Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt talked with Proactive about the company’s second quarter highlights, with a particular focus on clinical progress in its multiple sclerosis (MS) programs.
The headline development was the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, Immunic’s lead asset.
Vitt noted a 24% reduction in disability progression across the full study population, with over 30% reduction seen in patients with primary progressive MS.
Proactive: Hello you're watching Proactive, I'm joined by Immunic Inc CEO Dr Daniel Vitt. Daniel, very good to speak with you. You're out with your second quarter results. One of the highlights is a promising result from your phase two CALLIPER trial of vidofludimus calcium. Can you remind us about that?
Dr Daniel Vitt: Yeah. Hi. Good morning. Happy to be here today. Yeah, I think it was a busy quarter. And as you said, one of the most important things was the readout of our CALLIPER study. This goes back years ago when we thought, how can we analyze the neuroprotective effect of vidofludimus calcium in patients—specifically addressing the unmet need of patients with progressive forms of multiple sclerosis?
We initiated the CALLIPER study. We are very pleased to see that with this study, we achieved a very profound numerical reduction of disability progression in these patients. Overall, we saw a 24% reduction of confirmed disability progression in the full ITT set. What I like specifically is that more than 30% of patients with primary progressive MS also had a lower risk of progression. I think that confirms the mode of action of the drug and underlines the ability of vidofludimus calcium to slow down progression in MS patients.
Daniel, what does this data mean for vidofludimus calcium and MS overall?
As I said, it is important everywhere in multiple sclerosis. We need to stop progression. This is the key unmet medical need in these patients. Therefore, I think the CALLIPER data is important for primary progressive MS, secondary progressive MS, and also for relapsing MS. We have the phase three ENSURE studies ongoing, and those patients will also benefit from the neuroprotective features of vidofludimus calcium.
You mentioned the phase three ENSURE trials. You completed enrollment for both trials of vidofludimus calcium in relapsing MS. What's the latest there?
Yeah, also a big milestone in the quarter. We finally made it and fully enrolled the studies with 1,100 and 1,121 patients in the two ENSURE studies, respectively. These are twin studies and are now fully enrolled. So we now know the studies will read out next year. It's a big step. It's a huge study—2,200 patients in total. There's a huge unmet medical need, and I think patients deserve new treatment options. With this, we come a very significant step closer to the readouts.
Moving on to the phase two EMPhASIS trial. You released new data in June. Can you recap what that revealed?
That also points to the same thing as the CALLIPER study results. The question is always: to what extent can we protect patients from disability progression? We were able to follow up with patients from the EMPhASIS study, which we completed years ago. Some patients are now on treatment for more than five years in the open-label extension part of the study.
These patients received 30 mg of vidofludimus calcium for quite a long time. The good thing is that more than 90% of the patients after 144 weeks of treatment are free of disability progression. Looking back on historic trials and comparisons with other molecules, that’s very convincing activity. Also, the patients seem to like the drug—many stayed on treatment for years, and the discontinuation rate is really low. That speaks to the quality of the program and the perceived quality of the treatment from the patients’ point of view.
Another highlight of the quarter, you strengthened your balance sheet with two financings. So you are well positioned to take those trials forward, aren't you?
Absolutely. In this market environment these days, it's a big success to convince investors to support the company, to believe in the CALLIPER data and the ENSURE data, and in our ability to bring it to the finish line—either alone or with a partner. This capital raise was important to bring us into a position to go forward with these developments, specifically the completion of the phase three studies in relapsing MS.
Quotes have been lightly edited for clarity and style