April 24, 2025 • 40 mins
“This isn’t just an incremental shift, it’s a drastically different treatment dynamic,” says Rob Barrow, CEO of MindMed. On this episode of Vanguards of Health Care, Barrow speaks with Bloomberg Intelligence analyst Jean Rivera Irizarry about how MM120, a pharmaceutically optimized form of LSD, could transform the treatment landscape for anxiety and depression. They explore MindMed’s unique no-therapy approach to psychedelic trials, the design of its pivotal Phase 3 studies, and how it’s navigating regulatory hurdles to bring this once-taboo drug class into the mainstream.
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Speaker 1 (00:17):
Welcome to another episode of the Vanguards of Healthcare podcast,
where we speak with leaders at the forefront of change
in the healthcare industry. My name is John Rivera Irizari,
and I'm a biotech analyst at Bloomberg Intelligence, the in
house research arm at Bloomberg. We're very pleased to welcome
Rob Barrow, CEO of Mindmed. Rob stepped into the CEO
(00:38):
role in twenty twenty one after initially joining the company
as Chief development Officer. Before MINEMED, he led drug development
efforts at US and I Institute, where he was instrumental
in advancing psilocybin research for major depressive disorder. So let's
just jump right in to start, Rob, Can you walk
us through your career trajectory and what ultimately led you
(00:58):
to join MINEMED.
Speaker 2 (01:00):
Thanks so much for having me on here. It's spent
about ten years in a drug development organization called Oltech
Therapeutics and working on an interesting modulating treatments and drugs
and development, and then had the opportunity in twenty eighteen
(01:20):
to join an organization and called Ysona as you mentioned,
and really was my first entry point into studying this
drug class. And when I started looking at the opportunity
and looking at the historical data in the field, it
was just really incredible the kind of clinical outcomes that
researchers were seeing back before the Controlled Substance Act. And
(01:42):
to have an opportunity to get back involved with this
research and ultimately come to my med and lead the
build out of an organization and now a late stage
development program. The kind of scale of impact we think
we can have and the opportunity to shape that is
one that you can't think of it anything better to
be doing with a drug development organization.
Speaker 1 (02:04):
Oh definitely, that's a pretty impressive chalk record already. But
for those that are less familiar with the company, can
you share a brief overview of mind Med's origin story
and how the company has evolved since its founding?
Speaker 2 (02:17):
Absolutely so. The company was founded in twenty nineteen and
ultimately was listed on Nasdaq in twenty twenty one. I
joined the organization shortly before that, as you mentioned, as
a chief development officer, to build out an R and
D organization, And we'll get into some of the research
decisions we made and why we've taken the approach we have.
(02:41):
But since the time I joined the organization and as
I moved in the role of CEO. We really evolved
the entire organization from top to bottom, including a full
turnover of our entire staff and board of directors since
I joined the company. So really a sort of second chapter,
a second iteration of the organization, and one that we're
really proud to have built out.
Speaker 3 (03:02):
Yeah, and it's been a pretty dramatic evolution.
Speaker 1 (03:04):
Right, you guys went from pre clinical experimental studies to
now being just one of the few companies with a
lead stage program and anxiety or generalized anxiety disorder. So
let's talk a little bit more about your lead program,
m M one twenty Right, you guys describe it as
a pharmaceutically optimized form of LSD. Can you explain how
this formulation differs from traditional OLICD and what that optimization entails.
Speaker 2 (03:29):
Absolutely, So we're working on MM one TWENTYT so orally
dissolving tablets using catalants z ODT technology, and so this
is a lieofalized tablet that allows for ultra rapid dissolution
in the mouth and that allows for faster absorption. Effectively,
you can think of allowing for more useful time in
(03:54):
the clinic. So when we think of target concentrations with
the psychoectric class broadly, but with LSD in particular. You know,
when we're having the sort of psychoactive psychological processing that
seems to be the mechanism of action driving to clinical
effects with these drugs, we want to maximize the timing
(04:14):
clinic that patients are in that state, have reached that
level of exposure, and so the ODT formulation allows for
pregastric absorption, so faster absorption of the drug into the bloodstream,
which then ultimately increases the amount of time that patients
spend and that therapeutic window. So that innovation we worked
(04:34):
on in parallel to our phase to development program and
ultimately landed on a formulation that appears to have some
significant advantages over other formulations that have looked at.
Speaker 1 (04:43):
Yeah, so it's not just the recreational LSD that's been repurposed, right,
The optimization seems really focused on making it a viable
control therapeutic setting kind of use this for this asset. So,
following your faith to B study, you guys transition to
that orally disintegrated time. But you mentioned for the phase
three trial what drove that decision and what are the
(05:04):
key features or benefits of this dissolving tablet formulation.
Speaker 2 (05:09):
So when we embarked on the overall development program for
amand one twenty, certainly there was a decision made that
we wanted to progress as quickly as possible into the clinic,
but at the same time we recognized that we needed
to optimize the formulation to get to a formulation that
would have some significant advantages clinically and from an overall
(05:30):
performance standpoint. There's an additional sort of more in the
weeds technical aspect of the OTTO formulation, which is the
LSD and a lot of people know LSC can be
particularly unstable, and so when we looked at a capsule formulation,
our phase two formulation, for instance, had to be refrigerated
and distributed in refrigerated condition, and so we're not only
(05:52):
able to solve for clinical advantages but also solve for
many of the stability challenges using our ODT technology and
collaboration with CATALT. So we again wanted it to optimize
the formulation and arrive at something that would have clinical
and physiochemical advantages, which we looked at a wide variety
of formulations and landed on the ODT as the most
(06:14):
attractive option move forward.
Speaker 3 (06:15):
No, it definitely seems like it'll simplify administration logistics, which
is kind of a hurdle with novel therapeutics right in
the anxiety or more in the depression space with sparvado
or sketamine. Right, And how does m M one twenty
fit into the current treatment landscape for generalized anxiety disorder
or GAD. At what stage of the treatment journey would
it be used and for what types of patients.
Speaker 2 (06:39):
Yeah, it's a bit early to know in the real world,
of course, but in our trials, you know, we've intentionally
sought a broad population of both generalized anxiety disorder and
major depressive disorder phase three studies that we're pursuing in
both indications and so while initially and typically we see
this with new entrance with the novel pharmaceutical products in psychiatry,
(07:04):
and typically it's insurance that stands in the way of
access where there's some prior authorizations required. In many instances,
patients have been on prior therapies in a lot of
cases for many years. So you know, the exact patient
segments where this will start, you know, will be dictated
not only by the label that we hopefully are able
(07:24):
to receive with an approval for FDA, but also by
insurance requirements and prior authorizations. That said, we want to
have a label ultimately that can be widely accessible and
that we can have a kind of widespread adoption and impact.
We've seen a really a worsening mental health epidemic in
(07:45):
this country and around the world, and so from day one,
our approach has been to target a label that would
allow that broader adoption, allow the kind of scale of
impact that we think is ultimately needed.
Speaker 1 (07:56):
Yeah, that would be huge, right, especially since many first
line treatments like SRIS can can take weeks to work
and still leave patients with residual symptoms like waking sexual
dysfunction to name a few. How does m M one
twenty compare with existing treatments for GAD in terms of
dosing efficacy. We touched a little bit on its safety differentiation,
(08:17):
also it's durability of response.
Speaker 2 (08:19):
So the current landscape for a generalizing the disorder is
dominated by SRIS and benzada azepines and it, as to
their eyes, are daily chronic therapypines also taken daily regularly
there's been emerging concerns around the abuse potential and misuse
(08:41):
of benzida aspens, so those have largely fallen out of
clinical favors. So really what we have are sris predominantly
to treat generalize anxiety disorder, and these are our drugs
that have been around for around thirty years. We really
know it innovation in almost two decades. That is quite
different than the treatment modality that we're pursuing, which is
(09:02):
with M one twenty bringing patients in in a monitored
clinical setting, administering a single dose, and as we saw
in our Phase two program, then driving many months of
clinical benefits. So the rapid and durable effect after just
an acute intervention is really the stark in stark contrast
to that, the current of the available standards of care,
(09:23):
and even we look at novel depressive depression therapies such
as spravado Servada requires many many clinic visits. This is
two hours the patients have to spend per treatment session,
but of the fifty six treatment sessions of the year
with spravado, so a drastically different kind of patient and
clinician burden. If we're only administering a series or only
(09:47):
a few administrations over the course of a year, compared
to either daily drugs or highly frequent RECRREC treatments with spervado.
