Core Insights - MediciNova, Inc. has achieved significant progress in its SEANOBI study for MN-166 (ibudilast), with 100 patients enrolled, representing 50% of the target enrollment of 200 patients [1][2] - The SEANOBI Expanded-Access Program is funded by a $22 million grant from NINDS under the ACT for ALS initiative, aimed at providing treatment access to ALS patients not eligible for clinical trials while collecting valuable clinical data [2][4] - MN-166 is also being evaluated in the COMBAT-ALS Phase 2b/3 trial, with top-line results expected by the end of 2026 [3][5] SEANOBI Study - The SEANOBI study is designed to evaluate MN-166 in ALS patients and aims to enroll approximately 200 patients across 12 active sites [4] - The program focuses on generating real-world clinical outcomes and biomarker data, including neurofilament levels, to support future regulatory discussions [2][4] COMBAT-ALS Trial - The COMBAT-ALS trial is a randomized, placebo-controlled study assessing the efficacy and safety of MN-166, with 234 patients enrolled in the U.S. and Canada [3][5] - The trial includes a 12-month double-blind period followed by a 6-month open-label extension, with results anticipated by the end of 2026 [3][5] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a late-stage pipeline including MN-166 and MN-001 [8] - MN-166 has received Orphan Drug Designation from the FDA and EMA, as well as Fast Track Designation from the FDA for ALS treatment [7][8]
MediciNova Announces 100 Patients Enrolled in SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN‑166 (ibudilast) in ALS patients