LA JOLLA, Calif. — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that as of the end of January 2026, 12 sites in the US are activated and 100 patients have been enrolled in the SEANOBI study (Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS; NCT 06743776) representing 50% of the planned 200-enrollment, evaluating MN‑166 (ibudilast) in patients with amyotrophic lateral sclerosis (ALS).
Dr. Yuichi Iwaki, President and CEO of MediciNova, commented: “Achieving 100 enrolled patients in the NIH‑funded SEANOBI Expanded‑Access Program marks substantial progress in the clinical development of MN‑166. We are deeply grateful to the patients and families who chose to participate in SEANOBI, as their commitment makes this important program possible. We also sincerely appreciate the continued support from NINDS under the ACT for ALS initiative, which has enabled to expand access to MN‑166 while gathering meaningful clinical and biomarker insights. Together with our COMBAT‑ALS study, SEANOBI brings forward both clinical and real‑world evidence that will support discussions with regulators. We believe these combined data along with having Orphan Drug Designation from FDA and EMA and Fast Track Designation from FDA, will help us advance MN‑166 one step closer to becoming an approved treatment option for people living with ALS, who urgently need more choices.”
The NIH‑funded SEANOBI Expanded‑Access Program (EAP), supported by a $22 million NINDS grant under ACT for ALS, is designed to offer MN-166 (ibudilast) treatment access to individuals living with ALS who are not eligible to participate in ongoing randomized clinical trials. while also generating important biomarker and clinical outcome data from a real‑world ALS population.
MN‑166 (ibudilast) is also being evaluated in the COMBAT‑ALS Phase 2b/3 trial, a randomized, placebo‑controlled study assessing MN‑166’s efficacy and safety in ALS. The study includes a 12‑month double‑blind period followed by a 6‑month open‑label extension, with 234 patients enrolled in the U.S. and Canada. Top‑line results are expected by the end of 2026.
About SEANOBI-ALS
The SEANOBI Expanded‑Access Program (EAP) is a U.S.‑based initiative funded by a $22 million NINDS/NIH grant under ACT for ALS, designed to provide MN‑166 (ibudilast) to individuals living with ALS who are not eligible for ongoing randomized clinical trials. The program aims to enroll approximately 200 patients across 12 active sites and is structured to collect valuable real‑world clinical outcomes and biomarker data, including neurofilament levels.
About COMBAT‑ALS
COMBAT‑ALS is MediciNova’s ongoing Phase 2b/3 randomized, double‑blind, placebo‑controlled clinical trial evaluating the efficacy, safety, and tolerability of MN‑166 (ibudilast) in individuals with amyotrophic lateral sclerosis. A total of 234 patients have been randomized across clinical sites in the United States and Canada. The study includes a 12‑month double‑blind treatment period, followed by a 6‑month open‑label extension. Top‑line results are expected by the end of 2026. COMBAT‑ALS is designed to generate the controlled‑trial evidence necessary to support MN‑166’s potential future approval for the treatment of ALS.
References
https://www.ninds.nih.gov/news-events/directors-messages/all-directors-messages/updates-act-als
About MN-166 (ibudilast)
MN-166 (ibudilast) is an orally available small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). MediciNova holds Orphan Drug Designation for MN-166 (ibudilast) in ALS by U.S. FDA and EU EMA. MN-166 (ibudilast) has received Fast Track Designation by FDA for treatment of ALS. In addition, MN-166 (ibudilast) holds Orphan Disease Designation for the treatment of Glioblastoma.
About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
Investor Contact
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
[email protected]