MediciNova Announces 100 Patients Enrolled in SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN-166 (ibudilast) in ALS patients

Executive Summary

• MediciNova reports that the NIH‑funded SEANOBI Expanded‑Access Program (EAP) has activated 12 U.S. sites and enrolled 100 ALS patients, reaching 50 % of its planned 200‑patient enrollment.
• The program is supported by a $22 million NINDS grant and will generate real‑world clinical and biomarker data to complement the ongoing COMBAT‑ALS Phase 2b/3 trial.
• Both programs together are positioned to provide regulatory‑supporting evidence for MN‑166 (ibudilast), which already holds Orphan Drug Designation (FDA & EMA) and Fast Track Designation (FDA).

Key Details

• SEANOBI EAP enrollment: 100 patients enrolled as of end‑January 2026; target is 200 patients across the 12 active sites.
• Funding: $22 million grant from NINDS under the ACT for ALS initiative.
• Program purpose: Provide MN‑166 (ibudilast) to ALS patients ineligible for randomized trials while collecting clinical outcomes and neurofilament biomarker data.
• COMBAT‑ALS trial status: Ongoing Phase 2b/3, 234 patients randomized in the U.S. and Canada; top‑line results expected by end of 2026.
• Regulatory designations for MN‑166: Orphan Drug Designation (U.S. FDA & EU EMA) and Fast Track Designation (U.S. FDA) for ALS.
• CEO comment (Dr. Yuichi Iwaki): Highlights the significance of reaching 100 enrollments, gratitude to patients/families, and the combined data from SEANOBI and COMBAT‑ALS as a stronger basis for regulatory discussions.

Notable Quotes

“Achieving 100 enrolled patients in the NIH‑funded SEANOBI Expanded‑Access Program marks substantial progress in the clinical development of MN‑166… Together with our COMBAT‑ALS study, SEANOBI brings forward both clinical and real‑world evidence that will support discussions with regulators.” – Dr. Yuichi Iwaki, President & CEO

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