Quarter have passed, and iLab Therapeutics have reported for the Q2 in 2023. In this live broadcast, viewers can ask their questions in the live chat. So to present the Q2, I I'm happy to present to you CEO, Gunnar Olsson EVP and Head Of R and D, Mr. Nicholas Waters and CFO, Victor Sievert. So please go ahead.
Thank you. Good morning, and welcome to this quarterly update. The agenda for today is that I will give you news from the period. This will be followed by Niklas to give us an R and D update. Then Victor will follow to give us an update on the financials.
We will then conclude and open up the question and answer session. Operational highlights during the Q2. For Mr. Opejarn, in May, a discussion was initiated between could be available for patients with Parkinson's disease. For 757-942, in May, Eelaben Macquade Center For Strategic Research and Development, we made An agreement that gives MSRD the rights to evaluate 2 of Irlab's Projects, the neuropsychiatric programs for 757 and 942.
And the purpose here that is to investigate if there is a possibility to come to a collaboration agreement to develop the compounds from where they are now up to clinical proof of concept. GripMat, at the end of May, IRlab announced that all of the 38 clinics in the study were up and running and are now recruiting patients into the IBAGS conference in Stockholm around the ISP. We shared new information about the usefulness and the uniqueness of our ISP platform for drug discovery purposes. AGM. June 20, we had the annual AGM.
And at this AGM, the Board was extended with 3 New members, Veronika Wallin, Christian Noche and Daniel Jonsson. Investigate sorry, investor meetings were presented at several national investor conferences arranged by ABG and Redeye, and we've had ongoing discussions with both national and international investors to provide Updates on the company. Things that have happened after the period for PiripMat, In mid July, the Independent Safety and Data Monitoring Board had their first pre planned review of data. This review was triggered by the first 25 patients that had gone through all bits of the study. The DSMB unanimously recommended the company to continue the study according to the present study protocol.
For ISP, we participated in an international competition focusing on How to apply machine learning to describe animal behavior, something that is very important to us since Our preclinical experiments are built on animal experimentation to see effect on animal behavior. The competition was arranged by a consortium of neuroscientists from the Northwestern and Caltech Universities. ILA was awarded the 2nd place in this competition, And I think that this very well demonstrates the very high sophistication, the frontline Position we have in using machine learning in our discovery and development activities. The Proceeds from this competition has been published. As you see on this slide, there is the link to the Publication.
For Maestopperdam, on August 21st, IRLab secured The ownership and all rights to the Phase 3 were the best orbital project. And that means that Ehrlab is now in control of further clinical development as well as conversation of the product. On the 22nd August, Ilhab gave an update of the mestopram project, and that included Additional data from the Phase 2b study in Lids, and it also included data from the 3 Phase 1 studies performed by Ipsen. All in all, the data show that best orbital has Showing anti dyskinetic efficacy. It has an anti Parkinsonian effect without compromising normal motor function.
And it has a safety and tolerability profile that was on par with placebo. And that means that our judgment is that now, Mr. Opran, we need to prepare for an end of Phase 2 meeting with the FDA in order to define the Phase III program. On August 28, Results from the Phase 2b study with Mr. Oppedham was presented at the MDS Congress in Copenhagen.
Financial highlights for the quarter. Net revenue, almost SEK 7,000,000 total operating expenses, almost SEK 52,000,000 Operating results, minus SEK 45,000,000 cash flow, minus SEK 53,000,000 Cash at the end of the period, euros 156,000,000 total number of registered shares, close to 52,000,000, the same number as at the last quarterly update. So EarLab Having now a world leading portfolio of compounds to improve Parkinson's treatments. We are building on pioneering biology, biology and knowledge Stemming from the research team around the Nobel Laureate, Arvid Carlsson. From that, the development of the ISP, The platform to generate new candidate drug molecules.
We have a focused strategy based on the deep knowledge about Parkinson Biology, we have validated business model based on clinical proof of concept. So we've taken molecules from discovery up to Phase 1, Phase 2 and now being Phase 3 ready, and we have had deal making experience. We have a broad and solid portfolio where all the different Stages of the Parkinson disease are addressed and every molecule having the potential to be a blockbuster. We have an organization positioned for success. So now a little bit about Park is on to Set the scene how we see the disease and how our molecules fit in.
