Core Insights - MediciNova, Inc. has successfully completed patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, for MN-166 (ibudilast) targeting Amyotrophic Lateral Sclerosis (ALS) with 234 patients randomized across two treatment arms [1][2][3] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a pipeline that includes 11 clinical programs [7] - The lead asset, MN-166 (ibudilast), is in late-stage clinical development for ALS and other neurodegenerative conditions, and has received Orphan Drug Designation and Fast Track Designation from the FDA [4][7] Clinical Trial Details - The COMBAT-ALS study is a randomized, double-blind, placebo-controlled trial assessing the efficacy, safety, and tolerability of MN-166 over a 12-month treatment period, followed by a 6-month open-label treatment period [2][3] - The primary endpoint is the Combined Assessment of Function and Survival (CAFS), with secondary endpoints including ALSFRS-R score progression and quality of life assessments, with top-line data expected by the end of 2026 [3] Drug Mechanism and Previous Results - MN-166 (ibudilast) is designed to modulate neuroinflammation and oxidative stress pathways, and has shown promising results in preclinical models and earlier Phase 1/2 studies, indicating a favorable safety profile [2][4] - The compound also targets multiple conditions, including progressive multiple sclerosis and glioblastoma, showcasing its broad therapeutic potential [6][7]