Full Press Release Details
LA JOLLA, Calif., July 15, 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 the target enrollment of 200 patients has been achieved in the SEANOBI-ALS study (Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS ; NCT 06743776) evaluating MN‑166 (ibudilast) in patients with amyotrophic lateral sclerosis (ALS).
The Expanded Access Program SEANOBI study is funded by National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health (NIH) supported under the ACT for ALS. This program is designed to provide MN‑166 (ibudilast) to individuals living with ALS who are not eligible to participate in ongoing randomized clinical trials. Reaching this enrollment milestone reflects the strong engagement of the ALS community and the dedicated efforts of patients, families, investigators, and clinical staff involved in the program.
Active participants in the SEANOBI-ALS study remain on-track with treatment and protocol-specified follow-ups. Final patient follow-ups are projected to conclude in early 2027, triggering the data analysis phase to support upcoming scientific presentations and peer-reviewed publications by an academic lead investigator.
MN‑166 (ibudilast) is an orally available small‑molecule inhibitor of phosphodiesterase‑4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). The compound is currently being evaluated across multiple neuroinflammatory and neurodegenerative indications, including ALS. MediciNova announced in September 2025 that it successfully completed enrollment of the target number of participants in its COMBAT-ALS Phase 2b/3 clinical trial of MN-166.
Dr. Yuichi Iwaki, President and CEO of MediciNova, commented: “Achieving full enrollment of 200 patients in this NIH‑funded SEANOBI-ALS study marks an extraordinary milestone for the ALS community. We are deeply grateful to the patients and families who have chosen to participate, as well as to the NIH for its vital support through the ACT for ALS. Their partnership has successfully enabled access to the investigational drug MN‑166 (ibudilast) for individuals who otherwise lacked clinical trial options, and we remain entirely focused on executing the remaining protocol steps with the utmost urgency and care.”
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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 numerous 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, 2025 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.