MediciNova Announces Update and Basic Characteristic Randomized Patients' of Phase 2/3 Clinical Trial of MN-166 (Ibudilast) in ALS (COMBAT-ALS Clinical Trial) Presented at the 36th International Symposium on ALS/MND

Executive Summary

• MediciNova announced completion of enrollment for the COMBAT‑ALS Phase 2b/3 trial of MN‑166 (ibudilast), with 234 patients randomized.
• Baseline demographics and disease characteristics were disclosed, showing a patient population typical of ALS trials.
• The company expects top‑line efficacy data by the end of 2026 and highlighted ongoing orphan‑drug and fast‑track designations for MN‑166.

Key Details

• Trial Enrollment: 234 participants randomized; enrollment completed September 2025.
• Gender Distribution: Female 86 (36.8 %), Male 148 (63.2 %).
• Mean Age at Screening: 60.6 years.
• Racial Composition: Caucasian 90.2 %, Asian 5.1 %, African American 1.3 %, Native Hawaiian/Other Pacific Islander 0.4 %, American Indian/Alaskan Native 0.4 %, Other 2.6 %.
• ALS Onset Type: Upper limb 46.2 %, Lower limb 32.5 %, Bulbar 20.9 %, Unknown 0.4 %.
• Mean ALSFRS‑R Score at Screening: 40.6 (higher scores indicate better function).
• Mean Disease Duration from First Symptom: 12.5 months.
• Regulatory Status: MN‑166 holds Orphan Drug Designation and Fast Track Designation from the U.S. FDA, and Orphan Designation from the European Commission for ALS.
• Future Milestones: Top‑line efficacy data anticipated by end of 2026; continued support for patients via FDA’s Individual Patient Expanded Access Program.

Notable Quotes

“We anticipate top‑line data by the end of 2026 and remain hopeful that MN‑166 will represent a meaningful therapeutic advance for patients living with ALS.” – Dr. Yuichi Iwaki, President & CEO

“Achieving our randomization goal was not without challenges… we overcame these obstacles together.” – Dr. Kazuko Matsuda, Chief Medical Officer