MediciNova, Inc. recently 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 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 (CIPN) 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, top-line data are anticipated later in 2026.

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, and substance use disorder. In addition, MN-166 has been evaluated in patients 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.

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, is currently in Phase 3 for ALS and DCM and is Phase 3-ready for progressive MS. MN-001 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.