Immunic Reports Positive Interim Results for Phase 3 ENSURE Program

Immunic AG announced favorable interim results from its Phase 3 ENSURE program assessing vidofludimus calcium in relapsing multiple sclerosis. The Independent Data Monitoring Committee (IDMC) confirmed that the study's futility criteria were not met, supporting the continuation of trials without modification. The program remains on track for completion in 2026.

Vidofludimus calcium shows potential as an oral treatment for MS, attributed to its neuroprotective and anti-inflammatory properties. The ENSURE program comprises two identical trials, ENSURE-1 and ENSURE-2, across more than 100 global sites. The primary goal is to measure time to first relapse over 72 weeks.

The next milestone will be the Phase 2 CALLIPER trial results in April, potentially establishing vidofludimus calcium as a pioneering oral treatment for progressive MS. Immunic's CEO, Daniel Vitt, emphasized the significance of the interim results in steering towards regulatory approval.