Speaker 3 (09:56):
Yeah, and those sedation side effects as well.
Speaker 1 (09:58):
You know that requires intense monitoring in the clinic, which
kind of limits its applicability and areas that may not
have centers to administer these types of therapies. Yeah, despite
the millions of people suffering from generalized anxiety disorder like
you mentioned, we haven't really seen a true novel mechanism
of action approved in over fifteen years. What positions mine
met and M one twenty in particular to potentially address
(10:21):
this gap.
Speaker 2 (10:22):
Well, let's start with the clinical data. In our phase
two program, we put around fifty percent of patients into
remission twelve weeks after a single administration of them in
one twenty at one hundred microgram dose level. Those kind
of remission numbers are something we haven't seen with the
(10:42):
current standards of care, and also the magnitude of those
data and the quality of those data led to FAA
granting our program breakthrough Therapy designation, which recognizes its potential
as a significant improvement over the current standard of care.
That alone is something that we'll represent a remarkable leap
(11:05):
forward for the field and for patients who are suffering
from generalized anxiety disorder. When we look at the magnitude
of the need, we look at the kind of life
changing impact that these drugs can have, at least when
we listen to patients in our clinical trials. That is
something that is starkly different from the current treatment landscape.
(11:26):
It is a new approach and we think that, you know,
that's intentional, that's a good thing. This is not an
incremental fift in a sort of marginal improvement. This is
a quite different treatment dynamic, but one that's absolutely necessary
given the magnitude of the problem and the promise of
the clinical data today.
Speaker 1 (11:43):
Yeah, so it really seems like the sentiment is kind
of shifting. What do you think it's contributed to that
growing acceptance of psychedelics within medical and regulatory committees. I
know you touched on you know that in the Profound Efficacy.
Do you think there's anything else that's kind of shifting
sentiment with these types of drugs.
Speaker 2 (11:57):
Well, in many ways, it starts with the need and
with patients, and when we talked to key opinion leaders
when we talk to practicing psychiatrists and psychologists, and a
recognition that the tools that are available to help patients
are inadequate and while many many patients have benefited from them,
there's still a major unmet medical need that has been
(12:22):
has not been sought. But there's also many programs that
have sought approval for general anxiety anxiety to sort of
have run into clinical setbacks, regulatory setbacks. Psychiatry is a
difficult area where to drive a sort of meaningful clinical
benefit is quite difficult. So as the data and as
high quality data that we and others have been able
(12:45):
to generate has continued to be developed and reported, I
think there's a growing sentiment of the potential promise that
these therapies could hold. And in the face of that
incredible unfortunate need, there's a connection there where a big
need and a big leap forward coming together at the
right time, really work together to change the sentiment and
(13:09):
to try to drive a sort of embrace of a
new path.
Speaker 1 (13:12):
Yeah, it's really nice to see the shift in sentiment
and the narrative is changing from stigma to serious science
right especially with recent as you mentioned, FD breakthrough therapy
designations in the space, including for m M one twenty
and for context. How do you define classic psychedelics and
what compound fall outside of that category.
Speaker 2 (13:31):
It's a great question. It's a quite interesting one because
the conversation there has evolved and in many instances can
become quite non specific. So the term classic psychedelics generally
represents the serotonergic psychedelics, and we think of drug like LSD, psilocybin,
DMT that your primary mechanism of action is mediated through
(13:57):
serotonin and largely through the serotonin two way receptors. Now,
the conversation out of convenience in many cases has shifted
over time and in some circles includes things like MDMA ketamine.
The challenge there is that each of those drugs has
a quite different mechanism of action, and the really shared
(14:19):
feature is that they have the effect of altering perception.
That again becomes so nonspecific because almost every drug in
psychiatry alters perception. So while qualitatively different, you know, if
one were to say any drug that alters perception is
a psychedelic, we would have to include things like antipsychotics
(14:40):
and benzodaeazepines and psychostimulants, which which I think, of course,
are not part of the same category. So when we
think of classics psychedelics, and it's purest form, and it
really is a pretty small subset of the drugs that
are that are being researched, that are in development today.
But LSD and M one twenty certarlier among the classic
(15:00):
psychedelics and and themoti lys in particular, has been that
the most storied, the most studied, the sort of most
widely visitible DROG of the entire class over the last
hundred years. So one that fits squarely into that classic
psychedelic label.
Speaker 1 (15:17):
It's an important distinction, right, Things like ketamine or MDMA
as you mentioned, don't act their primary action isn't through
serotonin two A receptors the same way as classic psychedelics,
and ketamine is more of a dissociative anesthetic than more
than anything in my view. But I know that the
definitions evolving and people have their own views on what
encompasses a psychedelic, But classics psychedelics I totally agree, definitely
(15:40):
via serotonin two A receptors is their main action. But
moving to your clinical trial development, you've recently launched two
Phase three trials right Voyage and Panorama for m M
one twenty in GAD or generalized anxiety. Can you walk
us through the goals and design of each of these studies.
Speaker 2 (15:56):
These studies are building off of the Phase two results
that we reported out in twenty twenty four. Each of
the studies is intending to assess one hundred micrograms of
them in one twenty ODT versus placebo. In the first study,
in Voyage, we're enrolling one hundred patients in each arm,
(16:16):
and in the second study Voyage, it's still one hundred
patients in each of those arms, but additional fifty patients
receiving a lower dose, a fifty microgram dose of them
in one twenty, which serves as a functional control. That
there's a lot of talk about functional and blinding. The
reality that when a patient takes one hundred micrograms of LSD,
(16:37):
they clearly can perceive that they've taken something, and we
showed this in our Phase two results, and so including
a lower dose level in that second study really continues
to build out a robustness argument. We have three different
trial designs between our Phase two and three program with
different allocation ratios with different controls included in them, and
at the end of the day, we're trying to generate
(16:59):
a wide range of evidence to support the clinical activity
of mm on twenty. In each of the trials, we
give a single administration of m M one twenty. We
follow patients for twelve weeks, with a primary fcandpoint being
the twelve week change from baseline in the Hamilton Anxiety
Scale that the gold Standard Scale and Generalized anxiety disorder.
(17:22):
We then follow patients for an additional nine months, and
if they have symptoms that reach a certain threshold, they
have the opportunity to receive open label m M one twenty,
which will give us a characterization of the sort of
retreatment profile, the more real worldlike retreatment modality of the
course of a year, and so two parts. At the
(17:43):
end of the day, it's a one year study in total.
The studies are both ongoing, as you mentioned with redoubts
in twenty twenty six, that we're really excited to.
Speaker 3 (17:51):
Get to very excited to see those outcomes.
Speaker 1 (17:55):
And I really like that you guys included something to
address the functional and blinding using your same drug at
a lower dose, which I think is brilliant. Some listeners
might associate psychedelics with psychotherapy.
Speaker 3 (18:07):
Why isn't therapy included.
Speaker 1 (18:08):
In your trials and what does that mean for the
future use of m M one twenty if approved? Does
this mean patients shouldn't get therapy well taking m M
one twenty if it's approved.
Speaker 2 (18:17):
You're touching on a really important topic here, which is
and one that again I think it can be somewhat
can confused at times between what we have to do
in research and what we expect to happen and likely
it would be, you know, it would be a great
thing to happen in the real world. We quite uniquely
at the time, chose to develop our program, develop them
(18:42):
in one twenty as a standalone treatment without concurrent psychotherapy,
without things like prep and integration, these words that have
been used pretty pretty not specifically in the field over time.
We did that not because we think psychotherapy is not useful,
but in fact quite the opposite. We think psychotherapy is
(19:04):
incredibly useful and done well as an incredibly effective treatment.
