MediciNova, Inc. has finished enrolling patients in its investigator‑initiated Phase 2 OXTOX study, a trial that evaluates the small‑molecule drug MN‑166 (ibudilast) for preventing chemotherapy‑induced peripheral neuropathy (CIPN) in patients with metastatic colorectal cancer. The study enrolled 100 patients across 11 clinical sites in Australia and is now officially closed to enrollment.
The trial design keeps patients on their assigned treatment—MN‑166 or placebo—alongside standard chemotherapy until disease progression or unacceptable side effects. The study will conclude when the last patient reaches six months after completing chemotherapy, with top‑line data expected in late 2026. Completion of enrollment marks a key milestone for MediciNova’s CIPN program, expanding the therapeutic potential of MN‑166 beyond its ALS and multiple‑sclerosis indications.
MediciNova’s financial position remains a concern. In the third quarter of 2025 the company reported a net loss of $3.05 million on revenue of $0.12 million, and cumulative revenue for the first three quarters of 2025 was $0.26 million against a net loss of $9.20 million. The company has no debt and relies on a standby equity purchase agreement and an at‑the‑market program to fund ongoing clinical development.
The OXTOX study is significant because CIPN is a common and debilitating side effect of many chemotherapies, and no single therapy currently provides adequate protection. Ibudilast’s mechanism—non‑selective phosphodiesterase inhibition and anti‑inflammatory activity—has shown neuroprotective effects in preclinical models and in early‑stage trials for ALS and multiple sclerosis. Successful results in OXTOX could open a new market for a drug that has already demonstrated tolerability in multiple neurological indications.
MediciNova’s broader pipeline includes MN‑166 in Phase 3 trials for ALS and progressive multiple sclerosis, and MN‑001 (tipelukast) for fibrotic and metabolic disorders. The company’s Orphan Drug Designation and Fast Track status for MN‑166 in ALS, along with its EMA orphan designation, underscore the potential for accelerated regulatory pathways if the drug proves effective in CIPN.
The completion of enrollment provides a clear path to data that could validate MN‑166’s efficacy in a large, unmet‑need patient population. Positive top‑line results would strengthen the company’s case for expanding the drug’s indications and could justify additional investment in the pipeline, while negative results would prompt a reassessment of the drug’s development strategy.
The company’s financial resilience will be tested as it continues to fund clinical trials. The reliance on equity financing and the absence of debt highlight the importance of future funding rounds or partnerships to sustain development momentum.
Overall, the enrollment milestone is a positive operational development that could enhance MediciNova’s therapeutic portfolio, but the company’s fragile financial footing remains a key risk factor for investors.
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