Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt talked with Proactive about the company’s major milestones in 2025 and key expectations for 2026.
He highlighted the significance of the phase 2 CALLIPER study, which demonstrated a 31% reduction in confirmed disability worsening in patients with progressive multiple sclerosis (MS), and a 34% reduction in those without baseline gadolinium lesions. According to Vitt, this points to a “neuroprotective effect” of vidofludimus calcium.
He also noted consistent long-term results from the EMPhASIS study, where 92.3% of relapsing-remitting MS patients remained free of 12-week confirmed disability worsening after 144 weeks. Only 13.8% of disability events were independent of relapses, supporting the drug’s potential effect on progression regardless of relapse activity.
Beyond MS, Vitt said Immunic has strengthened its patent position, with potential exclusivity to 2041 in key markets. He also discussed early findings on IMU-856 in celiac disease, which showed increases in natural GLP-1 levels—suggesting gut health benefits and potential links to weight management.
Proactive: Hello, you're watching Proactive. I'm joined by Immunic CEO Dr Daniel Vitt. Daniel, very Happy New Year to you. 2025 was a busy year for Immunic. If you had to sum it up, what were the most important clinical milestones that moved the company forward?
Dr Daniel Vitt: Happy New Year, as well. 2025 was an exciting year for us, specifically following the data readout of our phase 2 clinical study — the CALLIPER study — in patients with progressive MS. Simply put, we saw a 31% reduction in confirmed disability worsening in primary progressive MS patients.
Most importantly, there was a 34% reduction in confirmed disability worsening in those patients without baseline gadolinium lesions. This suggests the drug has a neuroprotective effect, which is amazing and a real step forward for all patients suffering from multiple sclerosis.
Looking at that phase 2 CALLIPER data, why is it particularly significant for the future of MS treatment?
MS patients’ biggest issue is the worsening of disability over time, which is driven by two processes — one inflammatory and one independent of inflammation. Vidofludimus calcium, through Nurr1 activation, has the potential to address both. The CALLIPER study showed that it can slow disability progression independent of relapse activity, which benefits even patients with relapsing forms of MS.
You also reported long-term open-label extension data from EMPhASIS in relapsing-remitting MS, with most patients free of disability worsening after several years. What does that tell you about vidofludimus calcium’s long-term potential?
There’s a connection between the CALLIPER and EMPhASIS results. After 144 weeks, 92.3% of patients remained free of 12-week confirmed disability worsening. From 29 total events during that time, only four — 13.8% — were progression independent of relapse activity. That suggests vidofludimus calcium significantly reduces PIRA in relapsing-remitting MS patients.
Beyond MS, you strengthened the patent position for vidofludimus calcium and shared intriguing GLP-1 findings for IMU-856, with possible applications in both celiac disease and weight management. How do these developments broaden Immunic’s strategic opportunities?
Patent longevity is key. With PMS patents potentially running to 2041, we have a strong window of exclusivity — possibly 12 to 14 years in major MS markets. On IMU-856, we saw interesting findings in a phase 1 study in celiac disease patients. The biomarker data showed a dose- and time-dependent increase in natural GLP-1 levels. That supports gut health’s relevance and may open other areas such as weight management.
Looking ahead to 2026, enrollment in the phase 3 ENSURE trials is complete. Top-line data expected by the end of the year. What should investors and patients be watching for from that readout?
This is the most important data for Immunic and for patients, given the unmet need in MS. With hundreds of thousands of untreated patients and a market expected to grow to 30 billion US dollars by 2030, this phase 3 readout — from 2,221 patients in the ENSURE-1 and ENSURE-2 trials — is a big step toward FDA submission and potential market launch.
What else could make 2026 transformative for Immunic?
It all centres on the phase 3 data. We’re already preparing for an NDA submission. The team is also working toward a commercial launch in 2028, assuming FDA approval, and later approvals in Europe. Everything right now is focused on that. Of course, we have other research ongoing, and we’ll keep the market informed if anything new arises.
Quotes have been lightly edited for style and clarity