Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt talked with Proactive about the company’s third quarter highlights, with a particular focus on the progress of its oral MS treatment, vidofludimus calcium.
Dr Vitt noted the company had a strong presence at the 2025 ECTRIMS conference, presenting important new data from several clinical studies.
These included results from the CALLIPER study, which showed a statistically significant effect on confirmed disability improvement, and promising data in primary progressive MS patients showing a numerical benefit in slowing disability worsening.
He also referenced findings from the EMPhASIS phase 2 open-label extension trial. According to Vitt, “144 weeks later, still 92.3% of the patients were free of 12-week confirmed disability worsening,” highlighting the durability of the drug’s effects and its favorable safety and tolerability profile.
Discussing the upcoming ENSURE phase 3 trials in relapsing MS, Vitt explained the company is targeting statistically significant results on the primary endpoint of time to first relapse, with topline data expected in 2026. Secondary endpoints aim to confirm the drug’s neuroprotective potential.
He also pointed to recently granted US patents, which strengthen commercial protection for vidofludimus calcium in both relapsing and progressive MS, potentially extending exclusivity beyond 2041.
Proactive: Hello you're watching Proactive. I'm joined by Dr Daniel Vitt, he's the CEO of Immunic. Daniel, very good to speak with you. You're out with your third quarter results, and one of the highlights of the period was your strong presence at ECTRIMS. What were the key takeaways for investors from the conference about vidofludimus calcium's potential in multiple sclerosis?
Dr Daniel Vitt: Thank you. ECTRIMS is one of the highlights for Immunic this year. We had a strong presence at the conference because this is the core of our research. We have the phase three ENSURE studies ongoing, which are reading out next year in relapsing MS. We presented a lot of data at ECTRIMS, specifically from our CALLIPER study.
One highlight was a statistically significant effect on confirmed disability improvement in patients. It’s a very nice signal. We also presented data for our subgroup of primary progressive MS. The molecule showed extraordinarily good data, especially looking at the numerical benefit on slowing disability worsening.
Another important data point we presented was from the open-label extension of our EMPhASIS trial — our completed phase two study in relapsing MS patients. We now have data from the open-label extension involving 254 patients. At 144 weeks, 92.3% of those patients were free of 12-week confirmed disability worsening. That’s outstanding and shows how effective the treatment is at slowing disability progression.
Just touching on the EMPhASIS open-label extension in relapsing MS — how do these findings reinforce confidence in vidofludimus calcium as an oral treatment option?
There are two key aspects. First, the outstanding safety and tolerability. There are many discussions around the side effects of other drugs, but our data shows patients appreciate this treatment. Dropout rates are very low, even in the open-label extension, which ran for 144 weeks. That’s a long time and reflects positively on the molecule’s safety profile.
Second, the effect on slowing disability progression — consistent with what we observed in the CALLIPER study. The rate of patients experiencing disability worsening is also low in this study. Together, it underlines the neuroprotective potential of the molecule.
Your twin phase three ENSURE trials in relapsing MS are on track for topline data in 2026. What are the main goals of those studies and what should investors look for?
The primary goal is to complete the studies with a statistically significant outcome on the primary endpoint — time to first relapse. That’s essential to achieve drug approval.
Medically, the bigger picture is about offering a unique, oral treatment with a strong safety and risk-benefit profile. This could change how we treat multiple sclerosis. Secondary endpoints are designed to confirm the drug’s effect on slowing disability progression, as seen in CALLIPER, EMPhASIS and even in our preclinical studies. We believe this is linked to activation of the Nurr-1 protein — a new mechanism with neuroprotective potential.
You recently received new US patents covering progressive MS dose strengths. How does this strengthen vidofludimus calcium’s commercial position?
It’s a positive development. We already have a broad set of patents and expect several to be listed in the Orange Book. This latest patent covers progressive MS, complementing our coverage for relapsing MS. Together, these patents underline the broad protection of the asset and help secure market exclusivity beyond 2041.
What should investors be looking out for in the coming months?
The most important milestone is the phase three data readout from the ENSURE studies at the end of next year. It’s a big step for the company and for MS patients globally. We also continue discussions with potential partners for launching the product. It’s an exciting time for Immunic — and hopefully for our shareholders too.
Quotes have been lightly edited for clarity and style