Please note that this conference is being recorded. I now hand the conference over to Mr. Jaydeep Israni. Thank you, and over to you, sir.
Thank you, Michelle. Good evening ladies and gentlemen. My name is Jaydeep Israni. I head the Business Development and Investor Relations at SPARC. On behalf of SPARC, I welcome you to today's call and appreciate you for taking the time out on a Saturday evening to attend the call. I am joined by our CEO, Mr. Anil Raghavan, and the senior management team at SPARC. Anil will walk you through the presentation, which we have shared earlier, and, after his presentation, we will open the call for questions. Before we start, I would like to remind you that, I would like to remind you that our discussion today includes forward-looking statements that are subject to risks and uncertainties associated with our business. Hence, the actual results may be different from those projected in the presentation today. I will now hand it over to Mr. Anil Raghavan for his presentation. Over to you, Anil.
Thank you, Jaydeep. Good evening, everybody. Good morning or good afternoon, if you're joining internationally. Thank you for taking this call on short notice. We know it's been a very short notice for this call. I have four key objectives for this call. One, to provide an update on the Vodobatinib program. I want to set up our immediate priorities going into 2014, 2015 financial year for Vodobatinib, particularly after the data events that we are expecting. And, we also want to provide some perspective in terms of how to look at this program in balanced way. We've spoken about the opportunity extensively in our investor call earlier this year. Also want to give a sense of some of the risks that we're seeing in the program or associated with this kind of programs.
And finally, and probably most importantly, you know, this is an opportunity to answer any questions that you may have before we go into a quiet period on the interim analysis. With that, let's move to Slide 3. Do we have Slide number 3, Jaydeep? Can you confirm?
Yes. We have. We are on slide 3.
Okay. So Slide number 3, you know, we have a recap of the status of the program. We have touched upon some of this in our earlier call, Vodobatinib POC program, it's called PROSEEK, completed its enrollment target earlier this year, around October of 2023. Our target was 506 evaluable patients. We ended up with 513 patients globally. And the interim analysis, as communicated earlier, is planned with 85%-86% of patients. But the patient cutoff, enrollment cutoff is May of 2023. So we have 441 patients going into this interim analysis, and that is planned for late March, early April of 2024. And as we communicated earlier, the broader organization will be blinded.
Not just the broader organization, the external ecosystem or investigators and others who are participating in the trial will also be blinded because we will still have around 70-odd patients in different stages of treatment. And protecting the integrity of data from those patients is an important consideration for the trial and also the regulators in different countries. So in that sense, we are committed maintaining the blind and protecting this information to ensure that we don't induce unnecessary bias in conduct of the trial. So I spoke to the design of the program. We have covered that in many earlier conversations, but just to kind of give a very brief overview, this is two doses of Vodobatinib, 106 and 68 patients each.
In the original design interim, we entered a little more than that. 384 mg on the top dose, and 192 mg on the lower dose against a placebo compound, a placebo arm. As we've spoken about in the past, MDS-UPDRS Part III is the primary endpoint. We have also secondary endpoints and biomarker reads, which are mostly exploration. The study also has a Part II, this long-term extension study, where patients are on the drug for another 40 weeks. That's another roughly around 10 months. So these patients are still on Part A and Part B combined for almost 80 weeks, and those patients go through this 80-week period without any symptomatic therapy.
So that's the design of the program, and I have already talked about some of the milestones, like the interim analysis in April. The top-line data, the full top-line data for PROSEEK is expected in August, September of 2024. That's when we will have full disclosure on the data. Now, moving on to slide, the next slide has a listing of our near-term priorities post availability of data from PROSEEK. The primary objective at that time, in 2024, 2025, financially, is to ensure that we move on to the next phase of development without a phase lag, which is fortunate to have positive data and data in line with expectations of the hypothesis. That requires several steps. Most importantly, an agreement with regulatory agencies globally in terms of the nature of registration studies required.
So that would happen during the end of Phase II consultations with FDA and other important regulatory agencies globally. We hope to do that in short order after the August, September data call break. And in parallel, we will be continuing the long-term extension study of PROSEEK. And as soon as we have clarity in terms of the nature of the registrational studies required, we hope to initiate the pivotal program, the Phase III programs globally. And our strategic intent would be to minimize the, that lag between end of Phase II and initiation of Phase III.
