John Alam, MD – Chief Executive Officer of CervoMed Inc., was recently a guest on Benzinga's All-Access. CervoMed is a clinical-stage company dedicated to the development and commercialization of targeted drug treatments for neurodegenerative diseases with a focus on the early stages of the disease process. Mr. Alam spoke of the promising topline results from the ongoing phase 2b trial of its lead drug candidate.
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00:00Dan Leach here with you.
00:05It's my pleasure to welcome the CEO of ServoMed, Dr. John Alam.
00:09It's so great to be with you today.
00:12Hey, Dan.
00:12Great, great to be here.
00:14Thanks for having us.
00:16You know, we were on about a year ago in Benzinga.
00:20A lot of things have happened in the past year and we're right where we
00:24want to be.
00:26We're weeks away from a big data readout and I think what will end up
00:30becoming a really a breakthrough for a really important disease, bad
00:38disease, dementia with Lewy bodies, and we're just about there.
00:43It's a great time to be here.
00:44It is.
00:45And listen, it's a disease that affects so many people.
00:48I've had people in my life that it's affected.
00:50So very excited to kind of dive into where you guys are at in this
00:54great news.
00:55It's hopefully coming but you know, for those that don't know a doctor,
00:58can you give us an overview of the company of ServoMed?
01:02Yeah, so we're a Boston-based biotech emerging pharma company.
01:09We've been in business for some years now as a private company about a
01:13year ago.
01:14We did a reverse merger with a public company, became a publicly listed
01:19company on NASDAQ, CRVO, ServoMed.
01:23What distinguishes us I think in our space is, you know, aside from the
01:28science is just the DNA of the company, the leadership team and that
01:34goes into the board of directors, into our SAB, really at the heart of
01:42Boston Biotech for the last 20-30 years now.
01:45A lot of drug development experience, experience with big drugs, getting
01:50them onto the market.
01:52And I think what's most important for investors is with that, you know,
01:56building companies.
01:57Some of the biggest names, you know, in biotech, you know, various parts
02:02of our leadership team and our board have been involved with some of
02:06those companies.
02:07And we've put that to work in the CNS arena, in particular on an oral
02:13drug, nephlamapimode, that we've been progressing to.
02:17Again, we are with that today.
02:20We're the leader in developing the first, what we believe will be,
02:24well, ultimately has a potential to be and will become, we hope, the
02:30first effective drug for dementia with Lewy bodies.
02:33It's amazing.
02:34And that experience, as you mentioned, launching those big drugs is
02:36such a key, especially when you're tackling such a terrible situation
02:40that dementia, you know, causes so many.
02:42And speaking of that dementia and obviously neurodegenerative diseases
02:45or other terrible afflictions, doctor, and what portion of the U.S.
02:48is affected?
02:49And also, is this growing?
02:51And if so, why?
02:53So we are in one very specific arena of the overall Alzheimer's or
03:01dementia universe.
03:03I think most people are very familiar with Alzheimer's disease, but
03:07you know, a lot of people are less familiar with dementia with Lewy
03:11bodies.
03:11This is actually the third most common chronic neurodegenerative
03:15disease.
03:16There's Alzheimer's, there's Parkinson's, and right behind Parkinson's
03:19is dementia with Lewy bodies.
03:21It's 700,000 patients in the U.S.
03:24It's very similar in numbers to the number of people that are impacted
03:28with multiple sclerosis.
03:30Of that group, we are targeting about half of that, which are in a
03:35stage of disease that is called the synaptic dysfunction disease.
03:41It's the early stage where they have a lot of symptoms.
03:45They have a lot of impact on the patient lives, on caregiver burden,
03:50but they're not at the point where the disease is actually, in certain
03:53respects, a full-blown neurodegenerative disease.
03:56They don't have so much nerve cell death and loss as much as a problem
04:01in a certain part of the brain and how well it's functioning.
04:06And if you have the right drug and mechanism, you can actually make
04:10them better and have a real substantive impact in the relatively
04:16short term.
04:17That's what we're seeing in our clinical study and going forward.
04:20As a disease, it is a dementia like Alzheimer's disease, and it's
04:25very distinct, but there are two things that's important to know
04:28about it.
04:29One is that, in most respects, it's a worse disease in the early
04:34stages in particular than Alzheimer's in terms of impact, quality
04:38of life, caregiver burden, health care costs, how rapidly it progresses.
04:44Also important to know is that today, as opposed to maybe 10-15 years
04:49ago, with the diagnostic criteria, a neurologist can distinguish
04:54dementia with Lewy bodies specifically as opposed to having Alzheimer's
05:00disease.
05:03Sometimes they don't pick it up.
