Immunic Announces Vidofludimus Calcium Reduced Risk of Disability Worsening by 30% in Primary Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial

Core Insights - Immunic, Inc. announced positive results from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS), showing a 20% reduction in the relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo [1][2][8] Clinical Efficacy - In the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24wCDW events by 20% compared to placebo, with a 30% reduction observed in the primary progressive multiple sclerosis (PPMS) subgroup (n=152) [2][8] - The drug also demonstrated a 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup (n=268) [2] - A consistent reduction in disability worsening was noted in patients without gadolinium-enhancing lesions at baseline, with a 29% reduction in 24wCDW events compared to placebo [4][8] MRI Endpoints - Vidofludimus calcium reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo, indicating a significant neuroprotective effect [5][16] - The total volume of new or enlarging T2 lesions showed a mean percent change of -0.22% for vidofludimus calcium versus +2.97% for placebo at month 24, highlighting the drug's efficacy in reducing lesion formation [6] Safety and Tolerability - The CALLIPER trial confirmed a favorable safety and tolerability profile for vidofludimus calcium, with treatment-emergent adverse events occurring in 69.4% of treated patients compared to 68.5% in the placebo group [9] - Serious adverse events were rare, observed in 8.1% of vidofludimus calcium-treated patients versus 6.5% in the placebo group, with no new safety signals identified [9] Future Directions - The company plans to advance vidofludimus calcium to a phase 3 registration study based on the positive results from the CALLIPER trial, particularly focusing on its potential as a neuroprotective treatment option for PMS [8][11] - Ongoing analysis of the full CALLIPER data set will be presented at upcoming scientific meetings, with the phase 3 clinical trial program for relapsing multiple sclerosis expected to be completed in 2026 [11][17]