And we will also be using this time right from the availability of independent analysis data to explore and finalize and execute a partnering strategy, so that, you know, as we move into a late stage development post PROSEEK, we can do that with a partner who we may be going with for commercialization of the asset. And as I said, the regulatory agreement is an important element in triggering this. And it is not just about additional clinical studies required. We may also require additional preclinical studies, particularly toxicity studies, and also additional steps to be taken for ensuring manufacturing robustness, particularly given the size and potential of this product. So let's go to the next slide.
So when we met you in the last quarter of 2023, for our annual investor update, we have spoken extensively about the program, the potential of the hypothesis and its implications on the standard of care of Parkinson's disease, and also more broadly, about the possibilities of diseases driven by asymmetry, and in the outer line of possibility, diseases that are driven by other proteins impacted by oxidative stress and GBA- linked activation. So we have spoken about the opportunity clearly. We thought that it is important, given, you know, some of the communication and coverage that we are seeing on this program recently, it's important to also highlight some of the risks, which are inherent in programs like this, especially in translation programs in neuroscience.
We want to highlight three or four major risks that you may want to keep in mind as you kind of think about these programs. One is the translatability of animal models in diseases like this. If you've seen, these animal models are built on, you know, intent to mimic the mechanism, underlying mechanism, and create the manifestation of diseases which can be addressed with the trial. While they are sound from a science standpoint, their true validation will come when programs which are developed with these models go on to clinic and get validated clinical data and go into market. In diseases like Parkinson's, you know, we haven't seen significant clinical translation in the long term, especially in disease-modifying therapies, which are, you know, designed to bend the neurodegenerative arc.
So we are one of the early companies which are, you know, trying to translate, the oxidative stress pathway, and, therefore, these models, carry a certain level of risk, and it is important to keep that in mind as you kind of evaluate this program. The other risk, a couple of other risks that I want to highlight. One is, about, about target engagement and, and dose. We have used, if you have followed, if you've been following this program, we've used the top dose in our animal models, that is 45 mg/kg , as a marker, for deciding our dose into the, Phase II clinical program. The mass, the brain exposure associated with the top dose in animal study, which is the most efficacious dose in animal studies.
In early clinical studies, the max that exposure in patients, I think, Parkinson's patients, CSF, which we believe is a good proxy for free levels in the brain. So even though the translation process is sound. This field clearly lacks a target engagement marker, because we cannot open the brain and see what happens. So there are challenges in terms of, you know, clearly getting appropriate dose in humans. So there is a certain level of approximation that is done with by extrapolating animal data. That may create a certain level of risk, which needs to be factored in. The third point that I want to highlight is the reproducibility of pre-clinical and early clinical studies, clinical proof of concept studies, as you think about repeating those results in later stage clinical setting.
Typically, if you look at companies which are doing early proof of concept studies, and they are more in the smaller pilot studies, and the most of this risk comes from inadequate powering of early studies. And that we have tried to address some of that in the design of the PROSEEK trial. PROSEEK is a Phase II program. It is an extensive study with 500+ patients, which is powered at around 80% power. So in that sense, even though we have tried to address some of the translational risk, that is some of the risk associated with reproducibility of early-stage clinical results in late-stage clinical programs, there is still a risk in the larger study in Phase III setting.
And the last point is, you know, this will require extensive additional work in terms of Phase III programs and resourcing that and actually executing that in a timely manner is, is the last point that I wanted to make in this time here. We have also, in the earlier presentations, talked about the opportunities for Vodobatinib beyond Parkinson's disease, and that would require, you know, additional preclinical and clinical work, and we are in the process of doing some of that. These are mainly in two buckets, the diseases which are driven by alpha-synuclein, like Lewy body dementia. And I say, you may know that we have an investigator-initiated trial going on-
Excuse me, sir, I'm sorry to interrupt. Sir, can you speak little bit louder, please?
Sure.
Little bit louder.
Sure.
Thank you.
