January 1, 2025 • 14 mins
Dr. Jim Brown from DURECT talks about their clinical trials for Alcohol-Associated Hepatitis, a condition for which there is no approved treatment.
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Dr. Moira Gunn (00:11):
Well over a 100000 people each year check
into emergency rooms withalcohol associated hepatitis.
It's not surprising that duringthe pandemic, this number
jumped. There is no approvedtreatment, and frankly, the
prognosis is grim. Doctor JimBrown is the president and CEO
(00:33):
of DURECT. When I spoke withhim, DURECT's potential
treatment for this condition hadjust entered its phase 2b
clinical trial.
And now, doctor Jim Brown.
Dr. Jim Brown (00:46):
It's a big problem. And, unfortunately,
during the pandemic, we've seenan increase in the United States
of alcohol consumption, that'sabout 30%. And this has been
associated with as well,hospitalizations due to alcohol
have increased by about 50%. Andthe most common reason for this
(01:07):
is a a disease called alcoholassociated hepatitis.
Dr. Moira Gunn (01:10):
Mostly when I think of hepatitis, I think of
hepatitis c or hepatitis b.You've got a virus. You've got
this is entirely caused bydrinking alcohol?
Dr. Jim Brown (01:21):
It is. It's an inflammatory process. Actually,
it's much more than that. Veryinvolved process. But it's an
acute assault on your liverthat's brought on most typically
by binge drinking.
And, and the patients presentwith, with fever. They have
yellowing of the whites of theireyes known as jaundice. They're
(01:41):
tired. They'll often have nauseaand vomiting, and they always
have a history of recent heavyalcohol consumption or, binge
drinking.
Dr. Moira Gunn (01:49):
Is there a particular age group that's
that's targeted here?
Dr. Jim Brown (01:53):
You know, it's it's interesting. There are
about a 130,000 hospitalizationsper year for, for alcohol
associated hepatitis, which weabbreviate as Ah in the United
States. And about half thosepeople are between the ages of
40 to 60. Many of them will havecirrhosis, but it's really
interesting and this populationis on the rise. There are more
than 20% are younger people.
(02:13):
There are people in theirtwenties thirties. They don't
have cirrhosis. But there isjust more of a culture out there
in, in the millennial generationof going out drinking on
Wednesdays Thursday nights, andit and can add up to some people
in some circumstances.
Dr. Moira Gunn (02:28):
Is there a standard of care for this? Is
there a way to deal with thisonce they're in the hospital?
Dr. Jim Brown (02:34):
Unfortunately, there really isn't, and and it's
a deadly disease. The mortalityof patients with Ah is 26% at 1
month and it's about 30% at 3months and there is no approved
therapy today. They will useabstinence, of course. Standard
of care will be supportive care.Sometimes they'll use steroids,
(02:55):
but they've been shown not toimprove survival.
And in fact, unfortunately, thetreatment for Ah has not
improved, since the 19seventies. In in the last 50
years, there's been no change inthe survival of these patients.
Dr. Moira Gunn (03:08):
Now from Durex perspective, what actually goes
wrong in the body?
Dr. Jim Brown (03:14):
You know, we've all heard about DNA. You know,
it's the molecule and thenucleus of all the cells in your
body. It's effectively theblueprint of your body. You
inherit the DNA from your motherand your father. You have the
same blueprint in every cell inyour body, but think about all
the different cell types tissuesthat you have.
You know, you've got hair, skin,muscle, bone, and that's because
the epigenome allows for thisDNA blueprint to be read. But
(03:37):
But if you look in the nucleusof a cell, only about 5% of
what's in there is the DNA. Theother 95% is the epigenome,
which is effectively the brainsof the operation that allows
those genes to be expressed.Back when I was in school, we
were taught that the thestructures inside the nucleus
cells were called histones, andthey were there for structural
basis. And now we know they'reactually way more than that.
(03:58):
They are driving the reading ofthe blueprint as it were.
