By David Bautz, PhD
READ THE FULL MNOV RESEARCH REPORT
Business Update
Encouraging Interim Results from Phase 2b/3 COMBAT-ALS Trial
On December 5, 2024, MediciNova, Inc. (NASDAQ:MNOV) announced a poster presentation at the 35th International Symposium on ALS/MND would feature a study update and interim analysis results from the ongoing Phase 2b/3 COMBAT-ALS trial of MN-166 (ibudilast).
As of November 15, 2024, the trial has enrolled a total of 217 participants and 183 participants have been randomly assigned to treatment with either placebo or MN-166. A pre-defined interim analysis was performed to evaluate the correlation between the 6-month and 12-month data as well as assessing the 12-month double blind phase trial design. A correlation analysis was performed on the (CAFS) scores, modified CAFS scores, and ALSFRS-R scores at six and 12 months.
There was a positive correlation for the 6- and 12-month data for CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). The numbers in parentheses represent Spearman Rank Correlation coefficients, which indicates the strength and direction between two sets of data. In practical terms, a coefficient of 0.7 indicates a strong, positive correlation. Positive correlations were also seen for Bulbar score (0.74), fine motor score (0.71), and gross motor score (0.67), however no correlation was seen for respiratory score. Overall, these data support the company’s use of a 12-month, double blind trial design. This was further validated by the Data Safety Monitoring Board (DSMB), which reviewed the data and recommended that the trial continue as per protocol.
Based on the current enrollment rate, we estimate that the trial will be fully enrolled by mid-2025, which would lead to release of topline results in 2026.
In addition to the COMBAT-ALS trial, we anticipate the initiation of an Expanded Access Protocol (EAP) trial to evaluate the effect of MN-166 treatment on blood levels of neurofilament light (NfL) in patients with ALS in 2025. That trial is being supported by a $22 million grant from the National Institutes of Health (NIH) – Neurological Disorders and Stroke (NINDS) with MediciNova providing drug product, regulatory support, and safety monitoring support.
Conclusion
The encouraging update on the Phase 2b/3 COMBAT-ALS trial is a good sign for the company as it moves to finish enrollment in the trial by mid-2025. It’s not possible to draw any conclusions regarding the efficacy of MN-166 from the data, however a positive correlation between the 6- and 12-month data is indicative that it will be a robust data set. Assuming the trial can be fully enrolled by mid-2025 we anticipate topline results in 2026. With no changes to our model, our valuation remains at $10 per share.
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