantendpoints that meet.
They're probably not going tobe as clear as, let's say, an
(24:43):
acute pain trial which canactually be executed in well
under a year, which can actuallybe executed in well under a
year, and this includes writing,locking the data, data lock,
writing it and submission to theFDA.
And so what we decided to dorather than focus on two
pipelines because we were goingto do that as well as do we have
(25:06):
an intravenous formulation todevelop an IV and an
endosuspension?
We're going to develop that aswell we decided to based on some
market feedback.
I'm just focusing on acutenociceptive pain acute pain to
demonstrate, based on how weknow it works in the brain and
the animal models that we have,that demonstrate efficacy,
demonstrate pain relief, to justdemonstrate clinical efficacy
(25:27):
with a more focused round.
And that way it didn't diluteeveryone as much and we could be
more efficient in terms of thetimeframe.
And then, obviously, with thisface-to-data, it would
potentially make this a lot moretransactable.
And so, in terms of, you know,moving the technology forward,
and so all these things areimportant, you know
(25:48):
considerations.
I think the way we'restructured in the lean way is
also, you know, moving thetechnology forward, and so all
these things are important.
You know considerations.
I think the way we'restructured in the lean way is
also, you know, a reason that wecan forego.
And why do that?
You know it's important, right?
Because one obviously part ofthe audience may be people that
are in operations and so on.
You know you hire someone fulltime, you know it's going to be
for at least a year at a prettysignificant salary, and if he or
(26:13):
she is not really producing inthree or four months, you still
got to pay them for the fullyear and you've lost a year of
work.
And so we've tried to take adifferent approach, based on
conflicts that we have and so onand so forth, and the team, the
startup team that we formed, touse this approach to really
(26:34):
just put everything into the R&Dand into value formation and
forward movement.
Ben Comer (26:41):
Yeah, and I would encourage business and biotech
listeners to look up the WallStreet Journal piece when Hernan
says that he's running a leanoperation.
That is not a buzzword.
He is paying cash.
He does not have full-timesalaried employees.
He's working on mornings andnights and weekends and is
(27:05):
actually running a leanorganization.
One thing that you didn't yetspeak to that I wanted to ask
about and I think this isimportant in the context of
opioids as the standard of carefor pain therapy and the fact
that they're very cheap,available in generic form how
does this kind of model fit intoeventually getting to a price
(27:29):
that is ultimately accessible topatients, that is, you know
insurers are going to pay for,et cetera?
Dr. Hernan Bazan, M.D. (27:36):
Yeah.
So that's been one of the bigarguments for a while that
what's available is dirt cheap.
So why is there a market?
Or should there be a market,why put funding into this?
And I think this is whereVirgin Pharmaceutical should
take a lot of credit.
So, as you may some may know,some may not they've done an
(28:02):
incredible job of pushingforward a new set of molecules
and on January 30th 2025, gotFDA approval for acute pain
treatment with a molecule that'snow called Gernomax that
targets a sodium voltage 1.8,gated channel NAV 1.8.
(28:26):
Now why is that important?
It's because what they wereable to demonstrate about how
the market responded to this isvery positive.
So their market cap changed ina very significant way, such
that within a week, it was aseveral billion dollar upswing
in their market cap of the wholecompany.
Ben Comer (28:49):
So there's a belief that this is going to get used.
Is what you're saying,absolutely?
Dr. Hernan Bazan, M.D. (28:53):
Speaking , that the market was positive
on it.
And then, when you go toDecember, when they showed some
chronic pain data that we don'tneed to get into the market, cap
also reacted in a certain way,and so these are important
contemporary readouts that thereis in fact, a market appetite
(29:16):
for it.
We all know that clinically,there's a huge void.
We all know societal, there's ahuge void.
To the question that you werejust asking, though yes, what's
available are generic andthey're cheap.
Would people pay for it?
So obviously there's a lot ofpricing model.
That goes on and so on and soforth, and so what I understand
their asset is it's a twice aday dosing, and it's $31.50 per
(29:41):
day, so there can be a premiumthat can be paid.
That then will be realized bythe investors in a way that it's
balanced so that patients canstill benefit, and so it's not a
buy logic.