So what happens when you get Parkinson's disease? Well, it is well, more than 50% of your cells in the brain producing dopamine has died off. Why is this so important? Well, dopamine is one of the absolutely most important signal substances engaged in a number of different functionalities of the brain. Why does it happen?
In a small proportion, it is of genetic ill background. And in the most or if I say, in the majority of cases, It is environmental factors. Hallmark symptoms, the characteristics that is the tremor, It is the bradykinecia with slow movements, and it is rigidity. If you try to bend an arm, it will be very rigid. There are other symptoms and maybe one of the most important one being postural instability.
But the key take home message that is Parkinson's disease is a chronic one and it is progressive. And that means that this is lifelong and it worsens over time. What are the key problems for the individual patient? Well, different surveys have approached Patients to ask, what is it that is bothering you? And here is one of the largest surveys.
And as you said, the most Frequent bothersome symptoms, that is balance and instability leading to falls, the hallmark symptoms of tremor, rigidity, Branded kinesia, impairment of cognition and mood changes like apathy, anxiety and others. The important thing here is that our projects, they align with these areas. And we can see that on this slide, if we look to the right, you see the impaired balance and falls, Pirapmab, hallmark symptoms are 11.17 cognitive decline, Pirapmab942 mood changes, mestopetum 757, 942 And the motor complications seen with chronic levodopa treatment, bestopetad. To the left, you see estimation of about 6,000,000 diagnosed patients in the major markets. And you see that in the next 15 to 20 years, this will be more than doubled.
So it is a growing Medical unmet need. Here is just to illustrate The ISP, the unique platform for identifying new drugs. We are using a computer based advanced Systems biology technology to discover the new molecules. And if you look at the right, you see A three-dimensional picture rotating. And every dot is a molecule.
And then on the different axis, we could apply different characterizations of things we want to see with the molecule. This is just for simplicity. In our computer modeling, we are simulating with up to 600, 700 dimensions to really see that a molecule brings what we wanted to bring. And all in all, this results in 1st in class medicines because it's really innovation. And that in terms generates very strong IP position.
The important thing for us is that already at the time when we select a new molecule, we see where we have the largest potential. We are guided on where to go. Maybe the most important thing that is that this gives Higher probability of success to reach late clinical development when we compare to industry standard, which is using the target generated strategy for screening. So this is Our engine of creating our innovative molecules. With the ISP, we have built this portfolio.
And I said, my view, this is the world leading portfolio. West Oppen, our lead or most advanced project, Now have finalized the Phase 2b study and the next major event, that is the end of Phase 2 meeting with the FDA To outline a Phase 3 program for treatment of lids. Piretimab, our compound to prevent Falls in Parkinson's disease. We're now running the Phase 2b study, and we hope to see The results coming out first half next year. 757, our drug for apathy, We are now working in the preclinical field, and we hope to have the project Phase 1 ready by the end of the year.
The 942, our treatment for cognitive impairment, preclinical development, we hope To see this one being Phase 1 ready by first half next year. And eleven-seventeen, Our treatment for the hallmark symptoms, but without all the complications we see with chronic levodopa treatment, We hope to see this one being face ready during next year. And a product with the profile that we see for 11.17, It has actually the potential to replace Leerodopa in the future. Something about now how Parkinson's disease evolves over the lifetime of the patient and how our Products fits. Here you see a slide of a graphical slide of how the development of Parkinson's disease, at time 0.0 at the middle of the plateau, that's when the symptoms Occur and the diagnosis is defined.
Then you see over time increasing symptoms. And where we are focusing, that is on the psychiatric symptoms and the motor symptoms. And how do the projects FIT. Talking about mestopetan, you see here in gray boxes where we see that Topbottom will provide some benefit. We then go to PirapMat.
