Good morning, and welcome to the ABGSC Investor Days. My name is Alexander Krämer. I am a Biopharma Analyst here at ABG. Today, I have the pleasure to host Kristina Torfgård, the CEO of IRLAB Therapeutics. Welcome, Kristina, and the stage is yours.
Thank you very much. Very nice to be here, and I am very pleased to present IRLAB. First of all, I would like to excuse my bad voice. I had a cold last week, and apparently it has not recovered, but I hope you can follow me anyway. This is not working. Oh, that one. Thank you. Thank you so much. Let us try. This is our disclaimer. IRLAB, we are a Swedish biopharma company developing new innovative, much better medicines for treating Parkinson's disease. I am sure that many of you might know someone that has Parkinson's, and I have seen that this is a lifelong disease. Around 11 million individuals are living with that today, and this is a figure that is going to double during the coming 15 to 20 years. Today, unfortunately, there is still a lack of good medicines to treat Parkinson's individuals with.
We at IRLAB, our aim is really to make a difference with our new medicines. We do that because we have vast experience in the field. Our company is founded by scientists that have been working together with Arvid Carlsson, Professor Arvid Carlsson, who received the Nobel Prize for dopamine and the research there in 2000. So we have a great experience in the field. In addition to this, we have a unique platform that I will talk about. This platform makes it possible for us to develop candidates that are very good, have good efficacy and good safety. But also through this platform, it makes us have better success rates so we can take them through the development in a faster space, but also to less cost.
All three components are doing that we are in a good place where we have good position to develop these new innovative treatments to make a difference for individuals living with Parkinson's disease. Our strategy and business model. Our aim is to cover all the different stages of Parkinson's disease, all different symptoms, but also other CNS-related diseases. We do that through our unique platform. As you can see here, we get true innovation in the candidates that we are developing. We have higher success rate and also a very strong patent for these candidates that we take through this platform, the ISP, which is called Integrative Screening Process.
We develop these CDs, that we call them, up till a proof of concept, which is normally in phase II, when we have documented that we have a good efficacy in the target population where its aim to treat the patients in the future. Then we look for partners, different types of setup we can see there. Through this partnering, we get upfront payment, milestone, and royalties. Parkinson's disease is a progressive, lifelong disease, and you can see that it starts already around 20 years before the individual gets the diagnosis. The diagnosis is set on a typical slow movement, stiffness, and tremor, the shaking. You can see that eventually, a number of different symptoms and complications are developing through their life. We have first-in-class candidates that we are developing, and the first lead candidate is mesdopetam.
We are developing that first for dyskinesia, levodopa-induced dyskinesia, but it can also be developed for treating hallucination, confusion, and psychosis in the long run. The second candidate, pirepemat, will take care of balance and falls, but it can also be developed further into speech impairments and swallowing difficulties. The third candidate, IRL757, is currently developed for apathy. IRL942 is developed for cognitive impairment. Then IRL1117, this is sort of a new generation of Parkinson's treatment that we are looking forward to see. Here we take care of the cardinal and the typical core symptoms, which is slow movement, stiffness, and tremor shaking. You can see we are aiming to cover many different symptoms and complications through the disease journey for the Parkinson's individuals. Oops, too fast. I talked about that we have a unique platform.
This is a discovery platform, an Integrative Screening Process. We have, since 2000, collected information data from in-house generated molecules, compounds, and we have generated that and have a database. Together with reference compounds, so to say, which can be drug on the market or that have been through clinical testing. This we have gathered and performed a lot of different experiments and trials. With machine learning, AI, this is, I would to point out that we were very early using AI here, already starting in 2000. We are using that, and through this work, we can really select and find those candidate which has the best properties for different types of indications. Here is a comparison. You can see that the probability for us to start in preclinical and take them through up to phase III is around 20%.
If you compare that with industry standard, which is more of the traditional way of target-based research, this is current around 7%. It's a better probability, it's faster, and also less cost involved in this. We are of course very proud of this platform. We think that we can use that for many other candidates to be selected in the future. However, here you can see our portfolio, and I would dare to say that this is one of the world's best portfolio for candidates in developing treatment for Parkinson's disease. This is thanks to the platform. The lead candidate, mesdopetam, is in phase III. Sorry, it's in phase III-ready phase. We have everything ready to start there. We are hoping to do that next year. I'll talk more about that candidate in depth.
But here we also have the opportunity to broaden the indication and broaden the market into psychosis. For pirepemat, we are currently in phase II. We have an ongoing trial that is going to read out early next year, so it is very exciting. This is the indication for impaired balance and falls. I will talk more about that also. And you can see here we also have the opportunity to broaden the indication at the market. Then we have IRL757, which is developed for apathy, and the goal is to develop that both for Parkinson and Alzheimer's disease. Here we have a collaboration, first of all with The Michael J. Fox Foundation, but also with MSRD Otsuka. We have two preclinical assets. It is IRL942 for cognitive impairment. The aim is to bring that candidate into clinical phase next year. And then IRL1117 also to bring that into clinical next year.