It's not going to commandthousands of dollars, but it's
not too cheap either, so that Ithink that the market has
(30:01):
demonstrated that, in fact,there is an appetite for paying
a premium for something that'snew, safe and effective.
Now, regarding their asset,again, they've done a great job
with demonstrating this.
I think they've said itthemselves that this is sort of
a first pass Right, and they andothers are working on others to
improve it.
(30:22):
Our approach is a bit differentbecause they're working in the
periphery, on full nerves.
We work centrally in the brain.
We know that a radiolabeledSRP-SR1 crosses the blood on
peripheral nerves.
We work centrally in the brain.
We know that a radiolabeledS-herpes or SRO1 crosses the
blood-brain barrier.
We know where it works, in themidbrain, which is called the
PAC region, the peritoneal grayarea region, and we know that
the SRO1 and that's what we'vepublished recently.
(30:45):
We actually just this morninggot notice about a second
mechanism and epigenomics andgenomics paper that we're
revising, to be published,hopefully very soon as well, to
further elucidate the mechanismof action should translate
clinically to efficacy, becausethe way SRP-SER-01 works is
(31:13):
through production of somethingcalled AM-4-O-C, and that's
actually how acetaminophen works.
Yet because it doesn't have theliver toxicity, it's got a much
wider therapeutic index, and sowhat I can show with you, ben,
is that in the hospital, when wegave patients IV Tylenol,
post-knee scope or minilaparotomy or even a modern
(31:36):
laparotomy or hip replacement,their use of dilaudid or
morphine or fentanyl goes downtremendously.
These are opioids and so it'sactually at a high dose.
It's quite effective, and sothat's what we're trying to
achieve with SRP-0-4-1.
Ibutamil just can't be used fora long time because of liver
toxicity, even intravenously,and so we're trying to take a
(31:58):
really clinically validatedmechanism of action sexually in
the brain that besides the M4-4,we're elucidating the genomic
and epigenomic mechanisms Ithink that's important to
understand other pain pathwaysand are working to demonstrate
how this efficacy will betranslated with what we'll see
(32:20):
clinically.
Ben Comer (32:21):
Right yeah, so this is not targeting the sodium
channel in the same way thatthat vertex is geronimic.
Dr. Hernan Bazan, M.D. (32:29):
Correct and that's important because the
future of pain, ben, willprobably be multimodality, so
similar to how we treat nowhypertension, you know blood
pressure, so you know there'llbe a calcium channel blocker for
blood pressure, there's athiazide diuretic, there's a
nice inhibitor that may be usedin certain patients, a beta
(32:50):
blocker, and so there aredifferent classes that can be
added to manage hypertensionblood pressure.
For chronic pain, which thereare over 51 million Americans
that have chronic pain, theeffective treatment of chronic
pain, rather than being take oneacid or combine two that have
significant kidney and or liverinjury or put a third that has a
(33:13):
significant abuse potential,hopefully the future will be a
couple of acids that workdifferent, that are effective
and that have a pretty widetherapeutic index, that don't
have much of an adverse effectprofile, and that's how I think
we move the needle in the safertreatment of pain.
Ben Comer (33:31):
And potentially personalized to some extent
Correct.
Yeah, Hernan, you've writtenthat pain is a global juggernaut
of suffering, which I foundquite poetic and I wanted to
mention it during ourconversation, but I'll use that
as a lead in to ask the question.
South Rampart was founded in2016.
(33:55):
You're coming up on 10 years asa company.
Are you where you kind of hopedyou would be starting out in
2016?
And what could you say has beenthe biggest challenge or most
surprising challenge that you'vefaced in this?
You know, 10 years of work.
Dr. Hernan Bazan, M.D. (34:15):
Yeah, that's a good question.
So I think we're exactly whatwe envisioned.
We're now a clinical stage withrobust human data that
demonstrates that SRP is safetolerable efficacy.
We've really been able toelucidate robust
pharmacokinetics, the PK, how itgets rapidly absorbed and
distributed.
Now I've optimized the protocolfor the phase two efficacy.
(34:41):
I've established somesignificant contacts, and so the
phishing funding model thatwe've utilized has allowed us to
achieve all these significantmilestones.
