One of the companies presenting here at Pareto Securities annual healthcare conference is IRLAB Therapeutics, and I say a very warm welcome to Richard Godfrey, CEO of the company.
Very nice to be here. Thank you for the invitation and the opportunity to meet with you. Thank you.
Yes. You've only been with the company for a couple of weeks.
Well, actually, I started on the first of July, which was a little bit unusual because everyone then promptly went on holiday.
Yeah.
I guess I've had a few weeks during August when I've been able to get up to speed and work with the team.
How do you like it so far?
Oh, it's amazing. I mean, I did a lot of due diligence in the recruitment process.
Mm-hmm.
A lot of research, spoke to a lot of people in trying to understand the landscape, and then touched down in Gothenburg, which is quite an amazing city. Really happy there.
Yeah.
The weather's been tremendous during the summer, and I feel I've really settled in and got up to speed quickly. Oops.
The IRLAB is a clinical-stage Swedish company.
It is.
that works and develops a treatment for Parkinson's disease.
That's right, yes. That's exactly right. Clinical stage, research and development company. Quite focused strategy now on developing medicines to treat the really troublesome symptoms and complications of patients living with Parkinson's disease.
One of your most advanced candidates is mesdopetam.
It is, yes. Maybe just backtrack a little bit. In doing my research before I joined IRLAB, I was curious about what's the standard of care, how has the treatment evolved since I studied. You know, I'm a pharmacist, I studied many diseases and therapeutics at university a long time ago.
Mm-hmm.
You know what? There's been no real progress. In 30, 40, 50 years, there's been no real progress in the standard of care to treat Parkinson's, and the patient journey continues. This is not just a short-term patient disease. Patients live with Parkinson's disease for 20+ years, and it's a neurodegenerative disease. You know, it gets worse and worse and worse over time. The base treatment is a drug called levodopa, which really works very, very well. What's really fascinating and gives great confidence is that the mechanism, what causes Parkinson's disease is neurodegeneration in the brain and results in a reduction in the amount of dopamine, a neurotransmitter in the brain.
That was discovered by a professor in Gothenburg, Arvid Carlsson, and he got a Nobel Prize for that.
Mm-hmm.
He then discovered levodopa as a drug, which was launched in 1969 and has been and continues the mainstay of treatment. You know what? It's a good drug, but it's not perfect. It's got lots of complications, and the disease continues to progress. The most frequent and the most obvious complication of Parkinson's disease and levodopa is this so-called dyskinesia. The patient's taken the drug, it works quite well, and their motor function returns to normal for many hours of the day, 4, 5, 6, 7 hours of the day, but then, you know, the disease continues to progress, and they get this breakthrough dyskinesia, and they have this shake which we all recognize in people.
Yeah.
It's because the brain that's driving the disease is not functioning properly. Our lead program is called mesdopetam, and it's specifically designed and engineered so that addresses this dyskinesia.
Mm-hmm.
You take it in addition to levodopa, and it stops this dyskinesia and gives you more of the so-called Good ON time when the motor function and the control of our bodies or the patient's body is restored to normal. It really is, you know, the potential of a breakthrough and indeed, you know, this is a blockbuster drug.
Mm-hmm.
Our phase 2a study, our proof of concept data was really quite compelling, really, you know, offering more than 2.5 hours per day of extra Good ON time.
Mm-hmm.
Extremely well-tolerated. You know, the safety profile is excellent. You know, but we were able to license this to Ipsen. It's a, you know, global biopharmaceutical company, saw the potential and gave real high-quality validation into the science, the clinical data, and the commercial opportunity that this drug represents. They secured the global rights to continue the development and commercialize the drug.
Mm-hmm.
We continue with the Phase 2b study now.
Yeah.
That's 150 patients.
Now you tried it, and you said that it works.
It works.
Now it's next step.
Next step is a bigger.
Get patients
Proof of concept study.
Yeah.
Now it's in 154 patients, and we'll be reporting out data by the end of the year.
Mm-hmm.