Dr. Moira Gunn (04:01):
They they're not just holding up the roof.
Dr. Jim Brown (04:04):
No. Not at all.
Dr. Moira Gunn (04:05):
Not at all.
Dr. Jim Brown (04:06):
And in fact, with a disease like Ah and with many
other diseases, you getdysregulation of this epigenome.
And so you have certain genesturned on and turned off and and
then you can move the celltowards unfortunately, disease
states can move the cellstowards death and, and, you
know, the outcomes that you getwith the disease like Ah.
Dr. Moira Gunn (04:26):
So when you say dysregulation, you mean,
normally, the the 95%, the theepigenome there is operating on
the 5% DNA. Everything's workingout great. But when there's a
problem, it starts going awry.It's either not working or it's
doing things it shouldn't do,and that's called dysregulation.
Dr. Jim Brown (04:48):
That's absolutely right. And we, until now, have
known very little about it. Wedo use, medicine that changes
the epigenome in the field ofoncology to kill cancer cells.
What you do there is you go inand you disrupt the epigenome
and the cells will die. Butwith, what we're doing at
Direct, we have an opportunityto actually repair the epigenome
(05:11):
to bring it back more towardsnormal, and that has allowed for
a a greater understanding of, ofthis component of biology and
medicine.
It's fascinating.
Dr. Moira Gunn (05:20):
I'm assuming with alcoholic hepatitis that
your liver isn't workinganymore. So we're talking about
this dysregulation inside livercells. So, when this goes awry,
we're talking about liver cellsthat aren't functioning anymore.
And then, I guess, your liverisn't functioning anymore?
Dr. Jim Brown (05:38):
That's absolutely true. And it starts with the
liver and then, unfortunately,goes to other organs. But just,
you know, to focus on the livercells themselves right now, the
literature has, told us thatwhat happens in these Ah
patients is the epigenomebecomes dysregulated and,
through a process calledhypermethylation. It's very
(06:01):
specific. We don't have to getinto that.
But the reality of it is thesemajor pathways in these cells
are shut down. And so a lot ofgenes are turned off that
shouldn't be and genes areturned on that shouldn't be. And
you end up going down theprocess of cell death and
dysregulation, which not onlydamages the liver, but
eventually extends to thekidneys and the lungs as well
(06:21):
and get multi organ damage.
Dr. Moira Gunn (06:23):
Now I know at Direct, you're working and have
been working for some time witha molecule called DUR 928. What
is that? What does it do? Howdoes it relate to Ah?
Dr. Jim Brown (06:37):
Yes. DUR 928, it's a naturally occurring
regulatory molecule that's foundin all of us, actually. In fact,
we've looked at it in in manydifferent species of mammals
from, things as small as mice inHampshire's all the way up to
monkeys, dogs, pigs, and humans,and we all have the same
concentration in our body. It'sfascinating in that it is made
in association with themitochondria. It travels to the
(06:58):
nucleus, and it helps maintainhomeostasis as it were of the
epigenome and cellular function,not of the liver not only of the
liver but of many many othercells.
So what we've been able to dowith the U R 928 is show in a
number of cell culture modelsand a number of, of other models
that it's able to restorefunction of the cells. And we've
(07:20):
also now been able to use it inAh patients and show that it
improves the function of, thesepatients as well.
Dr. Moira Gunn (07:30):
Now you've gone through phase 1. We know it's
safe for humans, and you did a 2a, that initial study. And
according to my notes, 19patients just to try to see what
happened. What what was thatstudy about? What did you do
with those 19 patients?
Dr. Jim Brown (07:45):
Well, first off, as, you know, we've been talking
about, Ah is a horrible disease.26% of Ah patients die within a
month and 30% die within 3months. In our first study, as
you talked about, we had 19patients and they all lived over
that 28 day study. And I thinkwhat's equally as impressive as
(08:06):
that is 14 of these 19 patientsleft the hospital within 3 days
of their first dose and theironly dose of 928. So that speaks
to some of the epigenomiccomponent of this.
