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239. Bull, Bear & Beyond – Cereno Scientific: executive interview
25 Plays7 days ago
In this interview, we speak with Dr Rahul Agrawal, chief medical officer and head of R&D at Cereno Scientific, about the latest findings from the Expanded Access Programme (EAP) for the company’s lead candidate, CS1, in pulmonary arterial hypertension (PAH). He discusses how investors should interpret the long-term safety and clinical observations in the context of the study’s exploratory design, limited patient population and the progressive nature of PAH. Rahul explains why the data provide meaningful support for CS1’s clinical profile, highlights its potential to complement existing PAH therapies, including sotatercept, and outlines how the EAP continues to strengthen the rationale for CS1 as a potential disease-modifying treatment. He also provides an update on preparations for the global Phase IIb trial and outlines the key development milestones investors should monitor over the coming months.
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About ‘Bull, Bear & Beyond’
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Transcript
Introduction
00:00:07
Speaker
Hello and welcome to another episode of Edison TV. I'm delighted to be joined today by Rahul Agrawal, Chief Medical Officer and Head of R&D at Serino Scientific.
Overview of CS1 Program
00:00:17
Speaker
Serino recently announced additional analysis from the Expanded Access Program for its lead candidate CS1.
00:00:25
Speaker
And today we'll be taking a closer look at what these latest findings mean for the program and the company's development plans. Rahul, welcome and thank you for joining us today.
Clinical Findings and Implications
00:00:35
Speaker
thank you very much So Rahul, you recently presented additional data from the expanded access program.
00:00:43
Speaker
Can you briefly summarize the key takeaways from this data set? Sure. um So the results of the extended access program are, if you would like, real world clinical observations of individual patient responses. So not in a controlled efficacy setting. This is something very important to bear in mind.
00:01:07
Speaker
And there, in a progressive disease like pulmonary arterial hypertension, we had very encouraging signals. Among the six patients who completed the 12 months of treatment, five of the six had a stable or even improved functional class.
00:01:28
Speaker
And this is something remarkable. We had included patients in function class two and three, and despite the long period that we have been observing, they're still stable or improving.
Significance of Results
00:01:41
Speaker
Similarly, five of the six had either a stable or improved biomarker of NT-proBNP, which is one of the primary biomarkers one looks at when one is ah following the development of the patients, the development of the disease, I should say.
00:01:59
Speaker
In addition to that, we also saw other markers like three of the six had a stable or improved reveal risk score. And there were even several who had ah improved six-month walking distance. All of this should be seen in the light of the fact that pulmonary arterial hypertension is a progressive disease. And even a stabilization is actually a big win for patients, for their caretakers and the physicians.
00:02:31
Speaker
And allow me to add maybe one more. And that is we had, as you may recall, also used CardiMEMS, a non-invasive continuous hemodynamic monitoring.
00:02:43
Speaker
And here we saw that three of the five evaluable patients had either a stable or a reduced mean pulmonary
Interpreting the Data
00:02:52
Speaker
artery pressure. So all in all, very promising signals that really give us even more positivity to progress into the Phase 2B trial, which will be in a controlled, randomized setting on a global level.
00:03:09
Speaker
So Rahul, looking at the incremental data presented from the EAB, We see that most of the patients who completed the program maintained or improved their clinical status over the 12 month follow-up period. But given the small number of patients and the fact that this wasn't a controlled study, how should investors interpret these results?
00:03:31
Speaker
Thank you very much, but allow me to maybe just take a step back. I would like to say that CS1 has reached an important milestone in its development. Based on the encouraging phase 2A results, we're now preparing for our phase 2B trial.
00:03:48
Speaker
Alongside that, our expanded access program has allowed us to gain valuable clinical experience in patients with pulmonary arterial hypertension. This is the indication we're working on with CS1.
00:04:05
Speaker
While, and this is something we should be always keeping in mind, while the extended access program, EAP, is not a clinical trial, it has played, we feel, an important role in the overall development of the program and has provided meaningful insights, if you would like, that complement our ongoing clinical research and the program that we're about to embark on.
00:04:31
Speaker
So, The primary purpose of the extended access program is to provide treatment access, not to generate statistically robust efficacy
Safety and Differentiation of CS1
00:04:43
Speaker
data.
00:04:43
Speaker
So all the patients that we're having, we're delighted that we're being able to give them give them access to our drug. This was at the request of the investigators as well as the patients.
00:04:58
Speaker
Great. and And the primary goal, like you mentioned, was to assess the long-term safety and tolerability of CS1 and not really efficacy. So what do these latest data tell us about CS1's safety profile, particularly for long-term use in patients with PAH?
