MediciNova Announces Completion of Patient Enrollment Evaluating MN-166 (ibudilast) in the Prevention of Chemotherapy-induced Peripheral Neuropathy
Rhea-AI Summary
MediciNova (NASDAQ:MNOV) announced completion of patient enrollment in the randomized, placebo-controlled Phase 2 OXTOX study evaluating MN-166 (ibudilast) to prevent chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer.
A total of 100 patients were randomized across two arms at 11 clinical sites in Australia. Patient recruitment is closed; participants continue chemotherapy with assigned study drug until disease progression or unacceptable toxicity. The study will conclude when the final patient reaches six months post-chemotherapy. Top-line data are anticipated later in 2026, though no exact completion date is provided.
Positive
- Enrollment complete: 100 patients randomized
- Study design: randomized, placebo-controlled Phase 2
- Multisite coverage: 11 clinical sites in Australia
- Clear primary timeline: study ends when final patient reaches 6 months post-chemotherapy
Negative
- No exact study completion date provided; only anticipated top-line later in 2026
- Results pending: clinical and investor impact depend on final 6-month post-chemo follow-up
Key Figures
Market Reality Check
Peers on Argus
Biotech peers showed mixed moves (e.g., APLT +2.74%, QNTM -5.8%), suggesting MNOV’s setup was more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 08 | ALS trial update | Positive | -3.2% | COMBAT-ALS Phase 2b/3 enrollment completion and baseline characteristics update. |
| Dec 01 | Pipeline & CEO message | Positive | -2.8% | MN-002 publication and Phase 2 MN-001-NATG-202 enrollment completion with 2026 data guide. |
| Nov 18 | Advisor appointment | Positive | +2.1% | Appointment of Dr. Breder as Clinical and Regulatory Advisor for development programs. |
| Nov 06 | Industry award | Positive | -7.3% | Biotech award recognizing MN-166 development and COMBAT-ALS trial progress. |
| Nov 04 | Enrollment completion | Positive | -5.3% | Completion of Phase 2 MN-001-NATG-202 enrollment in metabolic liver disease trial. |
Recent positive operational updates have often been followed by negative price reactions, indicating a pattern of selling into good news.
Over the last two months, MediciNova reported multiple clinical and corporate milestones, including completion of enrollment in the Phase 2 MN-001-NATG-202 trial and detailed baseline data for the COMBAT-ALS Phase 2b/3 study, both with top-line data expected by 2026. The company also highlighted a peer-reviewed MN-002 publication and appointed a new Clinical and Regulatory Advisor. Despite generally positive news flow, four of the last five events saw negative one-day price reactions, framing today’s enrollment update within a history of sell-the-news behavior.
Market Pulse Summary
This announcement marks completion of enrollment in the OXTOX Phase 2 trial of MN-166, with 100 metastatic colorectal cancer patients across 11 Australian sites, and top-line data anticipated in 2026. It adds to a string of recent enrollment milestones. From a balance-sheet perspective, MediciNova reported Q3 2025 cash of $32.56M, net loss of $3.05M, and access to a $30.0M SEPA plus a $75.0M ATM, so future updates on trial outcomes and financing use will be important to watch.
Key Terms
metastatic colorectal cancer medical
Phase 2 medical
AI-generated analysis. Not financial advice.
LA JOLLA, Calif., Dec. 18, 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), today announced the successful completion of patient enrollment in the randomized, placebo-controlled Phase 2 clinical trial, the OXTOX study (Oxaliplatin Neurotoxicity study in patients with metastatic colorectal cancer). This study, an investigator-initiated clinical trial led by Dr. Janette Vardy and Dr. Haryana Dhillon, is evaluating MN-166 (ibudilast) for the prevention of chemotherapy-induced peripheral neuropathy in patients with metastatic colorectal cancer. A total of 100 patients have been randomized across two treatment arms at 11 clinical sites in Australia. Patient recruitment is now officially closed.
Study participants will continue chemotherapy along with the assigned study drug (MN-166 or placebo) until disease progression or unacceptable side effects. The study will conclude when the final patient reaches six months post-chemotherapy. While the exact study completion date is not yet determined, we anticipate that top-line data may be available later in 2026.
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). For the ALS indication, MediciNova has Orphan Drug Designation& Fast Track Status from the US FDA and Orphan Drug Designation from the EMA.
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-001 (tipelukast) is in a Phase 2 trial treating hypertriglyceridemia in type 2 diabetic patients. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
Forward-Looking Statements
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
FAQ
What did MediciNova (MNOV) announce on December 18, 2025 about MN-166?
How many patients and sites are in the MN-166 OXTOX study (MNOV)?
When will MediciNova (MNOV) report top-line results from the OXTOX study?
What is the OXTOX study endpoint timing for MN-166 (MNOV)?
Will patients continue chemotherapy during the MN-166 (MNOV) trial?
