Immunic Therapeutics CMO Dr Andreas Muehler joined Steve Darling from Proactive to share exciting news with Proactive regarding the company’s phase 3 ENSURE program, which is investigating its lead asset, vidofludimus calcium (IMU-838), for treating relapsing multiple sclerosis (RMS).
The company announced a favorable outcome of the interim futility analysis, conducted by an independent Data Monitoring Committee (IDMC), which recommended that the trials continue as planned, indicating that they are not futile. Muehler highlighted that Immunic remains blinded to the data, but the IDMC’s recommendation aligns with the company’s initial assumptions regarding the design, relapse rate, and powering of the ENSURE trials.
The committee's positive feedback supports the planned sample size and suggests that the trials are progressing in line with expectations, specifically concerning the primary endpoint of time to first relapse. The ENSURE program consists of two identical phase 3 trials, ENSURE-1 and ENSURE-2, involving around 1,050 adult RMS patients.
These randomized, double-blind studies are being conducted across more than 100 sites in over 15 countries, including the United States, India, and regions in Latin America, Central, and Eastern Europe. The trials are expected to be completed by 2026.