We see other gray boxes Filling up and this is where Pirapimat will be able to help. Then 757, yet another box, €942,000,000 The €1117,000,000 And then the important thing, that is to see how What is the picture looking like when we take them all together? As you see, with the portfolio that we have And that we are working with presently, we will be able to provide beneficial effects to patients throughout their Journey of the disease in the great majority of symptoms and complications, and that makes us excited about our portfolio. So with this, I think it's time to now leave over to Nicolas, who will give you some more detailed update on the R and D side. So please, Nicolas?
Thank you, Gunnar, and thank you, everyone, out there for listening in today. I will rapidly continue with some updates on Mestopetam, we have seen in the past quarter and during the summer. Mestopetam It's a totally novel molecule with a novel mechanism of action. As Gunnar mentioned, this is a first in class product. It has potential in treating motor complications in Parkinson's disease such as LIDS.
But also previously, we have published data indicating that we also perhaps can prevent the occurrence of liver dopa induced dyskinesias. It has potential in psychosis and also in other indications. During the Development of mestopetam, we have now created a quite large body of evidence which supports the novel treatment for dyskinesia in PD. And this started many years ago, I would say many, but some years ago, with Phase I studies. We added then a Phase Ib study in Parkinson patients where we looked at safety tolerability but also at efficacy, Gain the efficacy signals in that study, plus increased understanding of the pharmacokinetic properties in the population.
Then we ran a larger Phase IIa study, also safety, tolerability, but efficacy was measured using different instruments. And throughout these initial studies, we learned a lot about the usefulness of the different scales, the usefulness of mestopotom as a treatment in this population. We decided to start a Phase IIb study, which has now been concluded, and we presented some data earlier last week and also at Movement to Solar Society meeting in Copenhagen on Monday. And With this package, we believe that we now have sufficient documentation around the safety, tolerability, but also estimations of efficacy on the compound so that we can move towards pivotal studies. That, of course, needs, but we prefer to have a end of Phase II discussion with the FDA before we enter into that program.
It's fair to also mention that there are other indications possible for mestoplatam. Having a drug with the profile that we've seen in this quite severe neurological population of Parkinson patients, It's clear that expansion into other types of indications is possible. And of course, PD Psychosis is one life cycle management option. We also have LIDS prevention, which is an interesting and challenging prospect in terms of clinical trials. But then we also have tardive dyskinesia, which is, to some extent, driven by the same mechanisms as Lids.
So therefore, we believe there is a fit for Mesto Putnam in that indication as well. One thing that's important to mention here is that during the Collaboration with Ipsen in the past 2 years, they have been extremely diligent in pursuing certain aspects of the development of Mastopetan. And these are studies which are necessary to have when you file for a Phase III application. And these are Phase I studies looking at primarily the pharmacokinetics of a compound. And that means the absorption, the distribution and excretion of the compound.
And one does so in different genetic populations, such as Asians, non Asians, African Americans, etcetera. And then we've looked at the possibility of mestopotom interacting with other drugs and Changing the profile of mestobuderm or the other drug actually, and there we see no risks. And then a mass balance, that's the study where you look at where all of the compound goes and how long it takes before it leaves the body as in total. The implication of these results are really important for the further development of the compound. We have predictable pharmacokinetics.
There is no difference between the different populations we've studied. The genetics have no impact on the different genetics have no impact on the or very little impact on the pharmacokinetic profile. We expect that we would have a simple and uniform dosing, 1 pill twice daily that will help the patients. So there is low risk of dosing errors. There is no complicated dosing strategies with this.
There will be no complicated dosing strategies with mestopeton. And the data above all that enables use in a larger and genetically diverse population. So now we do not have to have restrictions in the inclusion criteria in further studies and or on the market depending on the based on the data we generated so far. And that's a really, really important part of development to establish such data. Jumping directly into the end of the Phase 2b study, we presented top line results in January.
And since then, we've been working with the analysis. We presented now last week further information on the results of the study and also on a poster present That Movement Disorder Society, which is referenced here. And for you out there, you can find the poster on our webpage under the publication page. What we discovered and here's just a snapshot of the data, I'll have to say that. What we found in our conclusions from this study is that we have consistent dose response And what is very important, clinically meaningful antidiskinetic efficacy.
