MediciNova Inc., a biopharmaceutical company specializing in neurodegenerative disease treatments, has completed the double-blind portion of the COMBAT-ALS Phase 2b/3 clinical trial for its lead candidate, MN-166 (ibudilast). The study, which randomized 234 participants across clinical sites in the United States and Canada, evaluated the drug’s efficacy, safety, and tolerability over a 12-month period. Participants are now continuing into a 6-month open-label extension phase, during which active treatment continues. MN-166 is an orally administered small molecule designed to target neuroinflammation and oxidative stress pathways in amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder. The trial’s primary endpoint was the Combined Assessment of Function and Survival, with secondary endpoints including changes in the ALS Functional Rating Scale-Revised, muscle strength via hand-held dynamometry, and quality-of-life assessments.
The drug has received regulatory designations from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including Fast Track and Orphan Drug designations. Topline results from the double-blind phase are expected by the end of 2026, with the final patient visit scheduled for March 2027. Yuichi Iwaki, President and CEO of MediciNova, noted the milestone as a key step toward advancing MN-166’s potential pathway to regulatory approval. The company remains focused on delivering meaningful outcomes for patients with ALS, a disease with limited therapeutic options.
MediciNova operates under dual listings on the NASDAQ and the Tokyo Stock Exchange (code 4875), with its headquarters in La Jolla, California. The trial’s completion underscores the company’s commitment to advancing its pipeline in neurodegenerative diseases, where MN-166 represents a promising therapeutic approach.