And again, remember, this isfrom complete synthesis, and so
the good news is we're nottaking someone else's
intellectual property that wehave to sub-license or something
(35:02):
like that.
This is all, fortunately,things that we've developed that
have spun up from theuniversity that the founders are
in in the composition of MatterIT that obviously has been
nationalized in all keyindustries.
So I think it's where we arecoming into just over eight and
a half, soon to be nine years,and then, within 12 months,
(35:29):
months will be phase three ready.
And so you know, as you knowthese things, it's never linear.
It goes, you know, oscillatesup and down, but that's how we
view it now going forward, andyou know, regarding you, you
know you asked what the biggestchallenges have been.
Um, again, obviously anyonewill tell you that the biotech
sector funding is always up anddown.
(35:51):
So, as I mentioned earlier,constantly in a fundraising mode
, nih has been very supportive.
I had a call yesterday earlymorning.
I was in San Francisco at 6 amwith my NIH program director,
nnds, who is extremelysupportive, and you know they're
going through some challenges,some significant challenges
(36:14):
facing up to 40% cuts and, moreimportantly than that, is how
the review of new grants haschanged now a couple of times
just this past few months, abouthow they're reviewed and
through which centers andinstitutes, and so it's
unfortunately translated intosome reviews I'll just mention
(36:36):
it just not being qualityreviews because of the way
they're being handled, and Ithink they're quickly trying to
fix it.
I'm very confident in the staffthat's there.
They're high-quality staff andthey're going to get the work
done.
Confident in the staff that'sthere.
They're high quality staff andthey're going to get the work
done.
And there's a lot of very goodscientists and leaders within
the NIH and they're going to getthis done.
They're going to see throughthis, and so you know you just
(36:57):
have to be creative when youlead a company like this.
Looking at you know the Ludafrom the NIH, arpa-h is an
incredible resource as well.
And then being savvy andcommunicating just with
investors financial investors,whether the VCs or angel groups
that have a healthcareassessment but also engaging
(37:18):
already with strategic reformaand giving them, sharing with
them what you're doing, so youcan get feedback and utilize
that feedback and how you makedecisions in an efficient way.
Ben Comer (37:29):
Yeah.
Yeah.
I'm glad you mentioned that youbrought up NIH, because I think
it's not always clear to folkswho aren't working directly with
the NIH what exactly ishappening.
If you read headlines, youmight think that the NIH is just
completely ending all of itsfunding or, you know, an
enormous majority of the fundingis, like, has been halted, not
(37:52):
going out the door.
People are losing their jobsway through a kind of, you know,
period of turmoil, obviouslyunder the Trump administration,
but you're somewhat confident inA the people that are working
(38:13):
there and their capabilities and, b that their mission will
continue.
Is that correct or is thereanything?
Dr. Hernan Bazan, M.D. (38:24):
Oh, absolutely, yeah, absolutely.
I mean, you know, listen, thegovernment has always had the
right to prioritize, make theirpriorities be their priority and
emphasize it.
That's always been the case.
If you look at the history, thelast 40, 50 years, they may
just change things.
You know a dozen things fromyour years.
Just this year there are manythings being changed, but that's
always in the purview of the USgovernment.
The staff at the NIH, theleadership in the institutes,
(38:48):
the ones that are the programdirectors, I can tell you are
very good scientists, very goodat administrating and very good
at working to do things in anefficient, fair way.
I think if all of this helps toincrease the efficiency, that's
going to be a huge positive andI think it is becoming a huge
positive.
(39:08):
You know there are going to beheadlines, but I absolutely have
full confidence in theday-to-day operations and people
are going to just adjust anddeprioritize certain work and
prioritize certain new work tomeet the new priorities of the
administration.
(39:29):
But absolutely, the NIH is goingto remain pivotal, and it has
to right, because if you lookback at 80, 100 years ago, the
industry was railroad, oil andsteel and now the industry is
data, biotech and AI and listen,we're kind of losing the AI
(39:53):
race to China right now and wemay lose it Hopefully we won't
but we can't lose the biotechand life science to China and EU
, and I think everyoneunderstands that's in this field
, that the way to do that is tokeep on supporting the nih and
uh obviously, then to taketechnologies, like we're doing
and many others are doing, andthen commercialize them, and so
(40:15):
that's, I think that that addsuh obviously not only a lot of
value to the health andwell-being of of humans, but
also to to the economy and jobsand so on and so forth.