00:05:16
Speaker
I think it is very important to note that our drug is a safe. and well tolerated drug with a long and well established record of the same, especially in the lower dosages.
00:05:30
Speaker
And keep in mind that this really differentiates us from many of the drugs which are on the market for the treatment of pulmonary arterial hypertension.
00:05:41
Speaker
ah And that's why we're really excited to evaluate now our compound, CS1, in a controlled clinical global setting, which we are embarking on now.
00:05:57
Speaker
Great. And just moving on to the Fluida imaging sub-study. Now, this did not yield significant findings. um Can you explain why only three patients were enrolled in this imaging study and how much weight should be
Future Prospects and Phase 2B Trials
00:06:14
Speaker
placed on these results? when assessing the overall AAP data?
00:06:18
Speaker
Thank you. And this very important question. Allow me to maybe correct you briefly that the results, they did not, that you were asking, that they did not reveal any important results.
00:06:32
Speaker
Allow me to just take a step back here again. First, Fluida was a sub-study of the exploratory andloratory component of the extended access program. So it was never intended to be a pivotal assessment or a basis for drawing definite conclusions.
00:06:52
Speaker
Number two, enrollment was limited because the subsidy required the patients to undergo highly specialized imaging at selected center. It was one center with three patients.
00:07:05
Speaker
And that's why we could enroll or it was only possible to enroll three patients. So given that small sample size, I don't think it's appropriate to really place significant weight from that exploratory analysis.
00:07:25
Speaker
Indeed, and actually it is really a hypothesis generating investigation that we did. The overall assessment of the EAP should be based on the totality of the evidence, which is again, something very positive. We saw positive signals regarding efficacy. We saw an in no deterioration of the functional class. We even saw a stabilization and an improvement in some, the same for some biomarkers. So all of these things are very encouraging signals to progress into our phase 2b trial, which we are right now also doing
00:08:05
Speaker
with full speed i ahead if I may put it that way. Great, I think this is quite useful to understand. And talking about encouraging signals, another encouraging aspect of the study was that CS1 appeared to be well-tolerated alongside existing PEH treatments, including Sotatacept, which has recently been approved. So how does this shape your thinking around where CS1 could fit in within the PEH treatment landscape?
00:08:32
Speaker
um We have to keep in mind that most of the drugs which are currently available are vasodilators. Sototracept has a different approach, but it did not show disease modification.
00:08:46
Speaker
We will be and we are planning to have the first disease modifying signals. And that is how we have also designed our phase to be trial. That means we will be having all the patients having all the standard of care drugs, including Sototracept, and we'll be giving on top of that CS1. So we think all these insights are very important to continue with more confidence and embark on this global phase to be trial. which we are about to initiate and the preparations are ongoing there. It is a big milestone for a biotech to be starting a global trial of this magnitude.
00:09:33
Speaker
That's great, Rahul. And you touched upon it right there, but can you just update us on how the preparations for the phase 2B study are going and what are some of the key milestones investors should be watching out for over the coming months?
00:09:46
Speaker
Yeah, I mean, as you can already hear from my responses, we are really excited with the imminent start of the Phase 2B trial. There are many pieces to puzzle together and documentation to get approved before starting a study.
00:10:02
Speaker
And the team is really working hard. Please keep in mind, we have a world-class steering committee with some of the top opinion leaders here. We have engaged with a top so CRO here, which has a a global network. We are trying to recruit really some of the foremost specialized pH centers in 12 countries. We have, ah we're planning on 65 sites with 125 patients. So we are really at a very good stage. We are nearing activation of the first clinical sites.
00:10:38
Speaker
We had our first investigators meeting already. And now we're looking forward to start screen the patients and enroll the first patient in the very near future.
00:10:50
Speaker
So there are really, these are really exciting times and naturally for every trial, because we are a very regulated industry and it is about
Closing Remarks
00:11:00
Speaker
patients. Naturally, we have to abide and look out for that we are doing everything in the correct fashion. That's why there are many administrative processes on a local, on a national and a global level that we have to respect and we're doing that.
00:11:18
Speaker
And so these are being finalized as we speak and we're really in the final stages of having hopefully the next milestones in the coming days and weeks. Excellent. And we look forward to the initiation of the Phase 2B study. Rahul, thank you very much for joining us today and sharing your insights into the expanded access program and the phase 2B plans.
00:11:41
Speaker
For our viewers keen to learn more about Serino Scientific, please visit EdisonGroup.com for our ongoing coverage of the company. Thank you very much for having me, Jyoti. Thank you again, Rahul.