- MediciNova (MNOV, Financial) enrolls the first patient in a new trial for ALS treatment.
- The trial, funded by the NIH, will assess MN-166 in approximately 200 patients.
- Focuses on ALS patients who are ineligible for the ongoing COMBAT-ALS trial.
MediciNova, Inc. (MNOV), a biopharmaceutical firm listed on NASDAQ, has successfully enrolled the first patient in an NIH-funded Expanded Access Program (EAP) trial aimed at evaluating the efficacy and safety of MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS). This trial marks a significant step in expanding treatment access to roughly 200 ALS patients who are not eligible for the company's ongoing Phase 2/3 COMBAT-ALS trial.
This initiative, supported by the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), seeks to identify effective therapeutic options for individuals in advanced stages of ALS, specifically those who cannot participate in the current COMBAT-ALS study.
Dr. Yuichi Iwaki, President and CEO of MediciNova, expressed gratitude to NIH and NINDS for their support, as well as to the trial participants, their families, and healthcare providers. He underscored the importance of this trial in advancing ALS treatment options.
MN-166 (ibudilast) is an orally administered molecule under investigation for several neurodegenerative disorders, including ALS. It has received Fast Track Designation by the FDA for ALS treatment and Orphan Drug Designation from both the U.S. FDA and EU EMA.
MediciNova continues to progress its diverse late-stage pipeline, with MN-166 poised for advancement in additional indications such as progressive multiple sclerosis (MS), degenerative cervical myelopathy (DCM), and potentially extending to conditions like Long COVID and substance use disorder.