Sure. So I was talking about additional indications for Vodobatinib, which will require additional preclinical studies and clinical studies, and some of those studies are currently underway. You may know that we have been working with Georgetown in an investigator-initiated trial to explore this program in a smaller proof of concept study for Lewy body dementia. We are also working in early stage preclinical work in Alzheimer's disease with this mechanism, with academic investigators. So there is additional work that needs to be done to fully explore the potential of this program in other indications and other diseases, but also in other settings in Parkinson's. If you look at the design of Vodobatinib's PROSEEK trial, we are looking at early-stage Parkinson's patients who are pre-symptomatic therapies.
Those are patients who are in a very early in their disease process and before they get into symptomatic therapies like L-DOPA. So if you bring, if you demonstrate disease modification or bending of the neurodegenerative arc in this setting, clearly there is justification for exploring this program in other settings in Parkinson's disease. It's like late-stage disease with the companion for symptomatic therapy and also precursor conditions. So in all these settings, that will require, you know, additional studies. So a success on PROSEEK would be the beginning of an extensive journey, which would then validate the program in the early setting, which would be our first registrational program, but also it will initiate a significant number of opportunities outside, but all of that would require an additional investment and additional exploration from a preclinical and clinical standpoint. That takes me to my last slide.
I just wanted to highlight a few market-related risks here in this slide. We have seen, you know, recent coverage on Vodobatinib, which in our view, captured some aspects of the program, not all aspects of the program comprehensively. So for investors who intend to price in Vodobatinib's potential to their decisions and deliberate analysis of the potential of the program, both from a sales standpoint and also extension into other possibilities standpoint, along with an understanding of cost and risk and also time to market, it's important before you take those calls. And this is, I mean, in a setting like this, when early-stage biotechs go into data events like this, there is significant risk of price volatility.
And that is, you know, somewhat magnified in the market like in, the absence of informed analyst coverage, which, looks at these programs carefully. So when you look at, this reporting that is coming in, we urge you to take a balanced, view on the program, which balances both the potential of the program as well as the risks of the program. And finally, you know, I want to reaffirm our commitment to this area. We are going to see significant data coming from this program, in the rest of this year, and both the interim analysis and also in the final analysis. That's going to teach us a lot about, the c-Abl role in neurodegeneration. It's going to teach us about how moderation of stress pathway is going to have a role in, treating neurodegenerative diseases.
There is a significant number of possibilities in these data events. You can have a clear validation of this hypothesis. You can also have a clear debunking of this hypothesis, but there's also a lot of gray space in between. So this data, you know, we are looking forward to contextualizing what we have learned, and then finding ways to move forward with continuing exploration of this program. And not just in, you know, this area, I think, this hypothesis. We also want to reaffirm our commitment to neurodegenerative diseases. In fact, if you go back several years, you know, that was a bet that we have taken, that neurodegeneration, in spite of conventional wisdom, going the other way.
We believe that neurodegeneration is an area is maturing from a science standpoint, and that has also been validated recently with several transactions happening in this space. So we will continue to be interested and continue to be excited about making a dent on these difficult diseases in the neurodegenerative spectrum. So with that, I will conclude my comments and open up this call for questions that you may have. Thank you very much again for attending this call on short notice.
Thank you very much, sir. We will now begin the Q&A session. Anyone who wishes to ask questions may please press star and one on their touchtone phone. If you wish to withdraw yourself from the question queue, you may press star and two. Participants are requested to use only handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. We'll take the first question from the line of Ketan Gandhi from Gandhi Securities. Please go ahead.
Hi, sir. In the November 2nd presentation, you indicated on Slide 19 that approximately 87% of the eligible patients enrolled in part II from part I. In the current, however, in current presentation, there is no update. Do you have any update on that, sir?
No, we have. That is true sir, 85%-87% of the eligible patients, and patients who are completing, part I of the study and eligible for continuation into phase and the long-term extension study, is enrolling in the long-term extension study. We don't have additional data. That trend continues.
Yeah. And, sir, do you interpret the rollover rate to part II as indicative of patients positively embracing the treatment? Or is it possibly as a result of patients not experiencing the desired improvement? What is your thought process on that?
