MediciNova Enrolls 100 Patients in ALS Study
MediciNova "announced that as of the end of January 2026, 12 sites in the US are activated and 100 patients have been enrolled in the SEANOBI study (Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS; NCT 06743776) representing 50% of the planned 200-enrollment, evaluating MN-166, or ibudilast, in patients with amyotrophic lateral sclerosis, or ALS. MN-166 (ibudilast) is also being evaluated in the COMBAT-ALS Phase 2b/3 trial, a randomized, placebo-controlled study assessing MN-166's efficacy and safety in ALS. 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."
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MediciNova Activates SEANOBI Study with 100 Patient Enrollments
- Patient Enrollment Progress: As of the end of January 2026, MediciNova has successfully enrolled 100 ALS patients across 12 sites in the U.S., achieving 50% of the planned 200 enrollments, marking significant progress in the clinical development of MN-166 and potentially accelerating the drug approval process.
- Funding Support: The SEANOBI Expanded Access Program is backed by a $22 million NINDS grant, designed to provide MN-166 treatment access to ALS patients not eligible for ongoing randomized trials while collecting crucial clinical and biomarker data, enhancing the drug's market competitiveness.
- Clinical Trial Design: MN-166 is also undergoing the COMBAT-ALS Phase 2b/3 randomized controlled trial, with 234 patients enrolled in the U.S. and Canada, and top-line results expected by the end of 2026, which will provide essential evidence for the drug's future approval.
- Strategic Implications: MediciNova's MN-166 has received Orphan Drug Designation from the FDA and EMA, along with Fast Track Designation from the FDA, and the combined clinical data from SEANOBI and COMBAT-ALS will offer more treatment options for ALS patients, addressing the urgent market demand for new therapies.
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