And so when you have an effective treatment like psychotherapy,
you can't include two interventions in the same study and
get to a clean answer. So we made the decision
that we wanted to study him IN one twenty as
a standalone treatment. That also simplifies and clarifies the regulatory
(19:27):
discussions when you're just administering a drug and studying and
trying to get approval for a drug versus a drug
plus psychotherapy, which FDA doesn't regularly FDA it doesn't regulate
a psychotherapy or the practice of medicine. So in the
real world, as we think about the future, we certainly
hope that everyone has access to psychotherapy and you can
(19:51):
can benefit from as many treatment options as possible that
will make them better at the end of the day,
is what patient care is on all about. But in
our development programs, for the purpose of having well quick,
clean study designs and getting to well defined answers, we
(20:11):
did make the decision to study IN one twenty as
a standalone and continue to do that as we go
forward in our phase three program.
Speaker 1 (20:16):
Makes total sense and actually going with out there we
may even streamline adoption quite a bit. So you plan
to study m M one twenty in major depression as
well or MDD, when might that phase three study begin
and how did your earlier anxiety or GAD data inform
or accelerate that effort.
Speaker 2 (20:33):
Yeah, so our Phase three study in MDD Emerge is
going to be starting the first half of this year.
We're incredibly excited to get that program off the ground
as well. You know, there's there's a really important feature
in GAD and MDD, which is there about eighty percent
(20:55):
overlap in terms of both the diagnostic construct and this
symptomatology that the patients who have one disorder very very
commonly have and the vast majority of cases have the
other disorder have symptoms of the other disorder. And so
when we looked at our phase two data, in addition
to some other historical data in the literature, in our
(21:17):
phase two program, we saw a really drastic reduction and
depressive symptoms. Now these work patients would generalized anxiety disorder
are big Again based on the significant overlapped symptoms and
the comorbid MDD diagnoses that we were really encouraged by
the antidepressant kind of effects that we were observing. We
(21:38):
use those data to inform the expansion and the pursuit
of a Phase three program in major depressive disorder, which
the first of which study will again be started the
first half this year.
Speaker 3 (21:48):
Yeah, that makes sense.
Speaker 1 (21:49):
I mean they're highly coomrbid as you mentioned, and there's
so much overlap in the mechanism involving sortonein modulation as
well based on preclinical datas and then give MM twentys
m M one twenty is psychedelic properties. How are you
approaching safety monitoring? I know we touched on mitigating functional
and blinding, but any other aspects about safety And I
(22:11):
know you touched on on timelines for these data updates,
but if we could recap for our listeners, when should
they have this on their radar?
Speaker 3 (22:18):
Again?
Speaker 2 (22:18):
Yeah, So, in terms of safety monitoring from a procedural standpoint,
patients are administered the drug in our trials and are
kept under observation for a fixed period of time. And
you know this is too large part to ensure the
integrity of the blinding as well, right if patients are
(22:40):
receiving either one hundred micrograms or placebo, and they if
we allowed patients to leave as soon as they had
cleared any sort of perceptual effects, so PA see what
patients might say an hour in that they're ready to go,
and so we keep everyone for a fixed eight hours
to ensure that that blinding is maintained and everyone stays
in the clinic for a consistent amount of time. During
(23:04):
the treatment session, patients again stay under observation. There's an
FDA guidance document that it was put out a few
summers ago that describes the FDA's requirements and expectations for
monitoring patients. That someone is in the room with the
patient at all times, but in our programs that the
dosing session, monitors largely are there not doing much. I mean,
(23:26):
as at a site during our phase to study, who said,
you know, I sat in this corner of the room
and caught up on notes and read a book for
the entire day. Because the patient is largely lying on
a couch, they have eye shades on many times headphones on.
So they're there to monitor psychological safety, to obviously collect
(23:48):
a lot of data on adverse events and vital science
and things of this nature that are standard for clinical
trial conduct. There's a second individual who is monitoring patients,
either in the room or by video, and this again
allows us to really with a high degree of granularity,
document what's happening in the room, but also ensure that
(24:10):
the patient's well being and that they're supported and that
they're comfortable throughout the day. We largely are oriented to
just maintain maintaining patient comfort and safety during the treatment session.
An extension of that, as you're alluding to, is this
functional and blinding concept. So it's one worth spending a
second on because again, a lot of to do has
been made about functional and blinding inclusion of other perception
(24:33):
altering drugs. So when we look at psychiatry, right, almost
every drug in psychiatry has a clear perception altering effect.
I think that benzodiazepines, a few milligrams of xanax is
clearly discernible. Patients clearly have a sort of sedative effect
from taking a bended azepine. Added the case for the
dissociative effects of ketamine and spravado, as the case for
(24:56):
the stimulant effects of taking site psych stimulus, adderall and riddlin.
So really this is not a unique feature of research
in psychiatry, but the qualitative and the sort of profound
nature of the qualitative effects is quite distinct, and I
think that may be a reason why it's commanded the
(25:19):
spotlight of research methodology. There's been a lot more focused
on functional and blinding in our field than there has
been historically, so we go to great lengths to try
to mitigate that. We use things like central raiders who
are blinded both the treatment assignment but also a visit number.
We do include additional controls in our trials, such as
our fifty microgram dose level in the second phase three
(25:42):
study panorama. We also again maintain consistency procedurally so that
patients are staying in the clinic for the same amount
of time that the site staff are as separated as
humanly possible from being able to to hell or discern
what a patient is receiving. But we also saw that
(26:04):
in our phase two study one hundred percent of patients
who got high dose either one hundred or two hundred
micrograms of m M one twenty correctly guessed that they
were on drug. So you know, there is clearly still
a discernible effect. So across the phase two and three program,
we've used multiple different study designs, a five arm study
in phase two, a two and a three arm study
(26:25):
design in phase three, that between those three studies will
really prove out the robust as to the clinical effect,
and you know, at the end of the day. We're
trying to show that a drug consistently has a both
a clinically and statistically significant effect. We've done that in
phase two and now are certainly hopeful that we'll be
able to do that in phase three with the data
(26:45):
that we'll read out, you know, for Voyage in the
first half of twenty twenty six, and then for Panorama
and Emerge our first phase three an MDD, both of
which we'll read out the second half of twenty twenty six.
So next year should be a huge year for m
M one twenty and for mind met as an organization.
Speaker 1 (27:01):
Funny, and it's really nice again to see that you
guys are really taking this functional on blinding head on.
It's good to see a more nuanced approach than simple
placebo use. So congratulate you guys for that. So moving
to the regulatory path and commercial outlook, m M one
twenty is a Schedule one compound. What are some of
the regulatory or logistical challenges in developing a Schedule one
(27:23):
drug and how has mine meed worked through them?
Speaker 2 (27:27):
So for Schedule one can controlled substances, there are additional
administrative and regulatory hurdles that we have to go through,
and that includes everything from the supply chain. So when
we chip drug, particularly across international boundaries, there are different licenses,
import and export licenses. From a study conduct standpoint, there
(27:49):
are clinical research licenses that have to be obtained from
our clinical research sites. At the end of the day,
there's a scheduling administrative process that has to play out
even after FDA approves a drug. All of these are
well defined and encoded and regulations and the law, but
certainly additional burden that our team has been incredibly skillful
(28:12):
and efficient at navigating. I think we really stand out
in the field for how effectively our team has been
able to navigate those additional burdens and support our clinical
research sites, something we intend to continue doing as we
progress and get out and hopefully get the product approved
and out into the real world. But you know, the
reality is that we are taking drugs that have been
(28:36):
put on the shelf and have been made schedule le
controlled substances, and so holding ourselves and our research sites
and our whole supply chain to the highest possible quality
standards and making sure that we can meet every law, rule,
regulation that is out there is an additional burden placed
on any research programs sitting schedule on drugs.
Speaker 1 (28:58):
Yeah, the schedule long classification definitely adds extra layers. But
you've clearly done your homework and thought this through extensively
and have a clear path forward. So just excited to
see these data and getting an FDA review asap. So
what needs to happen for M in one twenty to
ultimately reach patients? Can you speak to your commercialization plans
(29:19):
or strategy once approved?