We're restoring the function ofthe epigenome of the nucleus of
these cells, just a singleintervention in 14 to 19
patients. And if you think aboutit, most of the time, those
(08:28):
patients would be in thehospital for weeks and,
unfortunately, a third of themwould never go home. And in this
case, 14 to 19 walked homebefore day 4.
Dr. Moira Gunn (08:36):
So what's your next your phase 2 b, I guess,
would be the next one. What areyou doing there?
Dr. Jim Brown (08:41):
It's a trial in 300 patients, with severe Ah.
We're testing 2 different dosesof 928, and we're also testing
against, the standard of care,which is, you know, supportive
care of these patients, a 100patients per group. And the
endpoint of this trial will besurvival at 90 days.
Dr. Moira Gunn (08:58):
Now no one signs up for this trial in advance. No
one. No one says I'm gonna go ona binge, but I wanna get all the
paperwork out of the way. Andyet these are extremely sick
patients. How do they how do youfind them, and how do they how
are they able to give theirconsent to this, entry?
Dr. Jim Brown (09:19):
That's a really good point. You know, we have
explored the potential ofduronite28 in a number of acute
diseases, things like sepsis oracute kidney disease, and we can
talk more about these later. Butthe reason we selected Ah for
our first indication is becauseunlike a a stroke, for example,
where if, I had a stroke and Ihad a twin brother who had a
stroke and there was a 12 hourdelay between myself getting in
(09:41):
there and my brother getting inthere 12 hours earlier, he's
gonna have a better outcome justbecause of supportive care. So
you had a lot you have a lot ofpatient variability in in stroke
trials and sepsis trials andkidney trials, and you see these
with with, you know, verydifficult, paths to approval for
drugs in these areas. With Ah,the disease is a very insidious
disease and and the people dieover a month or 2 months or 3
(10:03):
months, but it's a very slowprocess.
So that's, the circumstance thatis different with Ah. It's a
slow insidious process that ifone can intervene, potentially
one can make a difference andsave someone's life.
Dr. Moira Gunn (10:16):
Now what other diseases or conditions are
caused by these kind of problemswith the epigenome that might be
helped with DUR 928?
Dr. Jim Brown (10:25):
Yes. The diseases we're looking at and where we
have tested this in variousmodels and shown that it helps
is in in diseases like acutekidney injury or in diseases
like sepsis where you haveendotoxin, super high amounts of
endotoxin, or things likeoverdose of of Tylenol or acute
(10:46):
pancreatitis. These are allcases where 928 has been shown
to work. In some of these cases,we don't know yet whether
there's hypermethylation. Sothis is a case where the drug is
maybe leading the the the wayforward in the in the path for
under better understanding ofthe disease.
It's it's kind of a hand inglove thing. We we understand in
some cases there'shypermethylation. We can move in
(11:08):
with DUR 928 and help treat theepigenome. In other cases, we
know DUR 928 helps in this, atleast in this animal model,
should be able to help inhumans. And then we'll go in
there and then find out whetheror not there is
hypermethylation.
Dr. Moira Gunn (11:22):
I think this is fascinating. Usually, we think
there's a condition. Let's givethe person the drug. Let's see
if it cures what it is you'resaying. Sometimes just giving
the drug gives us informationabout how this is whole system
works.
Dr. Jim Brown (11:37):
Absolutely. Yeah. This is a this is a very
different way of thinking aboutmedicine. You know, I was raised
and and and and went throughschool during a time when when
drugs were much simpler. Youwould simply have a drug like a
like a statin, for example, thatthat inhibits one of the enzymes
in making cholesterol.
So if you have high cholesterol,you give this drug, it reduces
(11:58):
the production of, you know, ofcholesterol at that one point,
but you get buildup of of, youknow, predecessor molecules and
you get side effects and all therest of these kind of things.