It's very difficult to conclusively say that, because, you know, we have patients, on a significant number of patients on placebo. They may also want to have, even if they are not, improving, they may want to, you know, access the, track in the long-term extension study. So there are a lot of motivations, right? Patients are feeling better, and they may want to continue. Patients feel that they're not feeling better, but they may be on placebo, and, and they may want to transition to track. So there are a significant number of, different motivations that may be driving that, conclusion. So while it may be, you know, encouraging, you know, it's difficult to draw any definitive conclusions based on that.
Sure, sir. On, sir, Slide 5, under the section expanding evaluation of Vodobatinib, it is mentioned that SPARC would explore initial registration in an early treatment and life setting. Can you throw some light on regulatory pathway post the announcement of PROSEEK top line data in August 2024? Whether we would go for regulatory approval for, or we would go after Phase III. Can FDA help us in getting approval post EOP2?
So first, let me give you a little bit of context to this statement in this presentation, which is, we will be exploring initial registration in early treatment life setting. And that is the most, you know, logical way to plan a registration like for this program, given the evidence that we are likely to see from PROSEEK. The patients who are coming into PROSEEK are early-stage patients who are treatment naive from a L-DOPA and symptomatic standpoint. So if you're getting a positive readout from that trial, the least risk option from a registration standpoint is to repeat those studies and introduce those results, which will become the basis of registration.
So the intent of that statement is that the early or the initial registrational setting would be a repeat of what we have explored and studied in PROSEEK. Now, the second part of your question, in terms of what would be an actual registration program and regulatory ask, that is subject to the discussions that we need to have with regulatory agencies. We are going to have in-depth conversation as soon as we have data, and there are very many possibilities. I mean, traditionally, the agencies will require 2 additional Phase III studies, and that's the classical ask in this kind of setting. But there are also other possibilities of, like, factoring in PROSEEK into a registration package in some form or fashion.
But that is all strategies that would require validation and agreement with agencies around the world, and we can do that as soon as we have data from the PROSEEK program.
Sure.
So final shape on the registration package can only be clear after we have these discussions with the agency.
Sure, sir. If I may, squeeze one more question. Is my understanding right, that we will be starting partnership program, as soon as between interim data analysis and top line data, between that period?
That is true, yeah. We expect to initiate conversations with potential partners. We may not be able to conclude that before a final data disclosure in August, September, but we intend to kind of use this time to engage and create interest and work towards a partnership as we kind of get to September.
Thank you so much, and all the best, sir, for our results.
Thank you.
Thank you.
Thank you. Participants who wishes to ask questions, may please press Star followed by one. We'll take the next question from the line of Ishita Jain from Ashika Stock Broking. Please go ahead.
Hi, am I audible?
Yes, ma'am. Please proceed.
Yes.
Hi, Anil. Thanks for the update. I appreciate this reiteration of the risks associated to drug development. My first question is: so our enrollment concluded in October 2023, was the enrollment timeline as anticipated, or did we face any challenges in recruiting?
Your voice is a bit muffled. I couldn't hear you clearly.
Sorry, is that better?
Yeah.
Okay. So my question is that, you know, our enrollment concluded in October 2023. Was the enrollment timeline as anticipated, or did we face any challenges in recruiting?
Uh-huh. So if you remember, Ishita, we started this program, even though technically in 2019, and, with actual doses, we started the program in the early part of 2020. Exactly when, health systems around the world started shutting down because of the pandemic. So the first year, the initial couple of years have been rough for the program because, most of the hospitals were not seeing patients in person in hospital settings, and many of our, endpoints require, practitioners with assistant outside. So in that sense, you know, we clearly have seen slower than anticipated recruitment in the first part of the study. But it has clearly picked up, in the last 18 months or so, which helped us, you know, conclude this program, almost in line with the revised timelines.
We did a revision of the timeline during the COVID phase, so that COVID-induced certain delays, but other than that, in the last 18 months to 2 years, the program has been tracking to the plan.
Understood. So, what I'm trying to understand is that if we go into, let's say Phase III, I mean, Phase III in terms of size and then enrollment concerns in Phase III, I mean, is that significant? I mean, obviously notwithstanding existing drug development concerns.
