MediciNova Completes Patient Enrollment In Phase 2/3 Clinical Trial, COMBAT-ALS For Treatment Of Amyotrophic Lateral Sclerosis

MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS). 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 (ibudilast) 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 (CAFS). 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 (FDA), as well as Orphan Designation from the European Medicines Agency (EMA).