Biopharmaceutical company MediciNova Inc. (MNOV:NASDAQ) announced that by the end of January 2026, 12 sites in the U.S. have been activated and 100 patients have been enrolled in the SEANOBI study (Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS), according to a January 29 release.
This represents 50% of the planned 200 participants, evaluating MN 166 (ibudilast) in patients with amyotrophic lateral sclerosis (ALS), the company said.
"Achieving 100 enrolled patients in the NIH funded SEANOBI Expanded Access Program marks substantial progress in the clinical development of MN 166," President and Chief Executive Officer Dr. Yuichi Iwaki said. "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."
Iwaki continued, "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 SEANOBI Expanded Access Program (EAP), funded by a US$22 million NINDS grant under ACT for ALS, is designed to provide ibudilast treatment to individuals with ALS who are not eligible for ongoing randomized clinical trials, while also generating important biomarker and clinical outcome data from a real-world ALS population.
Ibudilast is also being evaluated in the COMBAT ALS Phase 2b/3 trial, a randomized, placebo-controlled study assessing its efficacy and safety in ALS. The study includes a 12-month double-blind period followed by a six-month open-label extension, with 234 patients enrolled in the U.S. and Canada. Top-line results are expected by the end of 2026.
The SEANOBI 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.
Generating Evidence for Future Approval of ALS Treatment
COMBAT ALS is MediciNova’s ongoing Phase 2b/3 randomized, double-blind, placebo-controlled clinical trial assessing the efficacy, safety, and tolerability of ibudilast in individuals with ALS. 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 six-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.
The company stated that 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, 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.
Additionally, ibudilast was evaluated in patients at risk for developing acute respiratory distress syndrome (ARDS). MediciNova holds Orphan Drug Designation for ibudilast in ALS by U.S. FDA and EU EMA, and ibudilast has received Fast Track Designation by FDA for treatment of ALS. Furthermore, ibudilast holds Orphan Disease Designation for the treatment of Glioblastoma.
Analyst: Update Highlights Ongoing Clinical Progress
According to an updated research note written by Jason Kolbert for D. Boral Capital on January 30, the company's update highlights ongoing clinical progress supported by the grant under the ACT for ALS initiative, expanding real-world exposure of MN-166 while generating biomarker and outcomes data outside traditional randomized trials. The announcement underscores management's strategy of combining controlled clinical evidence with expanded access data to bolster future regulatory discussions.
With 12 active U.S. sites and enrollment proceeding as planned, the program offers both patient access and an additional data stream that may help mitigate development risks, particularly in biomarker validation and safety profiling, Kolbert noted. While expanded access data is not typically registrational, its value lies in supporting signal consistency and demonstrating broader tolerability across diverse populations.
Parallel development through the COMBAT ALS Phase 2b/3 randomized trial remains the primary driver of efficacy, with 234 patients enrolled across the U.S. and Canada, and topline data expected by the end of 2026, he said.
"The dual-track approach of controlled and real-world data, combined with existing Orphan Drug and Fast Track designations, maintains regulatory optionality while enhancing visibility into MN-166’s risk-benefit profile," the analyst wrote.
Investors should focus on continued SEANOBI enrollment progress and potential interim biomarker disclosures at 2026 scientific meetings, Kolbert said. Key milestones include anticipated top-line data from the COMBAT ALS study by the end of 2026, which remains the central valuation inflection point, as well as expected top-line results from the OXTOX CIPN study later in 2026.
Ongoing advancement of Phase 3 programs in ALS and degenerative cervical myelopathy, and possible regulatory or clinical updates supporting Phase 3 initiation in progressive multiple sclerosis, are also important, he said. Additional investigator-sponsored study readouts or incremental funding announcements could further enhance the clinical and strategic value of the ibudilast franchise.
For D. Boral's model, Kolbert said the firm valued MN-166 in ALS, applying a probability of success factor of 30% based on its pivotal trial status.
Kolbert rated the stock a Buy.
"We assume additional capital will be raised in our final share count," Kolbert wrote. "We then apply these projections to our Free Cash Flow to the firm, or FCFF, discounted EPS or dEPS, and sum-of-the-parts or SOP models, which are equal-weighted, averaged, and rounded to the nearest whole number to derive our 12-month price target of US$9."
The Catalyst: Geriatric Population Growing
Approximately 30,000–33,000 individuals in the U.S. are living with ALS, with around 5,000 new cases diagnosed each year, according to the American Medical Association.
ALS is a progressive neurodegenerative disease most prevalent in people aged 55–75, with an average survival of 2–5 years post-diagnosis. The condition is 20% more common in men and is predominantly sporadic.
According to Target ALS, the disease is diagnosed in about 1.7 to 2.2 out of every 100,000 people annually, making it a rare illness in the broader context of health conditions. Although rare, its impact on those affected and their families is profound.
The global market for amyotrophic lateral sclerosis (ALS) treatment was valued at US$667.3 million in 2023 and is projected to grow to US$987.6 million by 2030, with a compound annual growth rate (CAGR) of 5.8% from 2024 to 2030, Grand View Research reported.
Streetwise Ownership Overview*A significant factor driving this market expansion is the increasing incidence and prevalence of ALS, particularly sporadic ALS, which accounts for 90%-95% of cases.
"Furthermore, the growing geriatric population, a key risk factor for ALS, is also contributing to the rise in cases. As the population ages, the demand for effective treatment options is likely to increase," the research firm noted.
Ownership and Share Structure1
About 3% of MediciNova is owned by insiders and management, and about 22% is owned by institutions. The rest is retail.
Top investors include 3D Investment Partners Pte. Ltd. with 11.2%; EW Healthcare Partners with 2.25%; President, Chief Executive Officer, and founder Yuichi Iwaki with 2.22%; BlackRock Institutional Trust Co. with 1.4%; and The Vanguard Group Inc. with 1.44%.
It has 49.15 million shares outstanding with a US$86.01 million market cap. It trades in a 52-week range of US$1.13 and US$2.06.
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1. Ownership and Share Structure Information
The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.
