First Patient Enrolled in NIH-Funded Expanded Access Program (EAP) Trial to Evaluate MN-166 in Amyotrophic Lateral Sclerosis (ALS) Patients

Core Insights - MediciNova, Inc. has initiated the enrollment of the first patient in the NIH-funded Expanded Access Program (EAP) trial for MN-166 (ibudilast) aimed at patients with Amyotrophic Lateral Sclerosis (ALS) [1][2] - The EAP trial will assess the safety and efficacy of MN-166 in approximately 200 ALS patients who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial [2][3] - MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, currently in late-stage clinical development for various neurodegenerative diseases [4] Company Overview - MediciNova 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 [5] - The lead asset, MN-166 (ibudilast), is in Phase 3 trials for ALS and degenerative cervical myelopathy (DCM) and is ready for Phase 3 for progressive multiple sclerosis (MS) [5] - MediciNova has received Orphan Drug Designation for MN-166 in ALS from the U.S. FDA and EU EMA, and it has also been granted Fast Track Designation by the FDA for ALS treatment [4][5]