MediciNova's COMBAT-ALS Trial: Progress and Promise for ALS Patients
Thursday, Dec 5, 2024 6:06 pm ET
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MediciNova, Inc., a biopharmaceutical company, recently presented an update and interim analysis of its Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) at the 35th International Symposium on ALS/MND. The presentation, titled "COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Interim Analysis Results," highlighted the progress made in the trial and the potential of MN-166 in treating ALS.
As of November 15, 2024, a total of 217 participants had been enrolled in the trial, with 183 participants assigned to either the MN-166 or placebo group. A pre-defined interim analysis was conducted to evaluate the correlation between 6-month and 12-month data and assess the 12-month double-blind phase trial design. The analysis revealed positive correlations between the 6-month and 12-month data for various metrics, including the Combined Assessment of Function and Survival (CAFS) score, modified CAFS score, and ALSFRS-R score. These correlations suggest that the trial's primary endpoints are on track, with consistent trends observed over time.

Positive correlations were also observed for Bulbar, Fine motor, and Gross motor scores, indicating that MN-166 may effectively slow the progression of ALS symptoms in these areas. Specifically, Bulbar scores relate to speech and swallowing, while Fine and Gross motor scores assess voluntary muscle movements. The strong correlations suggest that MN-166 might help maintain these crucial functions, which are often severely impacted by ALS. This could lead to improved quality of life and potentially extend survival time for patients.
The interim analysis results were reviewed and validated by an external independent Data Safety Monitoring Board (DSMB), which recommended that the trial continue as per the protocol. MediciNova's Chief Medical Officer and Director, Kazuko Matsuda, commented on the interim analysis, stating that the positive correlation between the 6-month and 12-month data supports the continuation of the trial with the current treatment plan. She also expressed optimism about the potential of these results in designing studies for rapidly progressing diseases like ALS.
The COMBAT-ALS trial is expected to complete patient assignments by June 2025, with trial results anticipated in 2026. MediciNova is also supporting continued treatment for patients who wish to continue MN-166 treatment after the 6-month open-label phase via the FDA's Expanded Access Program (EAP). Concurrently, a NIH-funded, large-scale Expanded Access Program trial is set to begin in 2025, providing access to MN-166 to more ALS patients.
The positive interim analysis results from MediciNova's COMBAT-ALS trial offer hope for ALS patients and their families. The strong correlations observed between 6-month and 12-month data suggest that MN-166 may have a sustainable effect on slowing ALS progression. As the trial continues, investors and the ALS community await the final results, which could potentially transform the treatment landscape for this devastating disease.