Speaker 2 (29:21):
You know, of course an FDA approval is a critical
milestone along the way for patient access, but beyond that,
we just recently announced we hired a new chief commercial officer,
Matt Wiley, who previously read that it ran the commercial
franchise for ziram at Jazz and Pharmaceuticals. We're investing and
(29:45):
really trying to get ahead to make sure that all
of the commercial pieces in place. I think there's a
bit of a misconception at times about the scope of
the growth and the infrastructure that is needed and is
it currently available for the delivery of these products. I mean,
for drugs that require and in treatment delivery, there is
(30:06):
a pretty expansive network of interventional psychiatry clinics, you know,
some ketamine clinics, Spervado clinic clinics that are that are
certified another Servada rems to deliver spravado chugging in the
order of thousands of clinics around the US that already
(30:26):
exists that would be likely appropriate sites of care from
them one twenty if ultimately able to get it approved.
There's additional work we're doing to document the health economics,
to engage payers, to make sure that all of the technical,
nuanced administrative processes are in place that we can allow
(30:48):
rapid and expansive access to in one twenty if ultimately
fortunate enough to have it approved and marketed. So, you know,
commercial plans that are that are in motion already a
bit premature to talk about them too concretely and too
greade of detail, but something that we're already thinking about
and trying to get ahead of. Giving the level of
(31:10):
conviction and confidence we have in the Interface Street program, Yeah.
Speaker 1 (31:14):
There's definitely an infrastructure that you can leverage to kind
of get the ground running and kind of get these
to the patients that need it most. So regarding other
companies in the psychedelic space, you know, companies like Compass
and Cybebin they're also advancing psychedelic candidates. How do you
see mine mid differentiating itself over the next few years.
Speaker 2 (31:33):
Yeah, there's you know, definitely a number of companies and
there's an absolutely massive need. So we're we're optimistic, certainly
about ourselves, but also about the field and the other
programs that are out there and the opportunity to really,
you know, build out an infrastructure that everyone will be
will be leveraging. And at the end of the day,
(31:54):
it does come down to the way that our organization
supports patients and clinicians, down to the quality of the
clinical data and how meaningful and how deep and durable
the responses are. Each of us have different approaches in
terms of the indication we're pursuing, in terms of the
delivery modality, in terms of how we think about commercialization
(32:15):
in many respects, and so we're quite excited about the
field at large, but also especially about our program the
kind of response, the kind of durability, and the kind
of clinical infrastructure and delivery framework that we ultimately hope
to develop and get out into the real world.
Speaker 1 (32:35):
Each company is carving out its own differentiated niche, but
it is really impressive how far we've come from banned
substances to legitimate FDA pathways within.
Speaker 3 (32:44):
Just a few years.
Speaker 1 (32:46):
Going back to payer strategy and patient access, assuming approval
of m M one twenty, how are you thinking about reimbursement.
I know it's early on, but what conversations have you
had with payer so far around potential pricing value access.
Speaker 2 (33:00):
Yeah, it's a bit premature to say, you know, specifically
about you know, it'll put numbers to things, but we
have had quite a bit of engagement from a wide
range of payers and policy makers in those organizations to
talk about the path to getting reimbursement for patients. Obviously,
that's a critical piece in our healthcare system, is to
(33:21):
make sure that if we have a product that does
deliver as meaningful of a clinical benefit as we've seen
so far in our clinical data, we want to make
sure patients can get access and then get it paid for,
and that the infrastructure is there and that everyone in
that process is incentivized to support that access and support
delivery of our products. So that concludes everything from working
(33:44):
on collaborations with some organizations to advisory boards and direct
engagement with many payers to uh, you know, we have
a market access and an A two of our team
that is going do an incredible work and documenting and
generating evidence so that we can, I think, continue to
build awareness not only around the potential benefit and impact
(34:05):
of them in one twenty, but also about GAD. It
has been an area that has been so overlooked for
the last several decades that in many instances you almost
think of it as a dormant condition that just needs
the spotlight shown back on it for everyone to appreciate
just how burdens some and how costly and how impactful,
(34:26):
both at an individual patient level, but also at a
systemic level, at a health economic level, GAD is and
we've done a lot of work and to continue to
have those conversations to ensure we're building to a bit
of a crescendo. Obviously, we want everyone very much aligned
when when we're getting to discussions around reimbursement and market access,
(34:47):
and we've gotten an early jump start to make sure
that we're getting as far down that road as possible.
Speaker 1 (34:53):
Great, and I imagine in Charles will be watching durability
data pretty close.
Speaker 3 (34:59):
Right.
Speaker 1 (34:59):
If you can reach long term healthcare costs, that would
be a huge game changer and looking ahead, what key
milestone should we be watching from mine MED this year
and into twenty twenty six.
Speaker 2 (35:09):
Yeah, So I think that the headline grabbing milestones that
are up coming over the next couple of years, certainly
our first readout for voyage in the first half of
twenty twenty six, and then for an emergent panorama and
the second half of twenty twenty six, and then I
think all eyes are also on that clinical progress. I
think that the field has had some challenges historically and
(35:34):
enrollment and hitting milestone something that I'm incredibly proud of
our team for always having delivered on the milestones we've
put out there and the clinical deadlines that we've set.
So I think everyone's continuing to watch for those sort
of updates to make sure that we were making that
progress and that we're on track, which we have seen
a really strong engagement across those Spase three studies to
(35:58):
date and contain need to be really encouraged by the
kind of enrollment in screening and patient throughput that we're
getting across our program. So all eyes are on getting
to the Phase three data next year and then moving
as quickly as we can from there to hopefully progress
with an application.
Speaker 1 (36:15):
No, I agree, and meeting you know, guided goals. Executing
on guidance is really tough, especially in this environment. So
keeping up to those milestones has been really impressive, and
I'm sure you guys will stay on track for first
and second half of twenty twenty six. But beyond anxiety
and major depression, are there additional indications you're considering exploring
(36:36):
with m M one twenty or other assets.
Speaker 2 (36:39):
We're certainly looking at other indications for MM one twenty.
It's you know, I think a matter of being thoughtful about,
certainly as from a clinical standpoint, making sure that we
have the data and understanding of how to be most
effective and in those research programs and in an organization,
to make sure that we are being paced in measured
(37:00):
in both our financial expenditures and what we can take
on as an organization where Laser focused on delivering JD
and MDD results next year, and as we progress will
certainly continue to expand out from there. We do have
another program in the clinic, MM four two or our
m D m A, which we're developing in autism spectrum disorder,
(37:21):
So we are we're thinking widely about the potential opportunity
of not only the classic psychedelics, but in twenty which
is an isomer and a nantimer of MDMA, which we're
again looking at an autism and thinking about other potential
indications across our pipeline. So a lot of a lot
that is going on. But given the criticality of getting
(37:46):
our face through program right, that has been our first
and second focus over the course of the last few years.
Speaker 3 (37:52):
I like this focused approach.
Speaker 1 (37:53):
I mean, even within those two main indications you're going after,
there's a massive unmet need hundreds of millions globally that
could and fit from a drug like this, multi billion
dollar opportunity, which investors obviously love, so we are really
looking forward to seeing this succeed. I really want new
therapies for psychiatry to really benefit patients personally. I'm sure
(38:14):
we all know people with anxiety or depression, so the
unmet need is massive. So I really appreciate you guys
doing the work and moving this across the finish line.
So Rob thanks again for joining us today and walking
us through everything happening at mindmed. As they mentioned, there's
clearly a major need for better treatments in psychiatric care
and it's been really interesting to hear how you're tackling
(38:35):
that challenge with MM one twenty and the broader pipeline.
We'll be following the Phase three trials closely and are
looking forward to seeing how things develop over the next year.
Hopefully we'll get a chance to check in again as
more milestones are hit, which I have no doubt they
will be hit. And with that we'll wrap up today's episode.
