And I think it’s — it’s a scientific progress. Of course, at the end, we want to and we need to demonstrate clinical benefit as well, which is the goal of the Phase II study. And we’re not too far from that, I think, April 25. Not too far from now. And given the, as I said before, the huge unmet medical need in all forms of progressive MS, namely the non-inflammatory advanced secondary progressive MS population, we think that vidofludimus calcium is really the opportunity to change the way we treat these diseases.
Matthew Kaplan: Okay. That’s helpful. And then you mentioned business development plans or partnering plans. What are your plans for the MS indications for vidofludimus in terms of partnering?
Daniel Vitt: Yes. I think given that some people we are talking to, I mean they’re also on the line here, I tend to be careful on projections and the status on BD discussions. But I think we do what we always do. We establish collaborations. We establish trust relationships to potential partners. And progressing towards the readout, I think, clearly paves the way also for partnerships. If the Phase II PMS data is positive, this is certainly something which has a relevance for the whole treatment landscape of multiple sclerosis, even beyond PMS, because that may also be of benefit for and support scientifically the ENSURE RMS Phase III studies which are ongoing as well. So I think this is something we have really some activity on we, but we are not in a situation that we say we need to do something now. I think we have the funding available to read out the Phase II study in a good way and then to look what is the best way forward here.
Matthew Kaplan: Okay. Great. Thanks for the added detail.
Daniel Vitt: Yeah. Thank you, Matt.
Jessica Breu: Thank you, Matt. [Operator Instructions] And the next one here is Jun-Goo Kwak from Piper Sandler. Jun-Goo, please unmute yourself and go ahead.
Jun-Goo Kwak: Hi. Good morning, team. This is Jun-Goo on for Yas. Thanks for taking our questions. We have two. For the futility analysis later this year for ENSURE, how should we think about its implications upon readout? And what would be considered a win? And second, for the Phase II celiac study, where are you with finalizing the design? And could you provide more color on your interactions with the regulatory agencies so far?
Daniel Vitt: Give me a second. Yeah, thank you for the question. To the first question, I think, the nature of futility analysis is that you just want to get a proceed as planned answer from the committee. Or and this is one of the reasons, given that we have an event-driven endpoint, we would allow a reasonable sample size adjustment. That’s all we can get and then we then will implement into further development. So it’s a more binary thing, honestly, there. But we don’t expect any surprises given based on the Phase II data we obtained from the EMPhASIS studies in relapsing MS, we are very confident that this trial will also deliver comparable results. And I think all the calculations and assumptions were based on the Phase II EMPhASIS data. And the second question, maybe you can repeat it, was on regulatory interactions for PMS?
Jun-Goo Kwak: Celiac.
Daniel Vitt: For celiac. Yes, that’s work in progress right now. And also we are still working on the project on a clinical Phase II study design. There are a couple of thoughts which we’re running through. So as soon as there is something to report on, we will disclose that.
Jun-Goo Kwak: Right. Got it. Thank you so much.
Daniel Vitt: Thank you. Bye-bye.
Jessica Breu: Thank you. Next one in the queue here is William Wood from B. Riley. William, welcome. Please unmute yourself.
William Wood: Yes. Can you hear me?
Jessica Breu: Yes. Hello.
William Wood: Awesome. Thanks so much and congratulations on the quarter and thank you for taking our questions. Just thinking about your Phase III ENSURE, when should we expect to see the baseline characteristics for that trial and actually I’ll just leave it there.
Daniel Vitt: Good question. I don’t know exactly when we can disclose that and even we can get that because it’s a Phase III study. I think likely we need to wait for integrity of the study reasons until we unblind the study in 2026. So that’s the most likely case there, because quality first, and you don’t want to end up in difficult discussions with regulators just because we are — we want to know too early these kind of things. But we will have an eye on this and maybe more in the future if there is a way to get this information earlier.
William Wood: Got it. And actually, I do have two more. You also have two presentations at ACTRIMS forums coming up next week. Should we be expecting any additional data on your EMPhASIS interim results which have already been presented? And how should we view sort of the blocking of that EBV reactivation as being an important strategy in improving patient symptomology overall and what that can mean for your Phase II study in PMS? And I have one more.
Daniel Vitt: Yes. I think the second one is really the talking point from one of those posters, the EBV reactivation. This is something we got a little bit quiet the last couple of months regarding that because we were so excited about Nurr1, but it’s still true that vidofludimus calcium is a blocker of reactivation of EBV. And I think it’s still not fully understood how that could have a positive impact on disability, for example, prevention of disability, and how the full indication disease progression is influenced by reactivation of EBV in patients. There are a lot of hints for this. There’s a lot of work done by really great scientists here around the world, but also here, collaborators of ourselves. So I think that’s an interesting scientific flashlight on the third aspect of activity of vidofludimus calcium on one poster.
