2026 New Year's Greetings from the CEO
Executive Summary
- Completed patient enrollment for three MediciNova clinical trials in 2025, positioning the company to generate pivotal data in 2026.
- Launched a large‑scale Expanded Access Program for ALS supported by a $22 million NIH grant, with 87 patients enrolled across 12 U.S. sites as of Dec 15, 2025.
- Provided timelines for upcoming top‑line results: COMBAT‑ALS (Phase 2b/3) expected by year‑end 2025; MN‑001‑NATG‑202 (Phase 2) data anticipated summer 2026.
Key Details
- MN‑166 (ibudilast) – COMBAT‑ALS Study (Phase 2b/3, ALS):
- Patient enrollment completed September 2025.
- Double‑blind treatment period runs 12 months; last participant to finish by late 2025.
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Data analysis will commence thereafter with top‑line results targeted for year‑end 2025.
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Expanded Access Program for ALS:
- Initiated March 2025, funded by a $22 million NIH research grant.
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As of Dec 15, 2025: 12 U.S. sites active; 87 patients enrolled.
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MN‑166 – OXTOX Study (Phase 2b, chemotherapy‑induced peripheral neuropathy):
- Enrollment completed December 2025.
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Participants will remain on treatment until disease progression or discontinuation criteria are met.
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MN‑001 (tipelukast) – MN‑001‑NATG‑202 Study (Phase 2, hypertriglyceridemia/NAFLD/T2DM):
- Enrollment completed November 2025.
- Top‑line data expected summer 2026.
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Recent academic collaboration identified a novel mechanism whereby MN‑001 and its metabolite MN‑002 modulate cholesterol and lipid metabolism, reinforcing development rationale.
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Future Outlook (2026):
- Company expects to leverage completed enrollments to file regulatory submissions pending positive trial outcomes.
- Continued focus on advancing both MN‑166 and MN‑001 pipelines toward pivotal approvals.
Notable Quotes
“The year 2025 was marked by global uncertainty… Despite these challenges, MediciNova achieved significant milestones…” – Yuichi Iwaki, President & CEO
All forward‑looking statements are subject to risks and uncertainties detailed in the release.