A big thank you again to Rob Berrow, CEO of
Mindmed for being with us. If you enjoyed this conversation,
(38:57):
don't forget to leave a review and hit the fo
Hello Bien on your favorite podcast app. That way, you
won't miss any of our upcoming discussions with leaders driving
innovation and healthcare. I'm John Rivera Rozari, and you've been
listening to the Vanguards of Health podcast by Bloomberg Intelligence.
Until next time, take care,
Welcome to another episode of the Vanguards of Healthcare podcast,
where we speak with leaders at the forefront of change
in the healthcare industry. My name is John Rivera Irizari,
and I'm a biotech analyst at Bloomberg Intelligence, the in
house research arm at Bloomberg. We're very pleased to welcome
Rob Barrow, CEO of Mindmed. Rob stepped into the CEO
(00:38):
role in twenty twenty one after initially joining the company
as Chief development Officer. Before MINEMED, he led drug development
efforts at US and I Institute, where he was instrumental
in advancing psilocybin research for major depressive disorder. So let's
just jump right in to start, Rob, Can you walk
us through your career trajectory and what ultimately led you
(00:58):
to join MINEMED.
Speaker 2 (01:00):
Thanks so much for having me on here. It's spent
about ten years in a drug development organization called Oltech
Therapeutics and working on an interesting modulating treatments and drugs
and development, and then had the opportunity in twenty eighteen
(01:20):
to join an organization and called Ysona as you mentioned,
and really was my first entry point into studying this
drug class. And when I started looking at the opportunity
and looking at the historical data in the field, it
was just really incredible the kind of clinical outcomes that
researchers were seeing back before the Controlled Substance Act. And
(01:42):
to have an opportunity to get back involved with this
research and ultimately come to my med and lead the
build out of an organization and now a late stage
development program. The kind of scale of impact we think
we can have and the opportunity to shape that is
one that you can't think of it anything better to
be doing with a drug development organization.
Speaker 1 (02:04):
Oh definitely, that's a pretty impressive chalk record already. But
for those that are less familiar with the company, can
you share a brief overview of mind Med's origin story
and how the company has evolved since its founding?
Speaker 2 (02:17):
Absolutely so. The company was founded in twenty nineteen and
ultimately was listed on Nasdaq in twenty twenty one. I
joined the organization shortly before that, as you mentioned, as
a chief development officer, to build out an R and
D organization, And we'll get into some of the research
decisions we made and why we've taken the approach we have.
(02:41):
But since the time I joined the organization and as
I moved in the role of CEO. We really evolved
the entire organization from top to bottom, including a full
turnover of our entire staff and board of directors since
I joined the company. So really a sort of second chapter,
a second iteration of the organization, and one that we're
really proud to have built out.
Speaker 3 (03:02):
Yeah, and it's been a pretty dramatic evolution.
Speaker 1 (03:04):
Right, you guys went from pre clinical experimental studies to
now being just one of the few companies with a
lead stage program and anxiety or generalized anxiety disorder. So
let's talk a little bit more about your lead program,
m M one twenty Right, you guys describe it as
a pharmaceutically optimized form of LSD. Can you explain how
this formulation differs from traditional OLICD and what that optimization entails.
Speaker 2 (03:29):
Absolutely, So we're working on MM one TWENTYT so orally
dissolving tablets using catalants z ODT technology, and so this
is a lieofalized tablet that allows for ultra rapid dissolution
in the mouth and that allows for faster absorption. Effectively,
you can think of allowing for more useful time in
(03:54):
the clinic. So when we think of target concentrations with
the psychoectric class broadly, but with LSD in particular. You know,
when we're having the sort of psychoactive psychological processing that
seems to be the mechanism of action driving to clinical
effects with these drugs, we want to maximize the timing
(04:14):
clinic that patients are in that state, have reached that
level of exposure, and so the ODT formulation allows for
pregastric absorption, so faster absorption of the drug into the bloodstream,
which then ultimately increases the amount of time that patients
spend and that therapeutic window. So that innovation we worked
(04:34):
on in parallel to our phase to development program and
ultimately landed on a formulation that appears to have some
significant advantages over other formulations that have looked at.
Speaker 1 (04:43):
Yeah, so it's not just the recreational LSD that's been repurposed, right,
The optimization seems really focused on making it a viable
control therapeutic setting kind of use this for this asset. So,
following your faith to B study, you guys transition to
that orally disintegrated time. But you mentioned for the phase
three trial what drove that decision and what are the
(05:04):
key features or benefits of this dissolving tablet formulation.
Speaker 2 (05:09):
So when we embarked on the overall development program for
amand one twenty, certainly there was a decision made that
we wanted to progress as quickly as possible into the clinic,
but at the same time we recognized that we needed
to optimize the formulation to get to a formulation that
would have some significant advantages clinically and from an overall
(05:30):
performance standpoint. There's an additional sort of more in the
weeds technical aspect of the OTTO formulation, which is the
LSD and a lot of people know LSC can be
particularly unstable, and so when we looked at a capsule formulation,
our phase two formulation, for instance, had to be refrigerated
and distributed in refrigerated condition, and so we're not only
(05:52):
able to solve for clinical advantages but also solve for
many of the stability challenges using our ODT technology and
collaboration with CATALT. So we again wanted it to optimize
the formulation and arrive at something that would have clinical
and physiochemical advantages, which we looked at a wide variety
of formulations and landed on the ODT as the most
(06:14):
attractive option move forward.
Speaker 3 (06:15):
No, it definitely seems like it'll simplify administration logistics, which
is kind of a hurdle with novel therapeutics right in
the anxiety or more in the depression space with sparvado
or sketamine. Right, And how does m M one twenty
fit into the current treatment landscape for generalized anxiety disorder
or GAD. At what stage of the treatment journey would
it be used and for what types of patients.
Speaker 2 (06:39):
Yeah, it's a bit early to know in the real world,
of course, but in our trials, you know, we've intentionally
sought a broad population of both generalized anxiety disorder and
major depressive disorder phase three studies that we're pursuing in
both indications and so while initially and typically we see
this with new entrance with the novel pharmaceutical products in psychiatry,
(07:04):
and typically it's insurance that stands in the way of
access where there's some prior authorizations required. In many instances,
patients have been on prior therapies in a lot of
cases for many years. So you know, the exact patient
segments where this will start, you know, will be dictated
not only by the label that we hopefully are able
(07:24):
to receive with an approval for FDA, but also by
insurance requirements and prior authorizations. That said, we want to
have a label ultimately that can be widely accessible and
that we can have a kind of widespread adoption and impact.
We've seen a really a worsening mental health epidemic in
(07:45):
this country and around the world, and so from day one,
our approach has been to target a label that would
allow that broader adoption, allow the kind of scale of
impact that we think is ultimately needed.
Speaker 1 (07:56):
Yeah, that would be huge, right, especially since many first
line treatments like SRIS can can take weeks to work
and still leave patients with residual symptoms like waking sexual
dysfunction to name a few. How does m M one
twenty compare with existing treatments for GAD in terms of
dosing efficacy. We touched a little bit on its safety differentiation,
(08:17):
also it's durability of response.
Speaker 2 (08:19):
So the current landscape for a generalizing the disorder is
dominated by SRIS and benzada azepines and it, as to
their eyes, are daily chronic therapypines also taken daily regularly
there's been emerging concerns around the abuse potential and misuse
(08:41):
of benzida aspens, so those have largely fallen out of
clinical favors. So really what we have are sris predominantly
to treat generalize anxiety disorder, and these are our drugs
that have been around for around thirty years. We really
know it innovation in almost two decades. That is quite
different than the treatment modality that we're pursuing, which is
(09:02):
with M one twenty bringing patients in in a monitored
clinical setting, administering a single dose, and as we saw
in our Phase two program, then driving many months of
clinical benefits. So the rapid and durable effect after just
an acute intervention is really the stark in stark contrast
to that, the current of the available standards of care,
(09:23):
and even we look at novel depressive depression therapies such
as spravado Servada requires many many clinic visits. This is
two hours the patients have to spend per treatment session,
but of the fifty six treatment sessions of the year
with spravado, so a drastically different kind of patient and
clinician burden. If we're only administering a series or only
(09:47):
a few administrations over the course of a year, compared
to either daily drugs or highly frequent RECRREC treatments with spervado.