With DUR 928, we're changing thewhole set point of a cell. And,
because of that, which isanother fascinating thing about
this, we've really not seen muchat all in the way of side
(12:20):
effects with this drug in themost seriously ill patients one
can think of, And, and that'sbeen fascinating. It's been a
very safe drug to use.
Dr. Moira Gunn (12:28):
Now very interesting for me is that
you're a doctor of veterinarymedicine, not an MD, not a PhD
in microbiology or all thenormal folks that walk through
my door here. Why is abackground in veterinary
medicine a good thing here?
Dr. Jim Brown (12:44):
I think it's for me, it's worked out really well,
obviously. I've I've I've it'sbeen a great career and I've
really enjoyed it. I I stillhave my license to practice
veterinary medicine here inCalifornia and I enjoy doing
that. But the reality of it isit gives me, I think, really
good insight because I can lookat animal models of certain
disease states and, and look andsee how it might apply to human
(13:07):
medicine. And, and we're all youknow, we like to think of
ourselves in such a differentway as as humans, but we're all
animals.
Right? Humans are are, you know,5 to 6 foot primates typically
walking around. You know, andwith veterinary medicine, they
get the great opportunity to beable to understand the the
physiology and and diseasecircumstances, of primates, but
(13:27):
also of, you know, horses andruminants and, dolphins and all
the different kind of speciesthat are out there. So it's a
it's a it's a great multiple,you know, approach to, to
disease. But yeah.
Dr. Moira Gunn (13:42):
Well, I really appreciate you coming in, Tim. I
hope you'll come back and see usagain.
Dr. Jim Brown (13:46):
Oh, thank you so much, Moira. I really appreciate
the opportunity, and I lookforward to it, anytime.
Dr. Moira Gunn (13:51):
DURECT's phase 2b clinical trial is now
complete with what doctor Browndescribes as compelling results.
They anticipate having their endof phase 2 meeting with the FDA
shortly and to begin discussionson the design for the phase
three trial. Doctor Jim Brown isthe president and CEO of DURECT.
(14:14):
More information is available atdurect dotcom. That's
durectdirect.com.
Well over a 100000 people each year check
into emergency rooms withalcohol associated hepatitis.
It's not surprising that duringthe pandemic, this number
jumped. There is no approvedtreatment, and frankly, the
prognosis is grim. Doctor JimBrown is the president and CEO
(00:33):
of DURECT. When I spoke withhim, DURECT's potential
treatment for this condition hadjust entered its phase 2b
clinical trial.
And now, doctor Jim Brown.
Dr. Jim Brown (00:46):
It's a big problem. And, unfortunately,
during the pandemic, we've seenan increase in the United States
of alcohol consumption, that'sabout 30%. And this has been
associated with as well,hospitalizations due to alcohol
have increased by about 50%. Andthe most common reason for this
(01:07):
is a a disease called alcoholassociated hepatitis.
Dr. Moira Gunn (01:10):
Mostly when I think of hepatitis, I think of
hepatitis c or hepatitis b.You've got a virus. You've got
this is entirely caused bydrinking alcohol?
Dr. Jim Brown (01:21):
It is. It's an inflammatory process. Actually,
it's much more than that. Veryinvolved process. But it's an
acute assault on your liverthat's brought on most typically
by binge drinking.
And, and the patients presentwith, with fever. They have
yellowing of the whites of theireyes known as jaundice. They're
(01:41):
tired. They'll often have nauseaand vomiting, and they always
have a history of recent heavyalcohol consumption or, binge
drinking.
Dr. Moira Gunn (01:49):
Is there a particular age group that's
that's targeted here?
Dr. Jim Brown (01:53):
You know, it's it's interesting. There are
about a 130,000 hospitalizationsper year for, for alcohol
associated hepatitis, which weabbreviate as Ah in the United
States. And about half thosepeople are between the ages of
40 to 60. Many of them will havecirrhosis, but it's really
interesting and this populationis on the rise. There are more
than 20% are younger people.
