03-01-2026

MediciNova announced that its SEANOBI study evaluating MN-166 in patients with amyotrophic lateral sclerosis has enrolled 50% of the planned 200 participants.

SEANOBI (The Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS ) program is a U.S.based initiative funded by a $22 million National Institute of Neurological Disorders and Stroke (NINDS)/National Institutes of Health(NIH) grant under Accelerating Access to Critical Therapies(ACT) for ALS, designed to provide MN 166 (ibudilast) to individuals living with ALS who are not eligible for ongoing randomized clinical trials.

MN-166 (ibudilast) is an orally available small molecule compound that inhibits phosphodiesterase type-4 and inflammatory cytokines, including macrophage migration inhibitory factor.

A Phase 2b/3 trial assessing MN 166’s efficacy and safety in ALS, dubbed COMBAT ALS, is also ongoing.

The study includes a 12-month double-blind period followed by a 6-month open-label extension, with 234 patients enrolled in the U.S. and Canada. Top-line results are expected by the end of 2026.

Amyotrophic lateral sclerosis (ALS), formerly known as Lou Gehrig’s disease, is a neurological disorder that affects motor neurons. Motor neurons are the nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing.

In addition, MN-166 is also in development for glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy, and substance use disorder.

MediciNova’s MN-166 received Orphan Drug Designation in ALS by the U.S. FDA and the European Medicines Agency (EU EMA), in addition to Orphan Drug Designation for yet another indication, Glioblastoma.

Source:RTTNews