05:05They call it Alzheimer's disease, but if it's diagnosed appropriately
05:10and they have the features clinically of what dementia with Lewy
05:14bodies is, high certainty that's what it is.
05:18And that's what our drug is ideally suited for and tailored for, is
05:22that a patient with DLB.
05:24Well, doctor, let's talk about how your drug does treat it and what
05:28is the mechanism and also how is this approach novel for what you
05:32guys are doing with this, which is obviously a very serious condition.
05:36So for dementia with Lewy bodies, this is a very specific and targeted
05:41therapy.
05:43And what it's going after is neuroinflammation, inflammation, not
05:48to try to reduce it, but to block the effects of inflammation on a
05:52very specific part of the brain.
05:54It's a mouthful.
05:55It's called a basal forebrain cholinergic system, but it's a part
06:00of the brain that is most impacted in DLB and it is the part of the
06:06brain that leads to the actual symptoms and the expression of the
06:12disease and the progression of the disease.
06:14Our drug, we've shown in animals, actually an independent academic
06:19lab has shown that it acts on that part of the brain, on the specific
06:23molecular mechanisms that leads to disease and actually reverses the
06:27process within that process.
06:30And if you can put that slide back up, all of that we have shown in
06:36again, in animals, in earlier clinical studies, effects on the
06:40clinical endpoints, effects on very specific biomarkers, blood tests,
06:45markers of that disease process in that part of the brain.
06:50And we're now using all that information.
06:53We designed this clinical study.
06:56It's a larger study.
06:57It's a large study, 159 patients, 16-week placebo-controlled study.
07:03It's definitive proof-of-concept study.
07:05It's designed to show the drug works.
07:09It's an effective treatment in dementia with Lewy bodies.
07:14We started this study a little over a year ago.
07:16We completed enrollment in June, and last patient, last visit was in
07:23October for this, the primary efficacy endpoint.
07:26We'll have the data in December.
07:28But what's important for the viewer and listener to know is that this is
07:33not a blind shot in the dark study.
07:36There's a lot of understanding of disease, science, drug.
07:41There's a lot of clinical data that we have already.
07:43That informed on designing this study, on the patient population, on
07:50the endpoint being studies, but the most important point is we're
07:56using a blood test to exclude the more advanced disease patients and
08:01focus in on that early stage population.
08:04Again, that makes up about half of all DLB patients.
08:07In our prior study, in that population, we saw really unprecedented
08:12levels of clinical activity.
08:14Moderate to large treatment effect size.
08:16We saw an effect on a blood test of the neurodegenerative process.
08:21It's actually correlated to the clinical outcome.
08:25That's almost never seen in CNS studies to have such good effects
08:30that you can connect everything together.
08:33All of that gives us good confidence in this study.
08:37I think we were at the major Alzheimer's disease and related dementia
08:45conference three weeks ago in Madrid.
08:50We were outside of Lilly and Asi, the big boys.
08:55We were the only company that had two oral communications, oral
09:02plenary session communication.
09:04The reason is that the academic community recognizes the potential,
09:09the data that we have, specific targeting of the disease process
09:14and dementia with Lewy bodies.
09:16I think they believe that we have a really good shot in the study.
09:19If it reads out positive, in our mind, it really just is designed
09:29to and will show definitively efficacy in dementia with Lewy
09:33bodies, de-risk the phase three clinical study program.
09:39And I think all around the company will be off to the races, but
09:43it's just fundamentally, we will have shown that this is a breakthrough.
09:49We have a drug now that works in dementia with Lewy bodies and
09:55there's still time and money involved in running phase three before
09:59we're to approval, but for the community, for the patient, real
10:05hope of a drug that has shown efficacy in the dementia with Lewy
10:10bodies. We're weeks away.
10:13We have the data.
10:14Until it's done, it's not done, but we feel good about where we
10:20are. I love to hear that.
10:21I know there's millions of people out there that should feel that
10:24way as well.
10:25Let's talk about the Q3 numbers.
10:28I know you recently released your Q3 numbers.
10:30Any highlights from your perspective and how much of a runway do
10:34you feel like you guys have?
10:35I think the bottom line is that from what the Q3 release
10:43again highlights is that we are just from a financial standpoint,
10:48we're a very well-managed company.
10:51We did a pipe, a private placement in the spring that brought in
10:58$50 million and with that, at the end of Q3, we had cashed runway
11:05out to the end of next year.
11:07So 12 months beyond the data readout, the pipe was structured
11:12essentially as a two-step transaction.
11:14The second step has a warrants structure within it, but with
11:19positive data within the Phase 2b data and announcement, we would
11:24expect that second step transaction to be implemented.
