Immunic完成了维多氟莫司钙治疗复发性多发性硬化症的两项III期ENSURE试验的入组;预计2026年底发布一线数据

– Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 –

– Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential –

– New CALLIPER Data Regarding Time to 24-Week Confirmed Disability Worsening Shows Substantial and Medically Relevant Reductions for Vidofludimus Calcium Over Placebo in the Overall Study Population and Major Disease Subtypes –

NEW YORK, June 5, 2025 /PRNewswire/ -- Immunic, Inc. (NASDAQ:IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced the completion of enrollment for both phase 3 ENSURE trials of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing multiple sclerosis and additional phase 2 CALLIPER trial data in patients with progressive multiple sclerosis underlining the recently released positive top-line results.

Enrollment Completed for Both Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis (RMS)

The ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa (MENA) region, Latin America, and Central and Eastern Europe. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo. The primary endpoint for both trials is time to first relapse up to 72 weeks. Secondary endpoints include time to confirmed disability worsening based on the Expanded Disability Status Scale (EDSS), volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and magnetic resonance imaging (MRI)-based endpoints.