Speaker 3 (09:56):
Yeah, and those sedation side effects as well.
Speaker 1 (09:58):
You know that requires intense monitoring in the clinic, which
kind of limits its applicability and areas that may not
have centers to administer these types of therapies. Yeah, despite
the millions of people suffering from generalized anxiety disorder like
you mentioned, we haven't really seen a true novel mechanism
of action approved in over fifteen years. What positions mine
met and M one twenty in particular to potentially address
(10:21):
this gap.
Speaker 2 (10:22):
Well, let's start with the clinical data. In our phase
two program, we put around fifty percent of patients into
remission twelve weeks after a single administration of them in
one twenty at one hundred microgram dose level. Those kind
of remission numbers are something we haven't seen with the
(10:42):
current standards of care, and also the magnitude of those
data and the quality of those data led to FAA
granting our program breakthrough Therapy designation, which recognizes its potential
as a significant improvement over the current standard of care.
That alone is something that we'll represent a remarkable leap
(11:05):
forward for the field and for patients who are suffering
from generalized anxiety disorder. When we look at the magnitude
of the need, we look at the kind of life
changing impact that these drugs can have, at least when
we listen to patients in our clinical trials. That is
something that is starkly different from the current treatment landscape.
(11:26):
It is a new approach and we think that, you know,
that's intentional, that's a good thing. This is not an
incremental fift in a sort of marginal improvement. This is
a quite different treatment dynamic, but one that's absolutely necessary
given the magnitude of the problem and the promise of
the clinical data today.
Speaker 1 (11:43):
Yeah, so it really seems like the sentiment is kind
of shifting. What do you think it's contributed to that
growing acceptance of psychedelics within medical and regulatory committees. I
know you touched on you know that in the Profound Efficacy.
Do you think there's anything else that's kind of shifting
sentiment with these types of drugs.
Speaker 2 (11:57):
Well, in many ways, it starts with the need and
with patients, and when we talked to key opinion leaders
when we talk to practicing psychiatrists and psychologists, and a
recognition that the tools that are available to help patients
are inadequate and while many many patients have benefited from them,
there's still a major unmet medical need that has been
(12:22):
has not been sought. But there's also many programs that
have sought approval for general anxiety anxiety to sort of
have run into clinical setbacks, regulatory setbacks. Psychiatry is a
difficult area where to drive a sort of meaningful clinical
benefit is quite difficult. So as the data and as
high quality data that we and others have been able
(12:45):
to generate has continued to be developed and reported, I
think there's a growing sentiment of the potential promise that
these therapies could hold. And in the face of that
incredible unfortunate need, there's a connection there where a big
need and a big leap forward coming together at the
right time, really work together to change the sentiment and
(13:09):
to try to drive a sort of embrace of a
new path.
Speaker 1 (13:12):
Yeah, it's really nice to see the shift in sentiment
and the narrative is changing from stigma to serious science
right especially with recent as you mentioned, FD breakthrough therapy
designations in the space, including for m M one twenty
and for context. How do you define classic psychedelics and
what compound fall outside of that category.
Speaker 2 (13:31):
It's a great question. It's a quite interesting one because
the conversation there has evolved and in many instances can
become quite non specific. So the term classic psychedelics generally
represents the serotonergic psychedelics, and we think of drug like LSD, psilocybin,
DMT that your primary mechanism of action is mediated through
(13:57):
serotonin and largely through the serotonin two way receptors. Now,
the conversation out of convenience in many cases has shifted
over time and in some circles includes things like MDMA ketamine.
The challenge there is that each of those drugs has
a quite different mechanism of action, and the really shared
(14:19):
feature is that they have the effect of altering perception.
That again becomes so nonspecific because almost every drug in
psychiatry alters perception. So while qualitatively different, you know, if
one were to say any drug that alters perception is
a psychedelic, we would have to include things like antipsychotics
(14:40):
and benzodaeazepines and psychostimulants, which which I think, of course,
are not part of the same category. So when we
think of classics psychedelics, and it's purest form, and it
really is a pretty small subset of the drugs that
are that are being researched, that are in development today.
But LSD and M one twenty certarlier among the classic
(15:00):
psychedelics and and themoti lys in particular, has been that
the most storied, the most studied, the sort of most
widely visitible DROG of the entire class over the last
hundred years. So one that fits squarely into that classic
psychedelic label.
Speaker 1 (15:17):
It's an important distinction, right, Things like ketamine or MDMA
as you mentioned, don't act their primary action isn't through
serotonin two A receptors the same way as classic psychedelics,
and ketamine is more of a dissociative anesthetic than more
than anything in my view. But I know that the
definitions evolving and people have their own views on what
encompasses a psychedelic, But classics psychedelics I totally agree, definitely
(15:40):
via serotonin two A receptors is their main action. But
moving to your clinical trial development, you've recently launched two
Phase three trials right Voyage and Panorama for m M
one twenty in GAD or generalized anxiety. Can you walk
us through the goals and design of each of these studies.
Speaker 2 (15:56):
These studies are building off of the Phase two results
that we reported out in twenty twenty four. Each of
the studies is intending to assess one hundred micrograms of
them in one twenty ODT versus placebo. In the first study,
in Voyage, we're enrolling one hundred patients in each arm,
(16:16):
and in the second study Voyage, it's still one hundred
patients in each of those arms, but additional fifty patients
receiving a lower dose, a fifty microgram dose of them
in one twenty, which serves as a functional control. That
there's a lot of talk about functional and blinding. The
reality that when a patient takes one hundred micrograms of LSD,
(16:37):
they clearly can perceive that they've taken something, and we
showed this in our Phase two results, and so including
a lower dose level in that second study really continues
to build out a robustness argument. We have three different
trial designs between our Phase two and three program with
different allocation ratios with different controls included in them, and
at the end of the day, we're trying to generate
(16:59):
a wide range of evidence to support the clinical activity
of mm on twenty. In each of the trials, we
give a single administration of m M one twenty. We
follow patients for twelve weeks, with a primary fcandpoint being
the twelve week change from baseline in the Hamilton Anxiety
Scale that the gold Standard Scale and Generalized anxiety disorder.
(17:22):
We then follow patients for an additional nine months, and
if they have symptoms that reach a certain threshold, they
have the opportunity to receive open label m M one twenty,
which will give us a characterization of the sort of
retreatment profile, the more real worldlike retreatment modality of the
course of a year, and so two parts. At the
(17:43):
end of the day, it's a one year study in total.
The studies are both ongoing, as you mentioned with redoubts
in twenty twenty six, that we're really excited to.
Speaker 3 (17:51):
Get to very excited to see those outcomes.
Speaker 1 (17:55):
And I really like that you guys included something to
address the functional and blinding using your same drug at
a lower dose, which I think is brilliant. Some listeners
might associate psychedelics with psychotherapy.
Speaker 3 (18:07):
Why isn't therapy included.
Speaker 1 (18:08):
In your trials and what does that mean for the
future use of m M one twenty if approved? Does
this mean patients shouldn't get therapy well taking m M
one twenty if it's approved.
Speaker 2 (18:17):
You're touching on a really important topic here, which is
and one that again I think it can be somewhat
can confused at times between what we have to do
in research and what we expect to happen and likely
it would be, you know, it would be a great
thing to happen in the real world. We quite uniquely
at the time, chose to develop our program, develop them
(18:42):
in one twenty as a standalone treatment without concurrent psychotherapy,
without things like prep and integration, these words that have
been used pretty pretty not specifically in the field over time.
We did that not because we think psychotherapy is not useful,
but in fact quite the opposite. We think psychotherapy is
(19:04):
incredibly useful and done well as an incredibly effective treatment.
