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1. Bull, Bear & Beyond: IRLAB Therapeutics – executive interview
4 Plays4 days ago
IRLAB Therapeutics (OMX: IRLAB-A) is a Sweden-based biopharma company focused on the development of novel treatments for neurodegenerative diseases, with a particular focus on Parkinson’s disease (PD). The company has a highly active pipeline, with assets spanning all stages of clinical development, from preclinical programmes through to its lead asset, mesdopetam, which is Phase III-ready.
Mesdopetam is being developed for levodopa-induced dyskinesias and, following a successful end-of-Phase II meeting with the US FDA, IRLAB is gearing up for a registrational Phase III programme. This could commence by end-2024/early 2025, contingent on successful partnership discussions. IRLAB’s second asset, pirepemat, is designed to improve balance and reduce falls in PD patients and is currently involved in a Phase IIb trial. Patient enrolment should be complete within Q324, and we anticipate top-line results from H125. IRL757 is being developed as a potential treatment for apathy in PD and Alzheimer’s disease patients, and it is the company’s latest candidate to enter the clinic. First-in-human studies commenced in May 2024 and we expect initial data in Q125. We highlight that this programme is somewhat de-risked, with the Michael J Fox Foundation financing the current Phase I study and the McQuade Center for Strategic Research and Development set to fund subsequent R&D efforts through to proof-of-concept. Preclinical assets IRL942 (for cognitive impairment) and IRL1117 (for PD) could both be Phase I-ready from end-2024/early 2025.
In this video we speak to Kristina Torfgård, IRLAB’s new CEO as of August 2024, and learn more about her wealth of experience in drug development, what drew her to IRLAB and her strategic priorities as the company approaches key upcoming milestones.
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Transcript
Introduction of Christina, CEO of UrLab
00:00:07
Speaker
Hello, I'm Sue Romanoff and today we're speaking with the recently appointed CEO of UrLab, which is a Swedish biotech with late stage and preclinical assets in Parkinson's disease.
00:00:19
Speaker
Welcome, Christina. Thank you so much. So you have an amazing pharma background. it'd be really great if you could share a little bit of that with us and then also let us know what drew you to UrLab.
00:00:34
Speaker
So yes, of course. So I've been working with drug development that more than 30 years and I've been both working for the big pharma companies and for smaller bio of pharma companies as well.
00:00:46
Speaker
um And I have been part of of drug development, working pre-clinically, but also in clinical phases and being responsible for marketed product as well.
Christina's Experience in Neuroscience
00:00:57
Speaker
So I can have quite a broad background and have plenty of experience from regulatory authorities, interactions, and um also ah business development and um and licensing deals sitting on the both sides of table, so to say.
00:01:12
Speaker
so ah But I've spent a number of years working in the neuroscience field, primarily working with Parkinson's disease and Alzheimer's disease. So um during this this year, I've had got a very good understanding of the huge unmet medical need in this area.
00:01:30
Speaker
However, it's also self very complex and challenging to develop um great ah drugs in this field.
UrLab's Platform and Team
00:01:38
Speaker
And here comes iLab in. This is what I've seen, ah that it's an amazing company, really.
00:01:44
Speaker
ah First of all, with the platform that the company has, ah which has generated five candidates in in this world-leading portfolio, I would say, in Parkinson's disease.
00:01:56
Speaker
And then I think... the team behind the company is really ah fantastic. It's a talented and a dedicated team and that has been working together for a very long time and they were really, really on board already at the time with Arvid Karlsson in his lab. Arvid Karlsson who got the Nobel Prize many years ago.
00:02:19
Speaker
So now I'm really looking forward heading up Iolab and lead the company through this exciting journey where we are going now to to from here now move in and and go into and market these products.
UrLab's Strategic Market Goals
00:02:34
Speaker
And we will do that through um ah partnering activities and then eventually we will get this on the market. So that's going to be great both for for patients with people with suffering from Parkinson's disease, but it will also increase the value for the company and the shareholders.
00:02:52
Speaker
Yeah, no, I totally agree. it's ah It's a very exciting space and it's very complex. I'm i'm really excited on the work that you're doing. ah So you also have a um so you have a strong discovery platform and it's really endorsed by the progression of your three leading assets that are in clinic.
00:03:14
Speaker
Could you could you um highlight what the key differentiators are from your peers? Yeah, I would say that that this um unique platform is really the differentiator here.
00:03:28
Speaker
Because with the knowledge, all the data generated for more than 1000 candidates and and molecules that put in this database,
00:03:39
Speaker
And with machine learning and AA-based analysis, the candidates are selected. um Our own calculations, when we have looked into peers there, how they have been doing, we can see that we have a probability with more than three times better success rate, bringing our candidates from candidate drag into later stage of clinical programs.
Key Drug Candidates in Development
00:04:05
Speaker
and And maybe you can kind of highlight your three assets as well. ah you have Mesopotam, Pirpamat, and then IRL 757.