So I will focus a little bit more on each of the candidates now. So mesdopetam, it is a unique first-in-class candidate. It is inhibiting the dopamine D3 receptors. And that takes care of the typical levodopa dyskinesia. And for those who have not heard about that, levodopa-induced dyskinesia is when individual have been taking levodopa, which is the golden standard treatment, for a number of years. For some reason, around 25%-40% of all these patients, they are starting to experience involuntary movements. They are like this, and they cannot really control that. And of course, that is very troublesome. So the purpose is to take care of that with this candidate. We have a quite addressable, huge population here, between 1.4 and 2.2 million. So it is huge market. We have very compelling phase II-B data.
And as I said, we can broaden the indication moving in with a phase II study in psychosis. And the patent situation is great. We have recently extended with the possibility now to exclusivity in the early 2040, which is unique, I would say, for these type of candidates. Oops. So, what does it mean that we are phase III ready? So just to have some highlights on the phase II study that we got data some time ago. The phase II study was a dose-finding study. So the aim was really to select the right dose for the phase III. And we saw that we have a clear dose response, and we are going forward with 7.5 mg twice daily now. We saw a significant antidyskinesic effect in the study, which has been discussed with the regular authority.
And this is going to be the tool and the measurement that we are going to use for the primary endpoint in the phase III studies. In addition to the antidyskinesic effect, we also saw antiparkinson effect, which is a bonus, I would say. And this really differentiate us versus other available treatments on the market today. So during this year, we have had regulatory interactions. We have started off with the FDA interaction early this year and continue with meetings with European regulatory authorities. It was Germany and Portugal. And we have aligned our thoughts around the phase III program here. The measurement scale will be the Unified Dyskinesia Rating Scale, which is accepted and commonly used for this indication. We have a consensus on the program, where we are going with 7 mg twice daily.
We are targeting the same patient population as in the previous studies, which is very good, especially as we are aiming to generate data similar to the phase II-B data. In general, it is going to be around 250 to 270 patients, and they are going to be divided in two different phase III studies. Around 125 to 130 patients in each study. They are going to be treated with either mesdopetam or placebo. They are going to be treated for three months. Then all the candidates that are engaged, the subjects, they will be asked, and they can continue, if they would like, in an open-label study. Everyone then will get mesdopetam for a year, which will be generating data for us on the safety parameters that is needed for regulatory approval.
What we have done also to get phase III-ready is that we have done a market research, payer research. We have gone out to health providers and asked where they see a lack and where is an unmet medical need. They definitely see that mesdopetam has a place in the treatment algorithm there. With this information, we have now been able to design a phase III program that meets up to the requirements, both from a regulatory perspective but also from a market research and health economic perspective also. Pirepemat, our second candidate. This is also a first-in-class candidate, where we are aiming to improve balance and falls. We have compelling data from a phase II study and an ongoing phase II-B study. Also here we have similarly a patent exclusivity, which takes us into early 2040.
Today we know that falls and fear of falling, impaired balance, that is a huge problem and actually the biggest concern for many of the individuals living with Parkinson's. That is very troublesome for them. You can see around 45% of those with Parkinson's, they fall, which is a lot. Considering how expensive it is to take care of all these injuries, this can make a huge difference, not only for the patient but also for the society and for the healthcare. In total, it is around 2.5 million, the market that we can see that there is a population that we are targeting, and this is U.S., Europe, China, and Japan. We are pioneering in this field, doing the first study in patient with recurrent fall. This is an ongoing study in Europe. We have included and randomized all patients in the study.
The last one was included in September. End of first quarter next year is the time when we expect to be able to get the data. It is very exciting. IRL757, it is another first-in-class. It is fantastic to stand here and say first-in-class for every candidate, isn't it? This has an effect on the neuronal activity in the frontal-subcortical neurocircuits. This helps the area where apathy is. Here we can see that we can treat apathy in many different neurological disorders like Parkinson's and Alzheimer's disease. It can be both asymptomatic but also disease-modifying treatment, which would be fantastic. We have an ongoing study in collaboration with The Michael J. Fox Foundation for Parkinson's Research. We think that this is a very good validation of our research when they sponsor this study. We have also an ongoing phase I study with MSRD Otsuka.
