MediciNova Presents Study Update and Interim Analysis of Phase 2/3 Clinical Trial of MN-166 (ibudilast) in ALS (COMBAT-ALS Clinical Trial) at the 35th International Symposium on ALS/MND

Core Insights - MediciNova, Inc. announced the interim analysis results from the COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS), which will be presented at the 35th International Symposium on ALS/MND [1][2] Study Update - As of November 15, 2024, 217 participants have been enrolled in the trial, with 183 assigned to either the MN-166 or placebo group [2] - The interim analysis showed positive correlations between 6-month and 12-month data for various scores, including CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69) [2] - The Data Safety Monitoring Board (DSMB) reviewed the interim results and recommended the continuation of the trial as per the protocol [2][3] Future Expectations - The company expects to complete patient assignments by June 2025, with trial results anticipated in 2026 [3] - An NIH-funded large-scale Expanded Access Program trial is set to begin next year, aiming to provide access to MN-166 for more ALS patients [3] Product Information - MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, currently in late-stage clinical development for ALS and other neurodegenerative diseases [4] - The compound is also being evaluated for conditions such as progressive multiple sclerosis, glioblastoma, Long COVID, and substance use disorder [4] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company with a late-stage pipeline of novel small molecule therapies targeting inflammatory, fibrotic, and neurodegenerative diseases [5] - The company has 11 programs in clinical development, with MN-166 being the lead asset currently in Phase 3 for ALS and DCM [5]