And this is something we've seen in Phase Ib, Phase 2a and now also in Phase 2b, clinically meaningful antidoskinetic efficacy. And that is measured by different scales. And in our case, we see A very profound effect on the Unified Dyskinesia Rating Scale, which is the preferred scale with regulators in terms of primary endpoints, etcetera, in studies like this. And then we see improvement in good on time. In addition, we saw profile of mestopitan.
This is a typical effect with anti Parkinsonian drugs. We don't see any side effects which differ from placebo. We don't have any Safety aspects which differ from placebo. So we can achieve a full antidyskinetic effect according to the dose response we have established without compromising motor function or adding any problems for the patients. Predictable plasma exposure, as I said, linear and dose dependent.
And then we have also been managed to now select a dose for further investigation in pivotal trials. And that is we have basically ticked off all the important aspects to move to the next level of development. So next step will be an End of Phase II meeting with the FDA, and that means that we need to build a briefing book to provide the FDA or any other regulator around the world, by the way. And that we will do in collaboration with experienced regulatory and clinical advisers, people that have done this many times before with the specific objective of Parkinson's treatments. We will have support from Ipsen, as stated in the press Releases we've provided during the peak period, and this is all to define the final protocol for a Phase 3 program.
Another aspect of the work that we need to do now is to capitalize on the results to ensure the financing for the Phase III program. Going back to or forward to Pirrip Maarten, I should This is also a 1st in class molecule, and this is in development now to improve balance and reduce the risk Falls in Parkinson's disease. Falls is one of the biggest problems, as also Gunnar mentioned, looking at the Polls out there, this is one of the biggest problems that the patients themselves report, the balance and the false complications. And about 50% of all Parkinson's patients falls recurrently globally. The cost of a fall is quite significant, around $30,000 according to U.
S. Costs, and there is no available treatment at present. So this is a large unmet need. With Pirapivat, we started the Phase IIb study last year in the early in quarter 1. And as Gunnar mentioned, we have now all centers ongoing We are recruiting across Europe in this trial, and we expect or plan to have all the patients enrolled by the end of the year and to have data to present during the spring of next year or H1.
As I said, this is a 1st in class molecule as well. It is a Novel mechanism to activate certain circuitries in the cortex of the brain. It has a Quite substantial potential in terms of both commercial and treatment. Going to the regulatory side. We have Achieved regulatory approval for the Phase 2b study across 6 countries in Europe.
We have been advised by the FDA to front load our development plan with a number of studies, which we have now done, and they have been successfully completed. And As for MastopoTarm, PiripMata has also been given a unique stem name by WHO, indicating this represents a new class of treatments. Also here, we have now we're building on the comprehensive package To move forward to further trials, the Phase I single ascending, multiple ascending doses looking at in healthy volunteers looking At PK safety tolerability, we went on to a tablet formulation, then did a Phase IIa study where we looked at safety tolerability in the Intended population, these are elderly patients with cognitive impairment and Parkinson's disease. This is the population that falls. And we could extract information from that trial indicating cognitive improvement, improvement in balance, promises of reduced falls.
And now we're running a trial focusing on exactly those aspects. We're looking at falls, we're looking at balance, we're looking at certain neuropsychiatric endpoints as well. And it's a 3 arm trial with about equally distributed across 2 doses of Pirpemart and placebo. 3 month treatment period, a dose de escalation period and then a follow-up up to 1 month of the patients. And as Gunnar mentioned, during the summer, the first 25 patients had gone through all of this, and we are now continuing building on further patients recruiting further patients into the trial.
A brief note on the preclinical program, 757, 942 and 1117. 757 to treat apathy, which is today an untreated indication or symptom in many neurological This goes beyond Parkinson's disease. And then 942 to restore cognitive function. This is a And then 11.17, which is what we believe could be a really, really interesting prospect moving forward. It's once daily treatment for Parkinson's, and that's something that is not out there today.
