MediciNova Achieves Enrollment in COMBAT-ALS Clinical Trial

Rhea-AI Summary

MediciNova (NASDAQ:MNOV) has announced the successful completion of target enrollment in its Phase 2b/3 COMBAT-ALS clinical trial for MN-166 (ibudilast), a drug candidate being developed for Amyotrophic Lateral Sclerosis (ALS) treatment.

The multi-site trial, conducted across the United States and Canada, represents a crucial milestone in MN-166's development program. According to CEO Dr. Yuichi Iwaki, this achievement reflects strong collaboration between clinical sites, investigators, and patient communities, bringing the company closer to evaluating MN-166's potential impact on ALS patients.

Positive

• Successfully achieved target enrollment for Phase 2b/3 COMBAT-ALS trial
• Study conducted across multiple sites in US and Canada, indicating broad reach
• Development progressing for potential treatment of major disease with high unmet need

Negative

• No efficacy or safety data reported yet
• Timeline for trial completion and data readout not specified

LA JOLLA, Calif., Aug. 26, 2025 (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), announces that it successfully achieved enrollment of the target number of participants in its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast). MN-166 is currently in development for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Dr. Yuichi Iwaki, MediciNova President and CEO commented, “This milestone marks a significant step forward in the development of MN-166, reflecting strong collaboration among clinical sites, investigators, and patient communities. We are grateful to all the patients, their family, caregivers, investigators, and study teams whose dedication made this achievement possible. Reaching our target number enrollment allows us to move confidently into the next phase of the trial and brings us closer to understanding the potential impact of MN-166 and potentially bring hope to the millions of people who suffer from this devastating condition.”

The Phase 2b/3 COMBAT-ALS study has enrolled participants across multiple sites in US and Canada.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a 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).   

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 2b/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

What milestone did MediciNova (MNOV) announce for its COMBAT-ALS trial?

MediciNova announced reaching its target enrollment for the Phase 2b/3 COMBAT-ALS clinical trial of MN-166 (ibudilast) for ALS treatment.

What is the purpose of MediciNova's COMBAT-ALS clinical trial?

The COMBAT-ALS trial is studying MN-166 (ibudilast) as a potential treatment for Amyotrophic Lateral Sclerosis (ALS), a devastating neurological condition.

Where is MediciNova conducting its COMBAT-ALS clinical trial?

The Phase 2b/3 COMBAT-ALS study is being conducted across multiple sites in the United States and Canada.

What phase is MediciNova's COMBAT-ALS trial currently in?

The COMBAT-ALS trial is a Phase 2b/3 clinical trial, which is an advanced stage of clinical development.

What is MN-166, and what is it being developed for?

MN-166 (ibudilast) is MediciNova's drug candidate being developed as a potential treatment for Amyotrophic Lateral Sclerosis (ALS).