11:28That would bring in another up to $99.4 million within the next
11:34six months or so.
11:34That's the timeline of when they would have to be exercised if we
11:39have top-line data and that will finance the clinical portion
11:44of the Phase 3 study.
11:46We're very disciplined.
11:51The money that's come into the company goes towards building value
11:56and all of the goals financially over the past year has been to put
12:02us in a position to have the dollars to get to this study and then
12:07execute it beyond it, go to the FDA, go into the Phase 3 program.
12:14Stepping back to just where we are, I will say that a lot of this is
12:20in dementia with Lewy bodies.
12:22What we're benefiting from is all the work and understanding that
12:27goes into Alzheimer's in terms of clinical trial design, using biomarkers
12:34to identify patient populations that have optimal responses, and just
12:39generally understanding underlying disease process.
12:43All of that took 20 years to build a lot of the translational
12:49platforms and longitudinal understanding, transitional understanding.
12:53It's being applied in real-time in DLB over the last two to three years.
12:58And as our data has come through from our prior study, we've been able
13:03to connect into that.
13:05Over the last year or so, I just search in PubMed, which is the
13:13library for scientific journals, every week or so, every two weeks
13:18for just dementia with Lewy bodies, and I'll cut something new.
13:21And we've been in real-time been able to implement that into the
13:26study design, into how we think about the drug and mechanism.
13:30And it's just, to me, it's been just great in how quickly things
13:36have moved.
13:37And that's what gives me hope.
13:39And I hope it's a fundamental message to the people who may be
13:45impacted with DLB or who know people who are with DLB who may be
13:49listening in.
13:50There is real reason to believe that there can be breakthroughs in
13:56this disease that five years ago, no one would have thought possible.
13:59But the field, the broader field, has made real progress here.
14:05And we're benefiting from that.
14:07And that's part of what gives me confidence in our data readout
14:12coming up.
14:13It's very exciting times.
14:15Obviously, you said it's a very hopeful time for a lot of different
14:18reasons. We do have a question for the chat, and they want me to ask
14:20you, Dr. Jatulab, what phase is the current study in right now?
14:24So it's what's called a phase 2B study.
14:28So it's our second study.
14:31But what's important about this is that it is a, we call it a phase
14:372B because it is what it's truly supposed to be, a true proof-of-concept
14:42study. And a true proof-of-concept study is that you can, you
14:48demonstrate, and your objective is, and if you meet your p-value in
14:53the study, you will have demonstrated that the drug has a clinically
14:58meaningful impact in the patients that you are studying. And that
15:04impact and true proof-of-concept leaves still, you have to do the
15:08phase 3 to study, but that phase 3 study is real confirmatory study.
15:15It's not asking a whole new question.
15:19And this has been one of the fundamental issues in Alzheimer's
15:23disease and neurodegenerative diseases that we go into phase 3
15:27without proof-of-concept. There's a much longer discussion of why
15:31that is, but it's the short answer is just that in Alzheimer's
15:35disease, because of the extent of neurodegeneration and nerve cell
15:38death and loss, you can only slow progression. And you can, and it
15:42takes a long time. So inherently, in a phase 2 study, which is six
15:47months, up between three and six months, you can't show a drug
15:50effect. You're always going into phase 3 without proof-of-concept.
15:54Phase 3 ends up becoming your proof-of-concept study. That's a lot
15:59of back-end risk to deal with. In early stage DLB, and contexts
16:06like that, when you have, don't have too much neuronal death and
16:11loss, you can get improvement, you can get short-term effects, you
16:16can get reversal, you can see efficacy in a three to six-month
16:22trial, as we saw in phase 2a, as we are working on to achieve in
16:28this ongoing study. And then most importantly, you can go to the,
16:33get approval and go to the market with a six-month study, which
16:39means that the six-month study is just replicating what you're
16:42doing in phase 2b. That's what makes Rewind LB a proof-of-concept
16:47study. So the answer is, more important than stage, it is that it's a
16:52proof-of-concept study. We are, the goal is to definitively
16:56demonstrate efficacy in a clinically meaningful way in dementia with
17:02Lewy bodies, and we believe we're going to achieve that with the
17:06top-line results that we are planning on, that we will announce
17:09next month.
17:10Yeah, you explained that beautifully and you guys are doing some
17:13beautiful things there that I know are giving people a lot of hope
17:15around the world. It was an absolute pleasure talking with you today,
17:18Dr. Alam. Thank you so much for your time and keep fighting that
17:21good fight. Well, great to talk to you.
17:24Thank you for all your kind comments and thank you to everyone
17:28listening in here and we'll keep you posted.