Immunic Inc (NASDAQ:IMUX)’s chief medical officer Dr Andreas Muehler talked with Proactive about the successful completion of patient enrollment for its Phase 3 ENSURE program targeting relapsing multiple sclerosis (MS).
The ENSURE-1 and ENSURE-2 trials, described as "twin studies," have collectively enrolled over 2,000 patients across 15 countries.
Dr Muehler also provided insight into new secondary endpoint data from the Phase 2 CALLIPER trial for progressive MS.
Proactive: Hello and welcome to Proactive. I'm joined today by Dr Andreas Muehler, Chief Medical Officer of Immunic. Dr. Muehler, great to have you back.
Dr Andreas Muehler: Great to be here again.
Let's start with the recent milestone: Immunic has completed enrollment in the Phase 3 ENSURE program for relapsing MS. Tell us more.
Absolutely. The ENSURE program consists of two Phase 3 trials—ENSURE-1 and ENSURE-2. Both are placebo-controlled and designed to evaluate vidofludimus calcium for relapsing MS. We’re very excited to share that both trials have completed patient enrollment with over 2,000 patients across 15 countries.
That’s a large and diverse group. How significant is this milestone?
It's huge. These are pivotal trials, and completing enrollment means we can now move into the follow-up phase and anticipate top-line data around the end of 2025. It also speaks to our strong clinical operations team, who managed global recruitment with high quality and speed.
You also released secondary endpoint data from the CALLIPER trial for progressive MS. What can you share?
The CALLIPER trial is evaluating vidofludimus calcium for progressive MS, focusing particularly on neuroprotection. We recently reported new secondary endpoint data: in the 45 mg dose group, there was a 24% reduction in the risk of 24-week confirmed disability worsening. That’s very promising.
How does this impact the perception of vidofludimus calcium?
It supports our hypothesis that the drug not only has anti-inflammatory effects but may also offer neuroprotection. This dual mechanism could position it as a differentiated therapeutic candidate in the MS space.
Any signals on safety or tolerability?
Thus far, the safety and tolerability profiles have been consistent with what we saw in earlier phases. That consistency is crucial for long-term treatment in chronic diseases like MS.
What's next?
We’re now following up with patients in the ENSURE program to prepare for final analyses. We’ll also continue analyzing CALLIPER data. The goal is to provide a new, effective, and safe treatment for all MS patients.
Quotes have been lightly edited for clarity and style