Now, that's really quite exciting. After eight years of research, we've now gone through the early clinical development stages, confirmed safety, and now we're doing a real proof of concept study, and as I say, we'll have data at the end of the year. As I assuming that that's favorable, then our partner, Ipsen, will then take over the baton, and they'll take it into Phase III and commercialize it.
All right. The study is only a couple of months.
Well, the study's been open for more than a year.
Mm-hmm.
We're in the very last stages of it now. The last few patients are being enrolled, and then we'll be able to run the study for 3 months and then capture all the data and report headline data.
We could expect some readouts later this year?
Yeah. Hopefully by the end of the year.
Mm-hmm.
That's what we're targeting.
Do you have any other? Because you have a product portfolio.
We do.
Do you have any other exciting?
Yeah
Products you would like to share with us?
Sure. Well, what was fascinating when I started my research is understanding the so-called patient journey.
Mm-hmm.
This is a neurodegenerative disease. Patients suffer with this disease for 20+ years. At the beginning, we have this dyskinesia, which we think we can address with mesdopetam. Possibly the most troublesome of consequences of Parkinson's disease is the reduction in our ability to balance.
Mm-hmm
Increased frequency of falls, and that really limits the patients. They lose confidence, their caregivers, their families lose confidence, and it really restricts their quality of life. Our second program called pirepemat is in a similar size study, phase 2b proof of concept study, 160 patients where we're looking to see if we can reduce the numbers of falls that patients have. That study is open, it's recruiting, and we anticipate being able to have data by the end of next year. In our early phase 2a study, we saw quite compelling results. 50% reduction in falls. 70% increase in caregiver confidence, reduction in apathy.
An awful lot of very, very encouraging early clinical data, and we hope we can reinforce that with this phase 2b study that will report out at the end of next year.
All of those projects are complements to each other.
That's right. They are indeed, absolutely. There's two other programs that we're looking to take into the clinic next year. One for cognitive function, reasoning, decision-making, et cetera, and another one in apathy. We have two additional preclinical programs that we've taken to the clinic next year. We've also have a research project that hopefully will be able to be a one-a-day solution for patients without these troublesome complications.
Mm.
A very rich pipeline, going from early research stage through to late development stage. True validation with our partnership with Ipsen and the potential. Each one of these has got blockbuster potential and collectively a very attractive biopharmaceutical business potential.
You talked about commercialization before, but are you looking for FDA approval in the US or here in Europe?
Sure. Well, pirepemat is being developed in the U.S. and in Europe.
Yeah
with open IND in America and across Europe, and I'm sure that Ipsen would develop that in both America and Europe. At the moment with pirepemat we're just developing that in Europe, but of course, you know, the global market is a really attractive place.
Mm.
Most definitely looking for a clearance in America and Europe and further afield and of course, you know, I think we need to be grounded. We can't really think that we can develop and commercialize all of these assets on our own. We're going to need partners.
Mm-hmm.
Ipsen's a great partner for one of our drugs, and we can go as far as we can to release the value and the potential in the other assets as we go through the journey. The one-year outlook is really exciting and it's like I can hardly contain myself. As with good data, good fortune, you know, mesdopetam will have reported positive phase 2b data, and Ipsen will be progressing that into phase 3, maybe even by this time next year, announce the phase 3 study.
Mm.
Our second program, pirepemat, will be well and truly a long way through the phase 2b study. While we won't have sight of data, we'll be getting quite excited about when that data will be, hopefully the end of next year. These two other programs will be in the clinic.
Mm.
Unencumbered assets that we're developing ourselves, we have three of them all addressing these troublesome complications of Parkinson's disease, and I think we'll be quite mature in our preclinical development of the one-a-day Parkinson's treatment pill.
Mm-hmm.
A lot is gonna happen in developments and, say, hopefully we'll have very strong news flow on the back of our rich pipeline.
Mm
... be able to really sort of develop our business to be a very successful for patients, for shareholders and for society.
Yeah. I'm looking forward to see you here next year.
Yeah, me too.
Good luck with everything. Thank you very much, Richard.
Thank you. Thank you very much indeed.