Welcome everyone. It's my pleasure to have Carl-Johan Dalsgaard, the CEO of Vicore Pharma with us today. The key question we often get is on the IPF data that has been quite unique.
Mm-hmm
...so far. What would you highlight about the last readout in November last year?
I think what is clear is that we're stabilizing the disease now over 36 weeks. The data that we had in November actually is stronger than the data that we had in February. We have more patients, stronger data, and a clear stabilization. That is really unprecedented. That means that if we diagnose early and medicate, we may even stop this deadly disease.
Great. Now looking forward to the expected final readout-
Mm-hmm
...of that study. when, can we expect it, and how many patients can we expect at, 24 weeks and 36 weeks? If you can give a bit of a.
I can say that we have 25 plus patients now for 24 weeks, and we expect to have, of course, them moving ahead. We would have a substantial data set already by summer with patients going into a 36 weeks end of trial. We still have patients now recruited, and we expect the final data by the end of the year. But by summer, we will know pretty well what it looks like. Again, it's a substantial data set that is emerging now.
We can expect around double as many patients-
Yeah. Oh, yeah
...week 24, 36, and even-
Even more, yes.
Okay. Well, great. Also one question that came up a lot was about the dropouts that you had previously. Can you say now that these dropouts have decreased since November now going forward?
Yeah. I mean, what we can see is that the dropout frequency is going down. That is primarily because of COVID, because COVID was a real issue for us because patients were either afraid of COVID. With this deadly disease, you don't wanna go to hospitals for visit every second week. That is I think understandable. That is not a problem for us right now. We see less dropouts. There always a frequency of about 20% dropouts in these types of studies.
Okay. Thank you. The geographic distribution, could you elaborate a bit how the patients are distributed?
Mm-hmm.
Also one question we sometimes got, is there a difference in the Indian sites? If you could walk us through a bit how Indian patients are assessed, if there is a difference or not.
Yeah. There is no difference actually. We have about 75%, 73% of patients now from India, and then we have the rest then from U.K., Ukraine, Russia. Obviously, we're not having any patients in Russia, Ukraine now. That's the balance we have. The patients are all clinically diagnosed according to the guidelines, whether they're in India, U.K. or Russia or Ukraine. We have a high-resolution computed tomography that is then sent for a central reader in U.K., Professor Devaraj, at Royal Brompton in London. He does all the readings, and he's a world expert in doing these readings for diagnosis. Of course, you have to be very thorough in that analysis.
We also seen a lot of screen failures because we were not 100% sure that we had IPF disease. When we have IPF disease, when we know that we have the traction bronchiectasis that they can see, we know that these patients will lose about 250 mLs per year. That's what we've seen in all the published studies on placebo groups, plus minus of course, but around that level. That's, that's important to be sure that the diagnosis is right. Number two is that we have a standardized way of measuring FVC. That's a gold standard, the ERT system. They over-read, and they work with us so that they control that the measurements make sense and that they've done the utmost for doing this.
They actually also train the sites to do these measurements. In addition, we have been there ourselves in the two highest recruiting sites and visited even a few more to do with proper audits and making sure that when we see them do these analysis, that they know how to do it and that they're doing it properly and that everything is under control. I would say that, the Indian population in this trial is as much IPF as any other population in any other trial.
Thank you for that elaborate answer. Yeah, you're not alone in this space of IPF. You might be.
Mm-hmm
...valuation-wise a bit alone. Pliant Therapeutics has recently released some IPF data, first in summer last year and again now in February.
Yeah.
How would you assess that data?
Well, I mean, Pliant showed some encouraging maybe 12-week data, but it's a small study and a short time period, and it's very difficult to interpret data with small and short time periods. Will of course be interesting to see. They will come with 24-week data on the high dose group and see if it holds up. The difference there is that their slope is going downward and our trajectory, our stabilization is actually trending upwards over time. I think that's a big difference. Again, I mean, they don't have long-term data either.
One last question maybe, and that is on the next stage then, and then maybe a bit timelines. What can we expect for the Phase 2b trial in terms of size and implications? Is it potentially pivotal? Is that a stretch? How could that be pivotal? When can we expect it to start?
Well, as you can imagine, I mean IPF is our top priority with C21 now, and it's really our focus. We've been working both with an advisory group of key opinion leaders from different countries in the world: U.S., Japan, Europe, and making sure that we make a very solid Phase 2b trial. We also interacted with the FDA in so-called pre-IND meetings to make sure that we know what they want to see in the next step. We will do a Phase 2b trial with two doses. It will be powered enough to really pick up the differences that we see. It will be a double-blind and placebo-controlled trial, and we will also take all comers.
Not only patients who are not on any other standard of care, so to speak. It will be all comers. That will of course have a big impact on recruitment pace, and also the possibility to use the data in an early access. Because I believe that if this data repeat itself in a solid Phase 2b trial, we should definitely have the courage to go and see if we can get an early access with the drug. Meaning that we also then need to do more trials. At least in the situation where there's nothing but what we have today as a standard of care, I think there's a huge medical need and that should be possible.
The trial since we believe we expect to start early next year, it's a lot of planning, we're, I think it's important that we do a solid trial as the next trial, for the reasons that we just elaborated on.
Thank you very much. Thank you for coming out, Carl. Thank you for watching.
Thank you.