Zacks Small Cap Research – MNOV: MN-166 to be Evaluated in NIH-Sponsored Expanded Access Trial in ALS… – Technologist

By David Bautz, PhD

NASDAQ:MNOV

READ THE FULL MNOV RESEARCH REPORT

On September 30, 2024, MediciNova, Inc. (NASDAQ:MNOV) announced that MN-166 (ibudilast) will be evaluated in an Expanded Access Protocol (EAP) trial to evaluate its efficacy in patients with amyotrophic lateral sclerosis (ALS). The EAP is being supported through a $22 million grant from the National Institutes of Health (NIH) – Neurological Disorders and Stroke (NINDS) to an academic group lead by the Mayo Clinic. MediciNova will provide MN-166 drug product, regulatory support, and safety monitoring support.

Approximately 200 ALS patients will be enrolled and treated with MN-166 for six months with the primary outcome being an evaluation of its effect on blood levels of neurofilament light (NfL), which is a biomarker of neuron damage that has previously been shown to be prognostic of ALS disease progression (Gaiani et al., 2017).

Support for this program derives from the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), a bill signed into law by President Biden in December 2021. The bill called for a research grant program at NIH that utilizes the U.S. Food and Drug Administrations (FDA) EAP to evaluate experimental drugs for individuals that are not eligible for ALS clinical trials.

MN-166 is currently being evaluated in the Phase 2b/3 COMBAT-ALS trial. MediciNova recently announced two upcoming poster presentations that will provide an overview and update of the trial:

•     In October 2024, a poster will be presented at the 2024 Annual NEALS Meeting by lead Principal Investigator, Björn Oskarsson, MD, Associate Professor of Neurology

•     In December 2024, Dr. Oskarsson will present a poster at the 35th International Symposium on ALS/MND

Conclusion

The $22 million grant to evaluate MN-166 in an additional cohort of ALS patients shows the NIH is committed to opening access to experimental treatments to as many ALS patients as possible. We will be interested to see how MN-166 affects NfL levels, particularly given the increased focus on that biomarker in recent years and we look forward to updates on the trial as warranted. With no changes to our model our valuation remains at $10 per share.

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