And so when you have an effective treatment like psychotherapy,
you can't include two interventions in the same study and
get to a clean answer. So we made the decision
that we wanted to study him IN one twenty as
a standalone treatment. That also simplifies and clarifies the regulatory
(19:27):
discussions when you're just administering a drug and studying and
trying to get approval for a drug versus a drug
plus psychotherapy, which FDA doesn't regularly FDA it doesn't regulate
a psychotherapy or the practice of medicine. So in the
real world, as we think about the future, we certainly
hope that everyone has access to psychotherapy and you can
(19:51):
can benefit from as many treatment options as possible that
will make them better at the end of the day,
is what patient care is on all about. But in
our development programs, for the purpose of having well quick,
clean study designs and getting to well defined answers, we
(20:11):
did make the decision to study IN one twenty as
a standalone and continue to do that as we go
forward in our phase three program.
Speaker 1 (20:16):
Makes total sense and actually going with out there we
may even streamline adoption quite a bit. So you plan
to study m M one twenty in major depression as
well or MDD, when might that phase three study begin
and how did your earlier anxiety or GAD data inform
or accelerate that effort.
Speaker 2 (20:33):
Yeah, so our Phase three study in MDD Emerge is
going to be starting the first half of this year.
We're incredibly excited to get that program off the ground
as well. You know, there's there's a really important feature
in GAD and MDD, which is there about eighty percent
(20:55):
overlap in terms of both the diagnostic construct and this
symptomatology that the patients who have one disorder very very
commonly have and the vast majority of cases have the
other disorder have symptoms of the other disorder. And so
when we looked at our phase two data, in addition
to some other historical data in the literature, in our
(21:17):
phase two program, we saw a really drastic reduction and
depressive symptoms. Now these work patients would generalized anxiety disorder
are big Again based on the significant overlapped symptoms and
the comorbid MDD diagnoses that we were really encouraged by
the antidepressant kind of effects that we were observing. We
(21:38):
use those data to inform the expansion and the pursuit
of a Phase three program in major depressive disorder, which
the first of which study will again be started the
first half this year.
Speaker 3 (21:48):
Yeah, that makes sense.
Speaker 1 (21:49):
I mean they're highly coomrbid as you mentioned, and there's
so much overlap in the mechanism involving sortonein modulation as
well based on preclinical datas and then give MM twentys
m M one twenty is psychedelic properties. How are you
approaching safety monitoring? I know we touched on mitigating functional
and blinding, but any other aspects about safety And I
(22:11):
know you touched on on timelines for these data updates,
but if we could recap for our listeners, when should
they have this on their radar?
Speaker 3 (22:18):
Again?
Speaker 2 (22:18):
Yeah, So, in terms of safety monitoring from a procedural standpoint,
patients are administered the drug in our trials and are
kept under observation for a fixed period of time. And
you know this is too large part to ensure the
integrity of the blinding as well, right if patients are
(22:40):
receiving either one hundred micrograms or placebo, and they if
we allowed patients to leave as soon as they had
cleared any sort of perceptual effects, so PA see what
patients might say an hour in that they're ready to go,
and so we keep everyone for a fixed eight hours
to ensure that that blinding is maintained and everyone stays
in the clinic for a consistent amount of time. During
(23:04):
the treatment session, patients again stay under observation. There's an
FDA guidance document that it was put out a few
summers ago that describes the FDA's requirements and expectations for
monitoring patients. That someone is in the room with the
patient at all times, but in our programs that the
dosing session, monitors largely are there not doing much. I mean,
(23:26):
as at a site during our phase to study, who said,
you know, I sat in this corner of the room
and caught up on notes and read a book for
the entire day. Because the patient is largely lying on
a couch, they have eye shades on many times headphones on.
So they're there to monitor psychological safety, to obviously collect
(23:48):
a lot of data on adverse events and vital science
and things of this nature that are standard for clinical
trial conduct. There's a second individual who is monitoring patients,
either in the room or by video, and this again
allows us to really with a high degree of granularity,
document what's happening in the room, but also ensure that
(24:10):
the patient's well being and that they're supported and that
they're comfortable throughout the day. We largely are oriented to
just maintain maintaining patient comfort and safety during the treatment session.
An extension of that, as you're alluding to, is this
functional and blinding concept. So it's one worth spending a
second on because again, a lot of to do has
been made about functional and blinding inclusion of other perception
(24:33):
altering drugs. So when we look at psychiatry, right, almost
every drug in psychiatry has a clear perception altering effect.
I think that benzodiazepines, a few milligrams of xanax is
clearly discernible. Patients clearly have a sort of sedative effect
from taking a bended azepine. Added the case for the
dissociative effects of ketamine and spravado, as the case for
(24:56):
the stimulant effects of taking site psych stimulus, adderall and riddlin.
So really this is not a unique feature of research
in psychiatry, but the qualitative and the sort of profound
nature of the qualitative effects is quite distinct, and I
think that may be a reason why it's commanded the
(25:19):
spotlight of research methodology. There's been a lot more focused
on functional and blinding in our field than there has
been historically, so we go to great lengths to try
to mitigate that. We use things like central raiders who
are blinded both the treatment assignment but also a visit number.
We do include additional controls in our trials, such as
our fifty microgram dose level in the second phase three
(25:42):
study panorama. We also again maintain consistency procedurally so that
patients are staying in the clinic for the same amount
of time that the site staff are as separated as
humanly possible from being able to to hell or discern
what a patient is receiving. But we also saw that
(26:04):
in our phase two study one hundred percent of patients
who got high dose either one hundred or two hundred
micrograms of m M one twenty correctly guessed that they
were on drug. So you know, there is clearly still
a discernible effect. So across the phase two and three program,
we've used multiple different study designs, a five arm study
in phase two, a two and a three arm study
(26:25):
design in phase three, that between those three studies will
really prove out the robust as to the clinical effect,
and you know, at the end of the day. We're
trying to show that a drug consistently has a both
a clinically and statistically significant effect. We've done that in
phase two and now are certainly hopeful that we'll be
able to do that in phase three with the data
(26:45):
that we'll read out, you know, for Voyage in the
first half of twenty twenty six, and then for Panorama
and Emerge our first phase three an MDD, both of
which we'll read out the second half of twenty twenty six.
So next year should be a huge year for m
M one twenty and for mind met as an organization.
Speaker 1 (27:01):
Funny, and it's really nice again to see that you
guys are really taking this functional on blinding head on.
It's good to see a more nuanced approach than simple
placebo use. So congratulate you guys for that. So moving
to the regulatory path and commercial outlook, m M one
twenty is a Schedule one compound. What are some of
the regulatory or logistical challenges in developing a Schedule one
(27:23):
drug and how has mine meed worked through them?
Speaker 2 (27:27):
So for Schedule one can controlled substances, there are additional
administrative and regulatory hurdles that we have to go through,
and that includes everything from the supply chain. So when
we chip drug, particularly across international boundaries, there are different licenses,
import and export licenses. From a study conduct standpoint, there
(27:49):
are clinical research licenses that have to be obtained from
our clinical research sites. At the end of the day,
there's a scheduling administrative process that has to play out
even after FDA approves a drug. All of these are
well defined and encoded and regulations and the law, but
certainly additional burden that our team has been incredibly skillful
(28:12):
and efficient at navigating. I think we really stand out
in the field for how effectively our team has been
able to navigate those additional burdens and support our clinical
research sites, something we intend to continue doing as we
progress and get out and hopefully get the product approved
and out into the real world. But you know, the
reality is that we are taking drugs that have been
(28:36):
put on the shelf and have been made schedule le
controlled substances, and so holding ourselves and our research sites
and our whole supply chain to the highest possible quality
standards and making sure that we can meet every law, rule,
regulation that is out there is an additional burden placed
on any research programs sitting schedule on drugs.
Speaker 1 (28:58):
Yeah, the schedule long classification definitely adds extra layers. But
you've clearly done your homework and thought this through extensively
and have a clear path forward. So just excited to
see these data and getting an FDA review asap. So
what needs to happen for M in one twenty to
ultimately reach patients? Can you speak to your commercialization plans
(29:19):
or strategy once approved?