Look, I won't be able to comment on the actual size of the Phase III program. There are significant number of statistical considerations that will go into defining that size, and it will also be informed by the data that we are seeing in PROSEEK, right? In terms of the doses that are effective, what is, registration dose that we want to carry and the effect size that we are seeing, in the Phase II setting. So there are a lot of variables which can only be informed by data from the PROSEEK trial. So it won't be, you know, I won't be able to clearly indicate the size of the Phase III program....
But we, you know, expect to maintain the momentum that we've had in the later part of PROSEEK in terms of recruitment going into the Phase II program. And because we have, you know, built relationships with investigators across and other service providers in this ecosystem, and we understand this space probably better than we started off. So I think, you know, we are confident that we can maintain the momentum that we had in the H2 of this trial from an actual recruitment rate standpoint. But actual size of the program in terms of the number of patients that we require is a function of where we land with PROSEEK, and it would be difficult to extrapolate that now.
Makes sense. I think, I'm not sure if you already mentioned it, and did I miss it, but, meeting with the agency would only be post final data, right? There would be no agency meeting, with interim data.
Yes. Yeah. The agencies would require, you know, completion of the trial and data from the ITT population before we can have an end of Phase II meeting.
Okay. If I may just ask one more. You mentioned that we may require additional preclinical studies. What kind of studies would these be? I mean, I know it would be around efficacy, concentration of drug in the brain, or, I mean, checking for specific biomarker. What kind of additional preclinical studies would be required?
There are several, you know, toxicity studies which are expectations, from, you know, standard expectations in the registration package. To give you an example, pharmacogenomic studies, for example. It is a standard expectation in the registration package. There may be additional clinical trials, like, you know, drug-drug interaction studies or, other toxicity studies in clinical settings. There are, you know, part of customary expectations in a registrational setting, both, preclinical studies and certain additional clinical studies. They're not, clinical studies are not major clinical studies, but they are, you know, you know, PK studies or studies which, explore safety endpoints.
Got it. Thanks.
Thank you.
Thank you.
Participants who wish to ask questions, may please press star and one on their touchtone phone. We'll take the next question from the line of Bino Pathiparampil from Elara Capital. Please go ahead.
Hi. Good evening. Thanks for taking my question. Could you please make some comments around the IP estate around Vodobatinib? Do you have a drug substance patent, and till how long does it run, et cetera?
So, I don't have the exact dates in front of me, but I can indicate the ranges. The, with competition and matter and the regulatory compensation for the development time, you know, we will go into late H2 of thirties from an IP coverage standpoint. And we may also have some additional, you know, patents which are covered in this space, with the method of treatment patents and also potential formulation patents. So, you know, we are confident that we may go into late H2 of nineteen thirties, so nineteen thirties, I mean, twenty thirties, for sure.
Got it. Thank you very much.
Thank you. A reminder to all the participants, anyone who wishes to ask questions, may please press star and one on their touchtone phone. Ladies and gentlemen, as there are no further questions, I would now like to hand the conference over to the management for their closing. Sir, can we take one question, as I can see one participant right now joined in the conference? We'll take the question from the line of Tushar Bohra from MK Ventures. Please go ahead.
Yeah, thanks for the opportunity. That's Tushar Bohra from MK Ventures.
Thank you, sir.
Yeah. Am I audible?
Yes.
Yes, sir.
Yeah. So just, a couple of points. So while, the, you know, the end of Phase II discussions with the FDA would happen only after the final data, but, fair to assume that the interim data analysis, whatever the, readouts that we would have, the same would be shared with FDA as well? And that may be, useful in, in, whenever we have the final discussions, this would be something like a pre-read or a, you know, an advance, discussion item, that is shared with them.
We do not have current plans to share the interim analysis outlook, I mean, the data, with the agency. Our next planned interaction with the agency on PROSEEK data will be post full data disclosure in September of 2023.
... Okay. And, in the November interaction, you had mentioned regards to my question only, about, two or three drugs, especially in the case of Alzheimer's, where FDA has shown inclination for an, you know, a faster registration pathway. Is it fair to assume that a similar pathway is potentially one of the options for SPARC as well, as in PROSEEK trial is large enough and pivotal enough, that FDA may, in one of these situations, have that as an option, that this can itself be used as a registrational study?