I will talk a little bit more about that. Apathy is very common in both Alzheimer's disease and Parkinson's disease. We see addressable population is 2 million to 7 million people. It is a lot. There is no treatment at all for this complication. We have an agreement, a collaboration with MSRD Otsuka, that they pay for the development for this candidate all the way up till proof of concept. Then they will have the first option to look into data and license if they want. Otherwise, we can license it out to other potential pharma companies. The patent remain by us. It is a very beneficial collaboration for us. Then we have two preclinical assets. I just mentioned them. IRL942, which is going to be for improvement of cognition, where it is a huge unmet medical need, 5.8 million people around the world.
We are aiming to have this once daily. IRL1117, where we see that this could really revolutionize the Parkinson area, or treatment with a new treatment, a next generation Parkinson treatment, where this is aimed to be once daily because we have seen data that this would be enough with a once daily treatment. This should be compared with levodopa, where we have today, people take it 4 up to 10 times a day, which is a lot. In addition, we do not see that we will have any complications such as dyskinesia or motor fluctuations here. We have really big hope for this one. This is now five candidates that we are developing, and we have in our portfolio. It is quite impressive, I think, having all these candidates that all of them, each can be a blockbuster.
Here for the first one, mesdopetam, through our market research and payer research, this has been confirmed that this huge unmet medical need, and this is really correct figures. It has the potential to be a blockbuster. What is happening here in the next coming month? For mesdopetam, we are working on the business development and preparing for a partnering still, and we have big hope here. Then to start the phase III study as soon as possible with a partner. For pirepemat, it is very exciting with the upcoming data end of first quarter next year. There we of course, are also planning to go out and partner. We already have a very big interest here from big pharma.
For IRL757, we are completing the ongoing phase I studies that we have, and during next year we are preparing to initiate what we call proof of concept studies or signal studies in patients. Then for IRL942 and IRL1117, we are preparing to enter clinical phase. Very exciting time for us the coming 12 to 18 months. I will stop there and hand over.
Great. Thank you very much, Kristina Torfgård, for this very interesting presentation. I have a couple of questions.
For you and maybe to start with the first one with pirepemat. We expect data at the end of Q1, so we can basically say March. You also mentioned today that there is a lot of interest around this product. Could you maybe talk a little bit about in which timeframe do you expect to have such a deal with pirepemat with a pharma partner? Is it within one month or two months or three months? Also considering your financial runway.
Yeah. It is very hard to say because it is a teamwork to find a partner and it can even be not only one company, it can be different regions. But if we look, I just read how it is in the licensing and partnering area today. In 2024, it has only been around 400 deals, while in 2023 it was 700 deals. It is less of deals for some reason. So it is challenging, and that is what we are seeing with mesdopetam. I think we have a very big interest for pirepemat, but it is really hard to say. Usually it can take a year or even more.
Mm-hmm. All right.
We're just working very hard, I can tell you.
It could be that maybe you will have some sort of bridge financing, also considering your loan, which you have at the moment.
Everything depends on what's happening with mesdopetam.
Of course.
how soon we get there in. Then we can see different types of financing options, yeah.
Absolutely.
We are always looking into that.
Okay, great.
Yeah.
Then my next question is a little bit on the future of Parkinson's and Alzheimer's treatment. You are well aware, of course, also the local peers here, BioArctic, for example. There is novel modalities, novel concepts in Alzheimer and Parkinson research, also by several big pharma companies. I would like to discuss or hear your opinion a little bit how your very nice and very extensive pipeline could fit into this future treatment landscape that comes up with drugs like LEQEMBI, for example.
I have been working with Alzheimer's in the past. I have a good understanding there. I think it is great that Alzheimer, that there has really been a breakthrough there. There is a huge interest from big pharma.
That is a must because the studies there needs to be very large and long, 18 months treatment and studies like almost 2,000 patients. That is why you are targeting the big pharma there. For Parkinson's, I think we are a little bit just behind there, and I think that it is going to move also here. Big interest, we can see that for the whole CNS area, I would say from different pharma companies. Here we have the advantage that as you saw our studies for phase III, it is around say 250, 300 patients. It is much less, three months treatment. It is much easier to finance those programs. I think that is a benefit for us really.
Mm-hmm. Okay, very interesting. Maybe a final, very short question on your mesdopetam planned phase III program. Could you give some guidance on what the cost for such a program is? In which range are we talking about what the mesdopetam phase III program would cost?
It is really hard to say the cost. I do not think that we have expressed that publicly. It is very little compared to the huge Alzheimer's studies I can say. But we prefer to have a partner to run phase III. Not only for the cost of the program, it is more for preparing also for the market for the commercialization. I think the candidate benefits a lot from having a larger partner on board to take care of that. Because then we will get on the market faster, which is very important.
Mm-hmm. Great, Kristina. Thank you very much for coming today. With that, I will close the session. Thank you.
Thank you.