(02:13):
There are people in theirtwenties thirties. They don't
have cirrhosis. But there isjust more of a culture out there
in, in the millennial generationof going out drinking on
Wednesdays Thursday nights, andit and can add up to some people
in some circumstances.
Dr. Moira Gunn (02:28):
Is there a standard of care for this? Is
there a way to deal with thisonce they're in the hospital?
Dr. Jim Brown (02:34):
Unfortunately, there really isn't, and and it's
a deadly disease. The mortalityof patients with Ah is 26% at 1
month and it's about 30% at 3months and there is no approved
therapy today. They will useabstinence, of course. Standard
of care will be supportive care.Sometimes they'll use steroids,
(02:55):
but they've been shown not toimprove survival.
And in fact, unfortunately, thetreatment for Ah has not
improved, since the 19seventies. In in the last 50
years, there's been no change inthe survival of these patients.
Dr. Moira Gunn (03:08):
Now from Durex perspective, what actually goes
wrong in the body?
Dr. Jim Brown (03:14):
You know, we've all heard about DNA. You know,
it's the molecule and thenucleus of all the cells in your
body. It's effectively theblueprint of your body. You
inherit the DNA from your motherand your father. You have the
same blueprint in every cell inyour body, but think about all
the different cell types tissuesthat you have.
You know, you've got hair, skin,muscle, bone, and that's because
the epigenome allows for thisDNA blueprint to be read. But
(03:37):
But if you look in the nucleusof a cell, only about 5% of
what's in there is the DNA. Theother 95% is the epigenome,
which is effectively the brainsof the operation that allows
those genes to be expressed.Back when I was in school, we
were taught that the thestructures inside the nucleus
cells were called histones, andthey were there for structural
basis. And now we know they'reactually way more than that.
(03:58):
They are driving the reading ofthe blueprint as it were.
Dr. Moira Gunn (04:01):
They they're not just holding up the roof.
Dr. Jim Brown (04:04):
No. Not at all.
Dr. Moira Gunn (04:05):
Not at all.
Dr. Jim Brown (04:06):
And in fact, with a disease like Ah and with many
other diseases, you getdysregulation of this epigenome.
And so you have certain genesturned on and turned off and and
then you can move the celltowards unfortunately, disease
states can move the cellstowards death and, and, you
know, the outcomes that you getwith the disease like Ah.
Dr. Moira Gunn (04:26):
So when you say dysregulation, you mean,
normally, the the 95%, the theepigenome there is operating on
the 5% DNA. Everything's workingout great. But when there's a
problem, it starts going awry.It's either not working or it's
doing things it shouldn't do,and that's called dysregulation.
Dr. Jim Brown (04:48):
That's absolutely right. And we, until now, have
known very little about it. Wedo use, medicine that changes
the epigenome in the field ofoncology to kill cancer cells.
What you do there is you go inand you disrupt the epigenome
and the cells will die. Butwith, what we're doing at
Direct, we have an opportunityto actually repair the epigenome
(05:11):
to bring it back more towardsnormal, and that has allowed for
a a greater understanding of, ofthis component of biology and
medicine.
It's fascinating.
Dr. Moira Gunn (05:20):
I'm assuming with alcoholic hepatitis that
your liver isn't workinganymore. So we're talking about
this dysregulation inside livercells. So, when this goes awry,
we're talking about liver cellsthat aren't functioning anymore.
And then, I guess, your liverisn't functioning anymore?
Dr. Jim Brown (05:38):
That's absolutely true. And it starts with the
liver and then, unfortunately,goes to other organs. But just,
you know, to focus on the livercells themselves right now, the
literature has, told us thatwhat happens in these Ah
patients is the epigenomebecomes dysregulated and,
through a process calledhypermethylation. It's very
(06:01):
specific. We don't have to getinto that.