Yeah, that is, if I answer that, it would be speculative, because it require agreement with the agencies. But I want to highlight a couple of points. We have a significant number of endpoints in PROSEEK, both clinical endpoints and biomarker endpoints. The possibility of an accelerated approval would require significant intensive, how the data comes in, and where all the chips fall. Especially, I mean, if you look at the precedents in Alzheimer's or ALS recently, they have used a conditional approval pathway, which was based on validated biomarkers in those space, those areas. So Alzheimer's and ALS. Alzheimer's, because of the AD data traces, and AD data because of the validation of neuronal death marker called neurofilament light, had significantly more clarity in terms of the correlation of these biomarkers with clinical outcome.
So we may see, you know, similar trends and similar correlation in PROSEEK, but in the field at the moment, we don't have validated markers like Alzheimer's, Alzheimer's had going into those events. So in that sense, there are some challenges inherent in the indication, which kind of differentiates this with AD or ALS setting, but there may be possibility, then. I think it is highly speculative from our part to indicate that as a possibility at this point. It's a function of what we see in the trial and also how the regulatory agencies interpret that.
Fair enough, sir. And at different points, you know, in previous discussions, it has been mentioned, at one point, we—I think we mentioned that, there is a backup compound to Vodobatinib, that we are looking at, you know, potentially for Alzheimer's as well. And I think in a previous discussion in November, so it's highlighted that, you know, Vodobatinib can also work for Alzheimer's, the alpha-synuclein pathway, if I get that right. So, which one is it? It's maybe a bit early, but just to understand the thought process, whether it is Vodobatinib itself that we may look for Alzheimer's also at some point, or is there another compound, maybe similar, you know, similar domain that we may look for Alzheimer's?
Yeah. I think if we continue to see preclinical data coming in expected lines, we think Vodobatinib can be explored in Alzheimer's disease because of its activity in alpha-synuclein. But in mechanistic studies, I mean, mechanistic studies in vitro, in iPSC-derived neuronal cells, we have seen proteins like activated or phospho-Tau or A beta 40 and 42 moving in a positive direction with Vodobatinib. So this mechanism of c-Abl inhibition may have legs in diseases which are driven by other proteins other than alpha-synuclein, and that is a key part of the data that we have already presented and disclosed. And that is what gives us confidence to look at these other indications, like A beta, I mean, A beta driven diseases or ALS.
But from an actual development standpoint, strategy standpoint, we have spoken about this in the past, we may probably... I mean, we have a backup program for Vodobatinib. There are additional assets in that package, and we may develop an additional compound, backup compound. This will give us a longer IP life from a competition and matters standpoint for additional indications. So we may choose to develop a backup compound in all clinical indications driven by other proteins.
Got it, sir. One last on the Parkinson's, you know, beyond PROSEEK. So, how prepared are we for... Assuming that we need to do a Phase III trial, how prepared are we for launching the trial? I mean, typically, you know, Phase II to Phase II, there is, you know, a decent lag in a number of programs because of lack of preparedness on the trial design or, you know, regulatory clarity or even funding clarity, for that matter. Assuming we have a very strong positive data on PROSEEK, and we are required another trial, how well prepared are we? Have you already started working in that direction, sir?
So there are, you know, different—I mean, there are multiple compounds, so we have questions. If you look at various... different variables of preparedness from a late-stage setting. One is, you know, what to do in terms of regulatory and scientific clarity about the nature of our registration trial or regulatory program that we want to have, and activities that we need to obtain that clarity, and then the ability to kind of design a trial according to those expectations and execute that. And then there is a competency and scale-related aspect, which is substantial in our Phase II to Phase III transition, because kind of competencies that are required and the scale that you're requiring in Phase III setting may be somewhat different from what a trial or Phase II program.
Then, as you rightly pointed out, the resourcing expectation is significantly more than the Phase III sample, because you may need to conduct multiple global trials to complete the traditional Phase III package. So on all these counts, we may we want to move at risk in the next few months, and we just already started working on some of these aspects, thinking about what could be the nature of the Phase III program from a science standpoint, and also try to put together a sense of the capability gaps that we want to bridge, and also, you know, the extent of resourcing that is required.
