MediciNova Announces Completion of Patient Enrollment Evaluating MN-166 (ibudilast) in the Prevention of Chemotherapy-induced Peripheral Neuropathy

Executive Summary

• MediciNova announced that patient enrollment for the randomized, placebo‑controlled Phase 2 OXTOX study (MN‑166/ibudilast) is now closed, with 100 patients enrolled across 11 Australian sites.
• The trial will continue treatment until disease progression or unacceptable toxicity, with final data expected after the last patient reaches six months post‑chemotherapy, anticipated in late 2026.
• Completion of enrollment removes a major execution risk and positions MediciNova to generate top‑line efficacy and safety data that could support further development of MN‑166 for chemotherapy‑induced peripheral neuropathy (CIPN).

Key Details

• Study Design: Randomized, double‑blind, placebo‑controlled Phase 2 trial evaluating MN‑166 (ibudilast) versus placebo for prevention of oxaliplatin‑induced peripheral neuropathy in metastatic colorectal cancer patients.
• Enrollment: 100 patients fully randomized; enrollment closed across 11 clinical sites in Australia.
• Treatment Duration: Patients receive study drug (MN‑166 or placebo) concurrently with standard chemotherapy until disease progression or unacceptable side effects.
• Data Timeline: Study will conclude when the last patient completes six months post‑chemotherapy; top‑line results expected later in 2026.
• Investigators: Led by Dr. Janette Vardy and Dr. Haryana Dhillon (investigator‑initiated trial).
• Implications for MN‑166 Pipeline: Adds a new indication (CIPN) to the existing late‑stage portfolio, which already includes Phase 3 ALS and DCM programs and Phase 3‑ready progressive MS program.

Notable Quotes

(No direct quotes were provided in the release.)