But the reality of it is thesemajor pathways in these cells
are shut down. And so a lot ofgenes are turned off that
shouldn't be and genes areturned on that shouldn't be. And
you end up going down theprocess of cell death and
dysregulation, which not onlydamages the liver, but
eventually extends to thekidneys and the lungs as well
(06:21):
and get multi organ damage.
Dr. Moira Gunn (06:23):
Now I know at Direct, you're working and have
been working for some time witha molecule called DUR 928. What
is that? What does it do? Howdoes it relate to Ah?
Dr. Jim Brown (06:37):
Yes. DUR 928, it's a naturally occurring
regulatory molecule that's foundin all of us, actually. In fact,
we've looked at it in in manydifferent species of mammals
from, things as small as mice inHampshire's all the way up to
monkeys, dogs, pigs, and humans,and we all have the same
concentration in our body. It'sfascinating in that it is made
in association with themitochondria. It travels to the
(06:58):
nucleus, and it helps maintainhomeostasis as it were of the
epigenome and cellular function,not of the liver not only of the
liver but of many many othercells.
So what we've been able to dowith the U R 928 is show in a
number of cell culture modelsand a number of, of other models
that it's able to restorefunction of the cells. And we've
(07:20):
also now been able to use it inAh patients and show that it
improves the function of, thesepatients as well.
Dr. Moira Gunn (07:30):
Now you've gone through phase 1. We know it's
safe for humans, and you did a 2a, that initial study. And
according to my notes, 19patients just to try to see what
happened. What what was thatstudy about? What did you do
with those 19 patients?
Dr. Jim Brown (07:45):
Well, first off, as, you know, we've been talking
about, Ah is a horrible disease.26% of Ah patients die within a
month and 30% die within 3months. In our first study, as
you talked about, we had 19patients and they all lived over
that 28 day study. And I thinkwhat's equally as impressive as
(08:06):
that is 14 of these 19 patientsleft the hospital within 3 days
of their first dose and theironly dose of 928. So that speaks
to some of the epigenomiccomponent of this.
We're restoring the function ofthe epigenome of the nucleus of
these cells, just a singleintervention in 14 to 19
patients. And if you think aboutit, most of the time, those
(08:28):
patients would be in thehospital for weeks and,
unfortunately, a third of themwould never go home. And in this
case, 14 to 19 walked homebefore day 4.
Dr. Moira Gunn (08:36):
So what's your next your phase 2 b, I guess,
would be the next one. What areyou doing there?
Dr. Jim Brown (08:41):
It's a trial in 300 patients, with severe Ah.
We're testing 2 different dosesof 928, and we're also testing
against, the standard of care,which is, you know, supportive
care of these patients, a 100patients per group. And the
endpoint of this trial will besurvival at 90 days.
Dr. Moira Gunn (08:58):
Now no one signs up for this trial in advance. No
one. No one says I'm gonna go ona binge, but I wanna get all the
paperwork out of the way. Andyet these are extremely sick
patients. How do they how do youfind them, and how do they how
are they able to give theirconsent to this, entry?
Dr. Jim Brown (09:19):
That's a really good point. You know, we have
explored the potential ofduronite28 in a number of acute
diseases, things like sepsis oracute kidney disease, and we can
talk more about these later. Butthe reason we selected Ah for
our first indication is becauseunlike a a stroke, for example,
where if, I had a stroke and Ihad a twin brother who had a
stroke and there was a 12 hourdelay between myself getting in
(09:41):
there and my brother getting inthere 12 hours earlier, he's
gonna have a better outcome justbecause of supportive care. So
you had a lot you have a lot ofpatient variability in in stroke
trials and sepsis trials andkidney trials, and you see these
with with, you know, verydifficult, paths to approval for
drugs in these areas. With Ah,the disease is a very insidious
disease and and the people dieover a month or 2 months or 3
(10:03):
months, but it's a very slowprocess.
So that's, the circumstance thatis different with Ah. It's a
slow insidious process that ifone can intervene, potentially
one can make a difference andsave someone's life.