So we are actually doing some of that, those regulatory activities at risk, but you can only get full steam, once we have clarity from PROSEEK, both from a data standpoint, and also it gives us an ability to discuss this more openly and transparently with other players that we need to discuss this with, for example, for resourcing. So it's a nuanced answer. Yes, to the extent that it's possible now, but we are extremely aware of the extent of work that needs to be done, and it will all get in full swing post-data in September.
So even in the eventuality that, you know, two outcomes, one, where unfortunately, let's say we don't get the relevant data outcome in PROSEEK, and two, where we have a very strong outcome and yet, and the trial goes through well, and maybe we go through to a registrational study. In both these situations also, in any case, you will do a trial for Vodobatinib for a symptomatic setting, right? In combination with L-DOPA and the existing regimen. So that part, in any case, you would be already maybe working on some kind of a trial setting, which is something that you would any which way do?
No, no, no. So let's look at the spectrum of possibilities that can come from the PROSEEK trial. On the positive side, we can have a full validation of the hypothesis and data in line with the design expectations of the trial. On the other end, we can have a full rejection of the hypothesis in the sense that, you know, the going assumption about this mechanism, and the mechanism producing a certain level of difference on the trajectory of neurodegeneration was not correct. So there can be a rejection of the hypothesis, and there can be a host of possibilities in between. That is, it is working in patients with a certain difficulty or it is working with patients who may have mild being individual with background disease.
So there are a lot of other possibilities in terms of that gray area between a full rejection and a full validation, right? So the question was pertaining to the full rejection of the hypothesis, if I understand it rightly. In that case, we don't believe that there is a justification for exploring this program further in any setting, because it, it's a bit, you know, it rejects the primary mechanistic hypothesis. But in all the other possibilities, whether it is a full validation or validation in parts in different settings, that difficult gray area, we think there are possibilities to move forward with an appropriate registration package.
Got it. No, I was just wondering that if the trial is successful as well, then, as you said, that we would look at Vodobatinib for, you know, the extension of the entire Parkinson's program. So that part, in any case, you would already be working on, right?
Yeah.
That's-
If the program is successful, if Vodobatinib is proving is validating the c-Abl hypothesis in PROSEEK, then there is justification in extending this to other settings in Parkinson's disease. Because if it is slowing down the trajectory of the disease, then it can be a companion for L-DOPA and slow down late stage disease, or you can think about exploring this in a precursor condition. But if it is not slowing down, then there is no basis. That's the point I was trying to make.
But if it is slowing down or if it is having some reaction, but maybe not sufficient enough, to you know, to meet the trial design, in that case, is there still a scope or a reason to study it in symptomatic setting?
We have to take a close look at the data at that point. What you're indicating is that you're seeing a trend, but you may not be meeting statistical significance because the trend is not as strong as we initially thought.... We have to take a close look at that trend and, and take a call based on the data that we are seeing. But that is a possibility. I, I don't want to reject that possibility.
Fair enough, sir. Sure. Thank you so much. Wish you all the best.
Thank you.
Thank you.
Thank you very much.
The next question is from the line of Jigar Walia from OHM Group. Please go ahead.
Yeah, good evening, and thank you so much for this call and the opportunity. Sir, if you can help understand the administrative interim approach versus the full interim, and might you still maintain that there might be a requirement for a proper Phase III, and, you know, would certainly go with a partner approach? You know, there would be challenges in terms of seeking getting leeway on the Phase III. So, we want to understand with regards to the administrative, and is there a possibility that a slight possibility that it may be talked for a Phase IV direct, so wherein a full phase this thing happens, but post-approval?
Right. So the difference between the interim analysis or administrative interim analysis and the full data set is the number of patients who are going into the analysis. We have, you know, 441 patients going into the interim analysis in end of March, early April, and 513 patients going into the full data set, which would happen in September of next year, early September next year. So it's essentially we will have practically all of the clinical endpoints and many of the biomarker endpoints in the interim analysis, but not all. Some biomarker endpoints would require, you know, additional time in terms of both validating the method and also getting it done.