To treat the hallmark symptoms without inducing all of the complications we see today with today's levodopa treatment. And we boldly say that this could be a next generation treatment for Parkinson disease. Also mentioned previously, 757 and 942 is now being evaluated in a partly collaboration with MSRDOOROTZOKA. They're looking at the documentation we have generated so far, and we're looking into the Possibilities of building a collaboration for both of these assets. When it comes to The indication as such, this is quite huge.
There is about 10,000,000 Americans with apathy and 10,000,000 Europeans at the same time affected by apathy. And in neurological disorders, this occurs at very high frequency. This is a very well known comorbidity, but there is no really good treatment. There are a number of hypotheses on the genesis of apathy. And we are targeting on one of those, which deals with the crosstalk between different brain areas, which is hampered in people with apathy.
And we can strengthen or reverse that or improve that crosstalk with 757. And then cognitive dysfunction is quite well known in the public domain. Often one thinks about Alzheimer disease and cognitive dysfunction, but Parkinson also is a Disease with a lot of cognitive issues during the course of the development of the disorder. And in general, about 12% to 15% of all people over 65 suffer cognitive impairments. And As I said before, 942 has a very, very clear cognitive enhancing profile across different cognitive modalities, as they in preclinical studies.
And now we're bringing both of these molecules towards Phase 1. 757 will be Phase 1 ready at the end of the year, 942 during next year. And this is according to our plans and what we communicated before. And lastly, but not least, 11/17, the next generation treatment for Parkinson's disease. This can be used as a monotherapy as well as an add on to levodopa, we believe.
It has the potential to be an effective treatment without the complications we see with levodopa. This was a drug that we nominated this year, early this year, And we are now doing the preclinical exploration and development activities, hoping to reach a Phase 1 Ready State during next calendar year. I will now turn over to Victor to give a brief update on the finances.
Victor? Thank you, Niklas. Finances, most important figure is, of course, the cash position, which is about SEK 100 or was about SEK 156,000,000 at the end of Q2. There is a continued focus on cost control. The costs were about the same level as in Q1 and also the same level as in Q2 last year.
If you adjust for the cost in Q1 for the former CEO, We do expect the cost to go down a little bit towards the end of the year as important activities are closing in on being finalized. During the quarter and also during the rest of the year, we will Continue investing in the Phase 2b study with Repmalt of course. And we will also continue to invest In the preclinical development of the preclinical projects 757, 942 and 1117. As you can see in the right most graph at the bottom, the number of employees has been stable for more than a year, showing that the operations is basically ongoing at a steady pace. The analysts that cover us and are with us today is Frederick at Redeye, Gonzalo at ABG and Zu at Edison.
And we hope to get some good questions from them after the presentation. So over to you, Gunnar, to conclude. Yes.
Recapitulation, this is the portfolio. We've talked about this, so I proceed. Some words about anticipated key development milestones over the next year. Q3, Actually, what you see here to the left, we have already mentioned in what happened after the period, so I won't repeat that. But when we look into the Q4, we anticipate a second DS and P review of the Phase II study with Pirapimat, and that is, again, according to a preplanned model that we have.
We also anticipate that the Piripemat Phase IIb study We'll come to end of patient recruitment by the end of the year. As we mentioned, 757, we hope to see A Phase 1 ready project at year end. We are planning for a Capital Markets Day in Q4, And we will participate in at investor events with ABG, with Pareto, Redeye, Biostock and SEB. We will also participate in scientific congresses. For next year, first half next year, we Estimate to see perepimat Phase 2b top line results.
We estimate to see 942 coming to Phase 1 Readiness, And we will continue the 11.17 preparation aiming for Phase 1. You see here at the bottom, without And the time, location, so to say, and that is the end of Phase 2 meeting with the FDA for Mersdopetan, That is very high priority for us. But since we are not the one setting the date for such a meeting, we need to interact with the Yes. We just put it here as an event without confirmed time frame. Of course, when we know more, we will communicate.
