- Immunic (IMUX, Financial) completes enrollment for Phase 3 ENSURE trials in relapsing multiple sclerosis.
- Phase 2 CALLIPER trial data shows vidofludimus calcium reduces disability worsening in progressive MS.
- Vidofludimus calcium demonstrates significant neuroprotective and anti-inflammatory effects.
Immunic, Inc. (IMUX) has achieved two significant milestones in its clinical program for multiple sclerosis (MS). The company has successfully completed enrollment for both its Phase 3 ENSURE trials of vidofludimus calcium in relapsing MS. A total of 2,221 patients have been randomized, with 1,121 patients in ENSURE-1 and 1,100 in ENSURE-2. Top-line data for these trials is expected by the end of 2026.
The Phase 2 CALLIPER trial in progressive MS revealed promising results, demonstrating vidofludimus calcium's potential to reduce confirmed disability worsening over 24 weeks (24wCDW). Specifically, there was a 24% reduction in the overall progressive MS population, with significant reductions observed in sub-populations: 33% in primary progressive MS (PPMS) patients, 19% in non-active secondary progressive MS (naSPMS) patients, and 34% in active secondary progressive MS (aSPMS) patients.
Vidofludimus calcium, as a Nurr1 activator, has shown efficacy regardless of the presence of inflammatory lesions. This suggests broader therapeutic potential due to its dual mechanism of action, offering both neuroprotective and anti-inflammatory effects. With the consistent findings across multiple MS subtypes, Immunic is bolstered in its objective to advance to Phase 3 in progressive MS while proceeding with its relapsing MS program towards potential regulatory submission.
