MediciNova Announces 100 Patients Enrolled in SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN?166 (ibudilast) in ALS patients
MWN-AI** Summary
MediciNova, Inc., a biopharmaceutical company listed on NASDAQ (MNOV) and the Tokyo Stock Exchange (4875), announced significant progress in its SEANOBI Expanded Access Program (EAP), with 100 patients enrolled out of a targeted 200. This study (NCT 06743776) evaluates the efficacy of MN-166 (ibudilast) in treating amyotrophic lateral sclerosis (ALS) and is supported by the National Institute of Neurological Disorders and Stroke (NINDS) through a $22 million grant under the ACT for ALS initiative.
Dr. Yuichi Iwaki, MediciNova's CEO, expressed gratitude to the patients and their families for their participation, emphasizing that their involvement is critical for advancing the clinical development of MN-166. The SEANOBI study is notable not only for its patient enrollment but also for its focus on gathering real-world clinical and biomarker data, particularly neurofilament levels, to aid regulatory discussions.
In tandem, MediciNova is conducting the COMBAT-ALS Phase 2b/3 trial, a randomized, placebo-controlled study assessing MN-166's safety and efficacy in ALS patients. Preliminary results from the COMBAT-ALS trial are expected by the end of 2026, reinforcing the company's commitment to generating robust evidence for regulatory approval.
MN-166 is an orally available small molecule that inhibits specific inflammatory pathways and is being studied for various neurodegenerative diseases. It holds Orphan Drug Designation from the FDA and EMA and Fast Track Designation from the FDA for ALS treatment.
This dual approach, combining SEANOBI and COMBAT-ALS, could provide compelling clinical and real-world evidence that may enhance the prospect of MN-166 becoming a viable therapeutic option for ALS patients facing urgent treatment needs.
MWN-AI** Analysis
MediciNova's recent announcement regarding the enrollment of 100 patients in the SEANOBI Expanded-Access Program (EAP) evaluating MN-166 (ibudilast) for treating amyotrophic lateral sclerosis (ALS) signals significant progress in the company's clinical development efforts. As it stands, half of the targeted enrollment for this NIH-funded study has been achieved, and the involvement of 12 active sites across the U.S. enhances the program's credibility and reach.
From a market perspective, the advancement of the SEANOBI study, alongside the concurrent COMBAT-ALS trial, presents a compelling narrative for investors interested in biopharmaceutical stocks, particularly those focusing on neurodegenerative disorders. With MediciNova having secured Orphan Drug Designation and Fast Track Designation from the FDA, there's an enhanced chance for regulatory success, which could drive the stock price up as the timeline progresses toward the expected top-line results in late 2026.
Investors should consider the momentum built by these designations, which not only emphasize the unmet need in ALS treatment but also provide a strategic advantage for MediciNova regarding potential approval pathways. The company's strong ties to NIH funding further establish its credibility in the space and could catalyze additional interest from institutional investors.
Nevertheless, potential investors should remain cautious of inherent risks related to clinical trials, including the unpredictability of results and the financial requirements tied to ongoing development. The success of MN-166 is contingent upon favorable outcomes from both the SEANOBI and COMBAT-ALS trials, making thorough research and ongoing monitoring of clinical progress crucial. Overall, MediciNova presents an intriguing opportunity in the biopharmaceutical arena, especially as clinical data becomes available in the next year.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
LA JOLLA, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- 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.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
INVESTOR CONTACT:
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com
FAQ**
How is MediciNova Inc. MNOV's progress in the SEANOBI study expected to influence investor confidence and interest in its stock as it aims to enroll the full 200 patients?
What are the anticipated impacts of the SEANOBI Expanded Access Program on MediciNova Inc. MNOV's market position and potential partnerships within the biopharmaceutical industry?
Given the potential FDA approval implications, how might the results from the COMBAT-ALS trial affect the market valuation of MediciNova Inc. MNOV in late 2026?
How does MediciNova Inc. MNOV plan to utilize the real-world data collected from the SEANOBI study to strengthen its position in the competitive ALS treatment market?
**MWN-AI FAQ is based on asking OpenAI questions about MediciNova Inc. (NASDAQ: MNOV).
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