So IRLab, a world leading portfolio Based on pioneering biology and a unique platform for drug discovery, the ISP, Focused strategy on Parkinson based on the profound understanding of Parkinson biology. Validated business model built on clinical proof of concept, broad And solid portfolio, as you've seen, and a normalization position for success. That's the end of the Formal presentation, and I think that we are now moving over to the Q and A session. So if I invite Nikolas and Victor to the table as well.
Thank you so much, Gunnar, Nikolas and Victor, for that presentation. We will soon hand over to some equity analysts. But first off, let me ask you, could you please take us through the events that led from Ipsen being your partner to where you are today?
It actually started with a phone call to me on the 1st May from Ipsen. It was clearly stated that we would like to discuss how we the best way could take the product forward so that we can Reach registration and getting a product. We have had then long discussions with Ipsen. Ipsen has clearly stated that they see that this molecule has the potential to be a product, And they want to see it come to the market. In parallel, we have understood that there have been ongoing activities in their own portfolio.
But all in all, this led to an agreement that we closed on the 21st August, Well, it's very clear that Ipsen is interested in the product. They will support us in bringing together the briefing book for the end of Phase 2 Meeting with the FDA, they will provide us with the study medication for the Phase 3 study. And they have been very clear that they don't want us to give any payment to them during the course of development activities Because all the funding should really be to move the product forward, but they are interested in getting part of the success of the product in in terms of royalties on sales. But it's good for us that the payment won't kick in until we are on the market. Then what I'm now going to say is only my pure speculation.
But being in the discussion with Ipsen, of course, I followed or we have followed what's happening within their company as well. It has been interesting to see that they have had some significant development in their own portfolio. So in mid June, they had an extended approval for a product that they Acquiring Albire by turn of the year. So it now has a much broader indication and use. Secondly, by end of June, they reported that a project that they have in license from Genfit had very positive Phase III data.
And then mid August, They reported that they had approval of a new product in the United States. And All of these projects are, of course, closer to the market compared to Maestopetan. And I don't know if it has had And the impact, but I know that having these type of successes in your portfolio, you really need to invest to bring them to success. And if this has had an impact on how the agreement Was defined in the written agreement, we don't know. But definitely, We have a clear indication that Ipsen do have an interest in West Opland even if we now secure the full ownership of the compound.
Thank you so much for sharing this, Gunnar. So now let's move on to the Equity Analyst, we will start off with Fredrik Thore at Redeye. Please go ahead.
Yes. Hello and thank you. I know it's very early, but I was wondering, do you have any insights on how you could improve the replicability of the results in a phase Free trial and especially in the good on endpoint, maybe there are some learnings in the TES group versus the FAS group, for example.
Of course. As I illustrated in the developments progression of development of Stobotham, we have learned a lot over the past few years, what to do and what not to do. And we also have learned how to sorry, how to manage the sites and instruct doctors and patients to a much higher position now than before. So with all the knowledge we have gained over the past few years, We are quite confident that we can design and conduct further trials, which will deliver what we hope they can.
Thank you. And in the FAS group, when looking at the UDSRS scale, Those dependency was less obvious than in the TS Group. Is there a good explanation for that? Could it just be out of randomness
Our variability and that's just why you do all these additional analysis on a trial data set to be able to actually define the actual or the most likely effect of a drug. And the dose response we see here, I reiterate that we've seen that also in the Phase 2a study, those responses on the important endpoints indicating that we actually have a very clear understanding of the optimal dose to be used in further trials.
If I just add here, in different phases of drug development, you put different type of emphasis On which analysis provides you with the best answer. In the dose finding, the Most important part that is really to see what does an actual dose give in terms of effects, both on the effect side as well as on the safety side. And this is why this type of recorded PS protocol analysis is so important in this stage of development. In Phase 3, that is a different thing. Then you really need to show you have an effect when you have selected the dose That you're testing.
And then you're always to the intention to treat analysis that is the FAS analysis that we showed. Because then you really need to document that giving a treatment According to certain schedule, it will deliver what you wanted to see. But going back to the Phase 2b study, the way it was Designed so that there was the possibility of those adjusting early in the study, it was very important for us to really see What was the data when we looked to treatment effects according to the actual dose That the patient had for the majority of time in the study.