00:04:14
Speaker
Yes, if we start with mestopetan, which is a candidate that is developed for levodopa dyskinesia. This is something that many ah ah individuals with Parkinson's disease suffer from when they have been treated for for some time with levodopa.
00:04:33
Speaker
um And this candidate is phase three ready now. um So we are currently preparing to go in in in in clinical phase three. d ah We are are having regulatory interactions and then we are ah working to find a partner to to do the phase three program here.
00:04:54
Speaker
um So then we have the second candidate, which is Peripimat. um And that candidate is developed for, ah for him I would say, falls and for instability.
00:05:08
Speaker
This is something that... um probably 45% of all individuals with Parkinson's disease, they they suffer from this. So it's a lot of people um and the it's a very big market, of course.
00:05:22
Speaker
So it's important for us to take this further. And and this is really um a new indication. Nothing is ah available or in in development for for this specific indication. So that's very important.
00:05:38
Speaker
um And here we have an ongoing study in phase two right now and that we're looking forward to get results from. And then the third clinical candidate, it's PIV7.
00:05:51
Speaker
And that's a candidate to be developed for apathy. And that could be both in Parkinson's and in Alzheimer's disease. ah This candidate has just entered phase one.
00:06:04
Speaker
ah in a phase one um and first in human study. And we are really proud because this first study has been financed by Michael J. Fox Foundation.
Collaborations and Funding
00:06:17
Speaker
And then in addition to this, we have recently a collaboration that we have started with MSRD Otsuka, a Japanese company. And they are going to ah finance and fund all the development up to ah proof of principle.
00:06:34
Speaker
um So it's quite amazing that already for this candidate that we have funding all the way through up to proof of concept. Yeah, and and besides your clinical stage assets, you have a very active preclinical ah um platform, right? I mean, in addition to the the ISP discovery platform.
00:06:55
Speaker
could could you ah Could you speak to these? Yes, what we have here is really, and I should have said that already already from the beginning, all these candidates are actually unique in the way that they are first in class.
00:07:09
Speaker
They are new um sort of new mechanism. um So it's really good um so and unique. And the first preclinical candidate here that we are talking about is 942.
00:07:24
Speaker
And the target indication here is um targeting, no ah I would say, cognitive flu function in all different types of neurological disorders, ah which is quite broad.
00:07:39
Speaker
ah So, and ah we know that about 12% of all ah individuals above 65% experience this type of cognitive dysfunction.
00:07:50
Speaker
So it's going to be a very big market here too. um And, um, Then we have 1117, the last but not least one, because this we think has a huge opportunity here to be a new generation of Parkinson treatments.
00:08:07
Speaker
And like Livudupa, which is the golden stutter right now, this has the same kind of mechanism. D1, D2 receptor agonist, but without any name side effects.
00:08:21
Speaker
um And side effects is very, very common ah and a very common complication with levodopa. So we believe that as you in front of us, that we can develop this one to be really the the the basic treatment for most of the people, individuals diagnosed with Parkinson in
Future Milestones and Opportunities
00:08:42
Speaker
the future.
00:08:42
Speaker
Yeah, that's that's a lot. So maybe maybe um for investors, it will be helpful to know what what the next milestones and catalyst will be for the next 12 to 18 months.
00:08:55
Speaker
Yes, stu it's it's very exciting ah because we do have a number of upcoming key milestones and value adding um activities now both for for for the company and for its shareholders.
00:09:09
Speaker
ah So if we start with Mestopiton, we are currently having ongoing interactions with the regulatory authorities in Europe. Earlier this year, we had a very good and successful meeting with the FDA about the phase three program. And we do the similar way here with Europe. So we can have a studies that will be um that will really be, I would say, successful um and meet all the requirements in both regions, in the US and in Europe.
00:09:43
Speaker
And then for peripimat, we have ah we in September now, we are doing ah going to complete um the recruitment. um And when we have all the patients in the trial, then we can expect to get a results from this phase 2b study.
00:10:01
Speaker
sometimes first half of 2025, which is very exciting. So hopefully with then we will have two candidates ready to start their phase three. And then we have 757.
00:10:14
Speaker
and We have the ongoing first in human, the clinical study. um And we are planning to to have the study completed by end of the year and then to start a proof of principle study yeah next year.
00:10:29
Speaker
um And then for the two preclinical assets, we are pairing both of them to go into first in human study, first in man clinical studies. um the who ah or The plan is to go there and first half of 2025.
00:10:45
Speaker
So you can see it's it's a lot of things happening in iLab right now and it's really exciting time. Yeah, it's it's a really exciting time. So I appreciate you taking the time to speak with me.
00:10:57
Speaker
Thank you all for joining us here today. If you'd like to learn more about UrLab, please refer to edisongroup.com. Thank you.