Speaker 2 (29:21):
You know, of course an FDA approval is a critical
milestone along the way for patient access, but beyond that,
we just recently announced we hired a new chief commercial officer,
Matt Wiley, who previously read that it ran the commercial
franchise for ziram at Jazz and Pharmaceuticals. We're investing and
(29:45):
really trying to get ahead to make sure that all
of the commercial pieces in place. I think there's a
bit of a misconception at times about the scope of
the growth and the infrastructure that is needed and is
it currently available for the delivery of these products. I mean,
for drugs that require and in treatment delivery, there is
(30:06):
a pretty expansive network of interventional psychiatry clinics, you know,
some ketamine clinics, Spervado clinic clinics that are that are
certified another Servada rems to deliver spravado chugging in the
order of thousands of clinics around the US that already
(30:26):
exists that would be likely appropriate sites of care from
them one twenty if ultimately able to get it approved.
There's additional work we're doing to document the health economics,
to engage payers, to make sure that all of the technical,
nuanced administrative processes are in place that we can allow
(30:48):
rapid and expansive access to in one twenty if ultimately
fortunate enough to have it approved and marketed. So, you know,
commercial plans that are that are in motion already a
bit premature to talk about them too concretely and too
greade of detail, but something that we're already thinking about
and trying to get ahead of. Giving the level of
(31:10):
conviction and confidence we have in the Interface Street program, Yeah.
Speaker 1 (31:14):
There's definitely an infrastructure that you can leverage to kind
of get the ground running and kind of get these
to the patients that need it most. So regarding other
companies in the psychedelic space, you know, companies like Compass
and Cybebin they're also advancing psychedelic candidates. How do you
see mine mid differentiating itself over the next few years.
Speaker 2 (31:33):
Yeah, there's you know, definitely a number of companies and
there's an absolutely massive need. So we're we're optimistic, certainly
about ourselves, but also about the field and the other
programs that are out there and the opportunity to really,
you know, build out an infrastructure that everyone will be
will be leveraging. And at the end of the day,
(31:54):
it does come down to the way that our organization
supports patients and clinicians, down to the quality of the
clinical data and how meaningful and how deep and durable
the responses are. Each of us have different approaches in
terms of the indication we're pursuing, in terms of the
delivery modality, in terms of how we think about commercialization
(32:15):
in many respects, and so we're quite excited about the
field at large, but also especially about our program the
kind of response, the kind of durability, and the kind
of clinical infrastructure and delivery framework that we ultimately hope
to develop and get out into the real world.
Speaker 1 (32:35):
Each company is carving out its own differentiated niche, but
it is really impressive how far we've come from banned
substances to legitimate FDA pathways within.
Speaker 3 (32:44):
Just a few years.
Speaker 1 (32:46):
Going back to payer strategy and patient access, assuming approval
of m M one twenty, how are you thinking about reimbursement.
I know it's early on, but what conversations have you
had with payer so far around potential pricing value access.
Speaker 2 (33:00):
Yeah, it's a bit premature to say, you know, specifically
about you know, it'll put numbers to things, but we
have had quite a bit of engagement from a wide
range of payers and policy makers in those organizations to
talk about the path to getting reimbursement for patients. Obviously,
that's a critical piece in our healthcare system, is to
(33:21):
make sure that if we have a product that does
deliver as meaningful of a clinical benefit as we've seen
so far in our clinical data, we want to make
sure patients can get access and then get it paid for,
and that the infrastructure is there and that everyone in
that process is incentivized to support that access and support
delivery of our products. So that concludes everything from working
(33:44):
on collaborations with some organizations to advisory boards and direct
engagement with many payers to uh, you know, we have
a market access and an A two of our team
that is going do an incredible work and documenting and
generating evidence so that we can, I think, continue to
build awareness not only around the potential benefit and impact
(34:05):
of them in one twenty, but also about GAD. It
has been an area that has been so overlooked for
the last several decades that in many instances you almost
think of it as a dormant condition that just needs
the spotlight shown back on it for everyone to appreciate
just how burdens some and how costly and how impactful,
(34:26):
both at an individual patient level, but also at a
systemic level, at a health economic level, GAD is and
we've done a lot of work and to continue to
have those conversations to ensure we're building to a bit
of a crescendo. Obviously, we want everyone very much aligned
when when we're getting to discussions around reimbursement and market access,
(34:47):
and we've gotten an early jump start to make sure
that we're getting as far down that road as possible.
Speaker 1 (34:53):
Great, and I imagine in Charles will be watching durability
data pretty close.
Speaker 3 (34:59):
Right.
Speaker 1 (34:59):
If you can reach long term healthcare costs, that would
be a huge game changer and looking ahead, what key
milestone should we be watching from mine MED this year
and into twenty twenty six.
Speaker 2 (35:09):
Yeah, So I think that the headline grabbing milestones that
are up coming over the next couple of years, certainly
our first readout for voyage in the first half of
twenty twenty six, and then for an emergent panorama and
the second half of twenty twenty six, and then I
think all eyes are also on that clinical progress. I
think that the field has had some challenges historically and
(35:34):
enrollment and hitting milestone something that I'm incredibly proud of
our team for always having delivered on the milestones we've
put out there and the clinical deadlines that we've set.
So I think everyone's continuing to watch for those sort
of updates to make sure that we were making that
progress and that we're on track, which we have seen
a really strong engagement across those Spase three studies to
(35:58):
date and contain need to be really encouraged by the
kind of enrollment in screening and patient throughput that we're
getting across our program. So all eyes are on getting
to the Phase three data next year and then moving
as quickly as we can from there to hopefully progress
with an application.
Speaker 1 (36:15):
No, I agree, and meeting you know, guided goals. Executing
on guidance is really tough, especially in this environment. So
keeping up to those milestones has been really impressive, and
I'm sure you guys will stay on track for first
and second half of twenty twenty six. But beyond anxiety
and major depression, are there additional indications you're considering exploring
(36:36):
with m M one twenty or other assets.
Speaker 2 (36:39):
We're certainly looking at other indications for MM one twenty.
It's you know, I think a matter of being thoughtful about,
certainly as from a clinical standpoint, making sure that we
have the data and understanding of how to be most
effective and in those research programs and in an organization,
to make sure that we are being paced in measured
(37:00):
in both our financial expenditures and what we can take
on as an organization where Laser focused on delivering JD
and MDD results next year, and as we progress will
certainly continue to expand out from there. We do have
another program in the clinic, MM four two or our
m D m A, which we're developing in autism spectrum disorder,
(37:21):
So we are we're thinking widely about the potential opportunity
of not only the classic psychedelics, but in twenty which
is an isomer and a nantimer of MDMA, which we're
again looking at an autism and thinking about other potential
indications across our pipeline. So a lot of a lot
that is going on. But given the criticality of getting
(37:46):
our face through program right, that has been our first
and second focus over the course of the last few years.
Speaker 3 (37:52):
I like this focused approach.
Speaker 1 (37:53):
I mean, even within those two main indications you're going after,
there's a massive unmet need hundreds of millions globally that
could and fit from a drug like this, multi billion
dollar opportunity, which investors obviously love, so we are really
looking forward to seeing this succeed. I really want new
therapies for psychiatry to really benefit patients personally. I'm sure
(38:14):
we all know people with anxiety or depression, so the
unmet need is massive. So I really appreciate you guys
doing the work and moving this across the finish line.
So Rob thanks again for joining us today and walking
us through everything happening at mindmed. As they mentioned, there's
clearly a major need for better treatments in psychiatric care
and it's been really interesting to hear how you're tackling
(38:35):
that challenge with MM one twenty and the broader pipeline.
We'll be following the Phase three trials closely and are
looking forward to seeing how things develop over the next year.
Hopefully we'll get a chance to check in again as
more milestones are hit, which I have no doubt they
will be hit. And with that we'll wrap up today's episode.
A big thank you again to Rob Berrow, CEO of
Mindmed for being with us. If you enjoyed this conversation,
(38:57):
don't forget to leave a review and hit the fo
Hello Bien on your favorite podcast app. That way, you
won't miss any of our upcoming discussions with leaders driving
innovation and healthcare. I'm John Rivera Rozari, and you've been
listening to the Vanguards of Health podcast by Bloomberg Intelligence.
Until next time, take care,
Host
Jonathan Palmer
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