So basically that the dose dependency is most important in the So population is a territory, I guess. Yes. In this stage?
Yes. Because that's based on the actual dose they took.
And a final question. If you were to conduct the Phase free trial in house, What could how could a potential commercialization look like? Would you need a distribution partner or like a licensing agreement In the NDA stage, yes, what are the alternatives?
Okay. Bruno will do that.
Yes. Of course, if we were to run a Phase 3 study. We can't today say what would it be because we need to have the end of Phase 2 meeting with the FDA. But what we could foresee, that is that a Phase III study to repeat The findings we see in the Phase 2b study would be of the same size, so roughly 150 patients per study. Of course, we need to confirm that in the FDA discussion.
But if that is so, then definitely It would be something that Iglad could do on its own. Then coming to the commercialization. We don't have a Commercialization organization. So the most likely scenario would be that we would need to have an agreement with someone with Commercial muscle to really introduce the product to the market. But again, All the days today, we can't give you more than speculation at this time.
As we said, it's 1 week since we secured the product and got back the control of development and conversation. We have some homework to do to really define exactly answers to the questions you have, but we are very pleased To have now a Phase III ready product in the portfolio that we have full control of, and it has strengthened our position.
Yes. Just the confirmation of what you said, again, about 150 patients. Is your hope that you could have the one trial Preapproval or 2? Or has it changed since
That's a matter of discussion with regulators across the globe. And first of all, and foremost, the FDA. There is precedent in these types of indications that you can get bring Phase IIb, Phase IIa study as support for 1 trial, one pivotal trial. But this is an open question. We don't have the answer to that.
Otherwise, one does the 2 trial strategy. Then also one is to hedge for the safety population, which is about 100 treatment years that needs to be added to the study.
Could I just add here one aspect that I think is important when we talk about would it be possible for a small company like AirLab to run Phase III. And as I stated, yes, I believe so. And one important thing is not just the sample size. We're talking about An efficacy trial of about 150 patients. What is even more important that is that we're here talking about a treatment period of 3 months as we estimate.
And this should be compared to the Alzheimer's trials that we've seen over the last year being in the range of 2 to 3 years and in 1500, 2000 patient per study. So it is a very different situation that we are facing, and this is why we state we believe that it could actually be realistic to run Phase 3 also from a small company in this indication.
Thank you. That's all for me.
Thank you so much, Fredrik Thore. It's Time to move on. And next up is Sue Romanov from Edison. Please go ahead with your questions.
Hi, good morning. Thank you for taking my questions. It was good to hear the details on Mesopotam. You have a lot going on and you've made good progress on your Phase 2b trial for peripimat for balance and avoiding falls. And it was great to hear the timing, the confirmation of the timing for recruitment and the top line results In the first half.
In your opinion, what would you constitute a clinically meaningful result?
That's something we've discussed before, and it's an interesting question, Sue. The if one goes to the literature, about 25% reduction in the fall rate is perceived as a meaningful clinically meaningful effect. If we go back to our own calculations from the Phase IIa study, we see that we can actually exceed that or we Hope we can exceed that, but the data there supports a larger effect. But somewhere around 25% to But let's say between 20% 40% improvement would be really, really a huge leap forward in the treatment in the possible treatment of this Problem for Parkinson patients.
We should not forget that at present, there is no treatment available to reduce Even a fraction of the risk of falls. So any improvement here would be of clinical relevance?
Yes. That makes sense. I'm always interested to hear about your ISP research platform, and I'm looking forward to hearing more future milestones. But do we anticipate any new candidates entering Phase 1 for the clinical trial in the near term?
Yes. As we presented today, we will have 757 Phase 1 ready by the end of the year, which means that the next step would be clinical trials, first of all in health volunteers and later on in patients. Same with 942. During next year, we will have it ready for Phase 1 as well. And perhaps also even 11.17.
