MediciNova completes patient enrollment in COMBAT-ALS Phase 2b/3 trial

MediciNova (MNOV) announced completion of patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, evaluating MN-166 for the treatment of Amyotrophic Lateral Sclerosis. A total of 234 patients have been randomized across two treatment arms at multiple clinical sites in the United States and Canada. Patient recruitment is now officially closed. MN-166 is an orally administered small molecules designed to modulate neuroinflammation and oxidative stress pathways implicated in ALS progression. The COMBAT-ALS study is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety, and tolerability of MN-166 over a 12-month treatment period followed by 6-month open-label treatment period. The trial’s primary endpoint is the Combined Assessment of Function and Survival. Secondary endpoints include ALSFRS-R score progression, muscle strength measured by hand-held dynamometry, and quality of life assessments. Top-line data are expected by the end of 2026. MN-166 has previously demonstrated promising results in preclinical models and earlier Phase 1/2 and Phase 2 studies, showing a favorable safety profile and a higher proportion of treatment responders among MN-166-treated patients. The compound has received Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration, as well as Orphan Designation from the European Medicines Agency.