Dr. Moira Gunn (10:16):
Now what other diseases or conditions are
caused by these kind of problemswith the epigenome that might be
helped with DUR 928?
Dr. Jim Brown (10:25):
Yes. The diseases we're looking at and where we
have tested this in variousmodels and shown that it helps
is in in diseases like acutekidney injury or in diseases
like sepsis where you haveendotoxin, super high amounts of
endotoxin, or things likeoverdose of of Tylenol or acute
(10:46):
pancreatitis. These are allcases where 928 has been shown
to work. In some of these cases,we don't know yet whether
there's hypermethylation. Sothis is a case where the drug is
maybe leading the the the wayforward in the in the path for
under better understanding ofthe disease.
It's it's kind of a hand inglove thing. We we understand in
some cases there'shypermethylation. We can move in
(11:08):
with DUR 928 and help treat theepigenome. In other cases, we
know DUR 928 helps in this, atleast in this animal model,
should be able to help inhumans. And then we'll go in
there and then find out whetheror not there is
hypermethylation.
Dr. Moira Gunn (11:22):
I think this is fascinating. Usually, we think
there's a condition. Let's givethe person the drug. Let's see
if it cures what it is you'resaying. Sometimes just giving
the drug gives us informationabout how this is whole system
works.
Dr. Jim Brown (11:37):
Absolutely. Yeah. This is a this is a very
different way of thinking aboutmedicine. You know, I was raised
and and and and went throughschool during a time when when
drugs were much simpler. Youwould simply have a drug like a
like a statin, for example, thatthat inhibits one of the enzymes
in making cholesterol.
So if you have high cholesterol,you give this drug, it reduces
(11:58):
the production of, you know, ofcholesterol at that one point,
but you get buildup of of, youknow, predecessor molecules and
you get side effects and all therest of these kind of things.
With DUR 928, we're changing thewhole set point of a cell. And,
because of that, which isanother fascinating thing about
this, we've really not seen muchat all in the way of side
(12:20):
effects with this drug in themost seriously ill patients one
can think of, And, and that'sbeen fascinating. It's been a
very safe drug to use.
Dr. Moira Gunn (12:28):
Now very interesting for me is that
you're a doctor of veterinarymedicine, not an MD, not a PhD
in microbiology or all thenormal folks that walk through
my door here. Why is abackground in veterinary
medicine a good thing here?
Dr. Jim Brown (12:44):
I think it's for me, it's worked out really well,
obviously. I've I've I've it'sbeen a great career and I've
really enjoyed it. I I stillhave my license to practice
veterinary medicine here inCalifornia and I enjoy doing
that. But the reality of it isit gives me, I think, really
good insight because I can lookat animal models of certain
disease states and, and look andsee how it might apply to human
(13:07):
medicine. And, and we're all youknow, we like to think of
ourselves in such a differentway as as humans, but we're all
animals.
Right? Humans are are, you know,5 to 6 foot primates typically
walking around. You know, andwith veterinary medicine, they
get the great opportunity to beable to understand the the
physiology and and diseasecircumstances, of primates, but
(13:27):
also of, you know, horses andruminants and, dolphins and all
the different kind of speciesthat are out there. So it's a
it's a it's a great multiple,you know, approach to, to
disease. But yeah.
Dr. Moira Gunn (13:42):
Well, I really appreciate you coming in, Tim. I
hope you'll come back and see usagain.
Dr. Jim Brown (13:46):
Oh, thank you so much, Moira. I really appreciate
the opportunity, and I lookforward to it, anytime.
Dr. Moira Gunn (13:51):
DURECT's phase 2b clinical trial is now
complete with what doctor Browndescribes as compelling results.
They anticipate having their endof phase 2 meeting with the FDA
shortly and to begin discussionson the design for the phase
three trial. Doctor Jim Brown isthe president and CEO of DURECT.
(14:14):
More information is available atdurect dotcom. That's
durectdirect.com.
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