And that would in 2025, we would have a company here with 2 Late stage programs, 1 in Phase 3 perhaps and even 1 approaching Phase 3, and then a number of Phase 1 assets moving towards Phase 2. So we have a quite hefty work ahead of us, But that's also good for all our stakeholders.
Yes. It's good to hear about those. And that was kind of my next question on The MSRD, how do we have any is there any other updates you can give us on those discussions? I mean, that's obviously a huge Positive and kind of kudos to you guys on the ISP.
The only thing I can add here to what we've already presented, that is that we are in this period where they are evaluating our Compounds, of course, we are continuing developing activities with the compound to drive them forward. We see that this is something that we are hoping to come through. But of course, We are at such an early stage where still the molecules are evaluated by the other side. And we're awaiting to see their feedback where the discussions can continue. Any development in the discussions It's, of course, something that we will actively communicate.
But the good thing is that we are in these discussions now, and we'll see where they land.
Yes. And an important addition is that it's not only one way evaluation. We have a reciprocal evaluation and looking at How would a collaboration look from our perspective to be good enough for entering into such a collaboration? So there are lots of things going on, which we cannot, of course, discuss. But when we have some reached some milestone in these discussions, we will, of course, Provide that information.
We're obliged to.
Right. Okay. Thank you for the update.
Thank you, Sue. And last but not least, we have Gonzalo Artyak from ABG Sundal Collier. Please go ahead.
Hello, and thank you for taking my questions. I will start with 1 on the data you just presented on the 28th at the MDS Congress. If we focus there in the baseline characteristics of the treated population with meslopetam that you presented there, it seems that the group that received the highest dose of Ms. Dopetan also received a higher dose on average of levodopa, 32% higher versus placebo, to be more exact. Why do you have this difference in levodopa dosing across groups?
And what are the implications, if any, of this difference On the positive signal that you have seen in this group?
The way we see it is very little. This is not an important difference between the group. It's by chance, of course, that they end up with these differences perhaps differences in doses. But this is also individualized treatment with levodopa, individualized dosing for all of the patients, but stable during the trial. And it just happened to come out like that.
So that has nothing really we don't see that as influencing the results at this stage.
Okay. Thank you. And the second one also in the same data set And presented. It's regarding the primary endpoint of this study. The improvement of 1.75 hours, it seems to come from a POSCO analysis of the data Scale to 16 hours a week.
Could you give us a bit more color on this measure? And has it ever been used In that way, at least 16 hours adjustment as a primary endpoint in any Phase III previous Phase III study?
As we move along, we will likely not use the diaries as the tool for the primary endpoint, as pointed out before. We will Now since Eudis RS is the preferred endpoint for regulators, that's probably or most likely the way we will go. And also given the fantastic results we have in the Phase IIa study, the results on Ulysse RS in the Phase IIa study is on par or better with what has been published with other treatments before in registration files. So therefore, that's a quite likely way forward for us. The normalization to 16 hour wake hour Time is something that we were advised that the FDA does with the data.
When they get the data set, they do that calculation to control for variability in sleeping time or patient individual sleeping time, so that You compare apples with apples, so to speak, instead of apples with pears. So that's something that they do, and we wanted to do that to be sure that we don't miss anything out. And then the when you say post hoc, that has to do with the compliance of the in the patient population. We wanted to look at the patients that actually took their medicines more than 80% of the time during the trial, and that was done at that stage.
Okay, great. And one last question from my side. It's from the report today. You mentioned that the Pirapema trial is recruiting slightly slower than expected and that there are actions being taken right now to speed up the recruitment. Could you give us some color on these measures that you're implementing now?
The measures we've been implementing during the summer and the spring actually is adding one country, the Netherlands, Opening up 2 sites in the Netherlands, quite large sites. And there, we have the world's experts in falls in Parkinson as well. So and then we are taking measures at every site. And I can't go into details because they would be Too complicated to explain, but details on how we incentivize the patients and the doctors to actually get into the trial.
Great. All clear from my side. Thank you very much.
Thank you so much, Gonzalo. And it's The hours have gone fast. Thank you so much for presenting. Thank you for viewing, and welcome back the next time.
Thank you.