So we will have all endpoints, the primary endpoints, all the secondary endpoints, and all the biomarker endpoints as part of the final readout in September. While we may have a subset of... a substantial subset of that in the interim analysis. But substantively, that- those are the two differences, the number of patients and also the extent of data from endpoints standpoint. The second part of your question is, you know, tricky, and we can... I don't want to get into a, a speculative development. There are possibilities in terms of nature of registrational expectations from different agencies, but, you know, me giving a guidance in terms of what is possible at this point is dangerous in the sense that, you know, it is subject to significant change based on data and how the regulatory agencies interpret that data.
I would refrain from taking a position in terms of what could be a possible registration pathway till we have those discussions with the agency.
Yes, sir. Sir, there is since the additional patient subtypes now would require additional investment time if you set up. So, if you can help understand the partnership approach, would it be only for the Parkinson's disease, PD right now, or would it also try to cover the additional subtypes?
Yeah. So we are getting into this partnership process with a certain level of openness in terms of the kind of partnerships that we want to have. We would like to have a relationship which maintains some level of participation in both development and also commercialization of this program, plus some flexibility in terms of additional indications we retain within SPA. But at the same time, you know, these discussions, you know, can take a life of its own once you, you know, get into them. So in that sense, we are open-minded in terms of approaching our partnership strategy. Our baseline expectation is that we will continue to retain our role in some level of role in development and commercialization.
But the natural nature of partnership would be a function of, you know, what we are going to see in this process. But you know, we will explore that fully post the interim analysis data in March.
Got it, sir. Sir, to understand, since the partnership is gonna be for the PD perspective, et cetera, would you be looking at funding for any other programs? Or, I mean, only this would be a priority until this is settled. So, you also have the fundraise approval, et cetera, those in place, apart from the partnership approach you could get.
Right. So I don't want to, you know, draw a hard line and say my partnership would only be for Parkinson's disease. In fact, one of the objectives for partnership or one of the drivers for seeking a partner is to expand this program aggressively. So in that sense, we would like to leverage both the resources and also competency market of a part, larger partner fully exploring this program in Parkinson's and also in other indications. But how we actually carve out those different spaces in terms of ownership and extent of dilution is a function of these discussions. So we don't have a set view that the partnership is only going to be for a limited part, phase setting, and SPARC will continue to resource everything else. That's not the intent, at least, going into this trust.
Right. So just a hypothetical listing that, what probably in case of a negative outcome, does it remain open to pursue the CML indication, given that this would be-
Yes.
Only, yeah.
Yeah. We already have clinical proof of concept for CML, and it would require an additional study, and we have some clarity in terms of what that study is. And then we have to take a decision whether SPARC will just, you know, invest additional resources into conducting those trials or whether we need to seek a partner to do that. That's a call that we can take once we have clarity on the data.
Got it. Thank you very much, sir, and congratulations on this, sir.
Thank you so much.
Thank you. The next question is from the line of Bino Pathiparampil from Elara Capital. Please go ahead.
Hi. Thanks for the additional question. You know, if you're not going to share the interim administrative interim analysis with pretty much anybody, like you said, what is the purpose of this administrative interim analysis?
The question that you just asked, you know, we spoke about the partnership strategy, and one of the key objectives of the interim analysis is to engage with potential partners early on, so that we can try and minimize the time that we require post the full data, in September. So it is not correct that we are not sharing this with anybody. We will share this with potential partners under CDA and appropriate safeguards with a limited number of potential partners. That's the expectation at this point.
Oh, got it. Thank you.
Thank you. Ladies and gentlemen, that was the last question of our Q&A session. I would now like to hand the conference over to the management for their closing remarks. Over to you, sir.
Thank you.
Thank you, everyone. Thank you for taking out time for today's discussion. We now end the call. In case you have any follow-on questions, you can reach out to us on the email and the numbers provided on our website. Thank you again. Have a nice weekend.
Thank you very much, sir.
Thank you, everybody.
Thank you, sir. Ladies and gentlemen, on behalf of SPARC, that concludes this conference. We thank you for joining us, and you may now disconnect your lines. Thank you.