MediciNova reaches 200-patient enrollment in NIH-funded ALS study

MediciNova, Inc. (NASDAQ: MNOV) announced that the SEANOBI-ALS expanded access study evaluating MN-166 (ibudilast) in patients with amyotrophic lateral sclerosis has reached its target enrollment of 200 patients.

The study, funded by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health under the ACT for ALS program, is designed to provide MN-166 to ALS patients who are not eligible to participate in ongoing randomized clinical trials. Final patient follow-ups are projected to conclude in early 2027, after which a data analysis phase will begin to support scientific presentations and peer-reviewed publications led by an academic investigator.

MN-166 (ibudilast) is an orally available small-molecule inhibitor of phosphodiesterase-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). The compound holds Orphan Drug Designation from the U.S. FDA and the EU EMA for ALS, as well as Fast Track Designation from the FDA for ALS treatment.

MediciNova separately announced in September 2025 that it completed enrollment in its COMBAT-ALS Phase 2b/3 clinical trial of MN-166.

Yuichi Iwaki, President and CEO of MediciNova, said the enrollment milestone reflects the partnership of patients, families, and the NIH, adding that the company remains "entirely focused on executing the remaining protocol steps with the utmost urgency and care."

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