MediciNova disclosed that its Phase 2b/3 COMBAT‑ALS trial of MN‑166 (ibudilast) has completed enrollment, with 234 patients randomized across 30 sites worldwide. The study reached its target cohort in September 2025, overcoming the enrollment slow‑down that plagued many trials during the COVID‑19 pandemic.
The COMBAT‑ALS trial is a randomized, double‑blind, placebo‑controlled study designed to evaluate MN‑166’s effect on functional decline and survival in patients with early‑stage amyotrophic lateral sclerosis. The primary endpoint is the change in the ALS Functional Rating Scale‑Revised (ALS‑FRS‑R) at 12 months, with secondary endpoints including forced vital capacity and time to tracheostomy or death. Top‑line data are expected by the end of 2026.
MediciNova’s MN‑166 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and an Orphan Designation from the European Commission, positioning the company for accelerated regulatory review if the trial results are favorable.
Chief Medical Officer Dr. Kazuko Matsuda highlighted the challenges of enrolling patients during the pandemic, noting that “slow enrollment, site restrictions, and uncertainty tested our resilience, but the dedication of investigators and study teams enabled us to meet our randomization goal.” President and CEO Dr. Yuichi Iwaki added that the company is supporting patients who wish to continue MN‑166 through the FDA’s Individual Patient Expanded Access Program and remains committed to expanding access as the trial progresses.
Analysts have maintained a “Buy” rating on MediciNova, citing the milestone of enrollment completion and the drug’s regulatory designations as key drivers of confidence. The company’s market reaction has been positive, reflecting investor enthusiasm for a potential ALS therapy that could fill a significant unmet need.
The enrollment milestone and regulatory designations strengthen MediciNova’s ALS pipeline and provide a clearer path toward potential commercialization. With a strong cash position and more cash than debt, the company is well positioned to fund the next phases of development and to capitalize on the anticipated top‑line data in 2026.
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