MediciNova Completes Patient Enrollment for Phase 2b/3 ALS Trial of MN-166

Reuters
2025/09/22
MediciNova Completes Patient Enrollment for Phase 2b/3 ALS Trial of MN-166

MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market and the Tokyo Stock Exchange, has announced the successful completion of patient enrollment in its Phase 2/3 COMBAT-ALS clinical trial. This trial is 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 clinical sites in the United States and Canada. The trial will assess the efficacy, safety, and tolerability of MN-166 over a 12-month treatment period, followed by a 6-month open-label treatment period. The primary endpoint of the trial is the Combined Assessment of Function and Survival $(CAFS)$, with secondary endpoints including ALSFRS-R score progression, muscle strength, and quality of life assessments. Top-line data from this study are expected to be available by the end of 2026. MN-166 has previously shown promising results in earlier studies and has received Orphan Drug and Fast Track Designations from the U.S. FDA, as well as Orphan Designation from the EMA.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. MediciNova Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9532700-en) on September 22, 2025, and is solely responsible for the information contained therein.

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