So I think all those things aregoing to be realized in a way
that, well, it's make thehopefully this system, ecosystem
(40:36):
more, even more efficient.
And you know, you just have toadjust.
Ben Comer (40:42):
Yeah, I mean.
Patience aside, I think it'sundeniable that biotech is an
economic engine.
In fact, I'm glad you made thatpoint because I know that the
EU we just published an articleon Life Science Leader about a
number of initiatives that theEU is enacting because they see
it as a strategic investment toattract biotech R&D, to
(41:05):
streamline regulations, to getdrugs and innovation to the
market faster.
It's recognized I guess is whatI'm saying by nearly everyone
that there are numerous benefitsto having a strong biopharma
ecosystem.
So I'm glad you mentioned thatwe're getting close to the end
(41:25):
of our time here.
Ernan, I did want to justclarify one thing.
Srp-001 is ready to begin phasetwo trials and I think what
you're saying is you're hopefulthat at the end of phase two
(41:46):
you'll have produced sometransactable data.
Is that ultimately the goalthat you would partner or
potentially do a deal with thecompany to move the asset into
phase three and ultimately tocommercialization?
Or is it possible that you'llpursue that yourself as South
Rampart Pharma all the waythrough to approval?
(42:09):
What's your thinking on that?
Dr. Hernan Bazan, M.D. (42:11):
Right.
Good question, ben.
Obviously there are manyoptions on the table.
As you can imagine, when you'reat that stage.
There's a lot of value inworking with a medium or large
pharma once it's phase threeready, with phase two data,
because obviously the amount notjust the capital but of
(42:32):
resources that they have to dothat Absolutely we certainly
have the context to conduct thephase three and then by then,
yes, we would have obviously afull-time operations team,
because it'd be in a differentlandscape that we'd be operating
in to execute those.
And then there are thepossibilities that certain
(42:55):
pipelines are licensed out whileothers are being developed.
So, for example, acute andchronic pain may be licensed out
, while then the companydevelops the intravenous
formulation, because that's itsown other application, and or
neuropathic pain has its own andor topical.
So there are a multitude ofpossibilities.
Obviously, then, if there's asignificant amount of capital
(43:18):
with interest, and then going topublic markets is another
option by the team at that time,that could be also considered.
So there are a multitude ofopportunities.
I think my commitment is to getthis developed as efficiently
as possible so that onceefficacy is demonstrated, safety
(43:38):
, it can be utilized tocontribute to the well-being of
patients.
Ben Comer (43:43):
Yeah, and I should also mention that you have some,
I believe, ind-enabling studieskind of in the wings behind
this initial acute painindication with SRP-001.
And so that's a potentialoption for you is to bring this
lead candidate through.
And it's acute pain after awisdom tooth extraction.
(44:04):
Is that right, correct?
Dr. Hernan Bazan, M.D. (44:06):
That's the phase two.
That's the phase two.
That's the phase two.
Right, the IND enabling aremore for the intravenous
formulation for the IV, becausethe phase two is for the oral.
So, yeah, so there are amultitude of pipelines and
possibilities that are in thefuture.
Ben Comer (44:24):
Yeah, you could potentially, you know
out-license after your phase twoand use that, you know, turn
that back around into R&D onsome of your other programs.
Potentially, for sure, for sure, excellent.
Well, it's been really apleasure speaking with you,
hernan.
Thank you so much for coming onthe show.
Dr. Hernan Bazan, M.D. (44:43):
No, I enjoyed it, ben, and listen
again.
Great job on what you're doing.
Since you've taken this over,I've learned a lot from
listening to many of thesessions that you've had, so
great job.
Keep it up, and thanks forkeeping these discussions out in
the open and clear.
Ben Comer (45:00):
Thank you so much.
I appreciate that We've beenspeaking with Dr Ernan Bazan,
co-founder and CEO of SouthRampart Pharma.
I'm Ben Comer and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts and be
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
(45:22):
lifescienceleadercom.
We'll see you next week andthanks, as always, for listening
.
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