Immunic, Inc. announced the presentation of additional data from its Phase 2 CALLIPER trial for its lead asset, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). The data, presented at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, reinforces the drug's potential by showing a favorable safety profile and positive effects on disability metrics compared to placebo.
Key Details
- Primary Asset: Vidofludimus calcium (IMU-838), an oral Nurr1 activator being evaluated for progressive multiple sclerosis.
- Favorable Safety Profile: Over 120 weeks, the incidence of treatment-emergent adverse events was comparable to placebo (69.4% vs. 68.5%), with identical discontinuation rates (2.6%).
- Disability Metrics: A novel post-hoc statistical analysis, designed to capture both disability worsening and improvement, showed results that consistently favored vidofludimus calcium over placebo.
- Patient-Reported Outcomes: The trial data showed no negative impact on patient mood and numerically favored the drug in perceived treatment effectiveness compared to placebo.