A NIH-funded expanded-access program, SEANOBI, backed by a $22 million NINDS grant under ACT for ALS, aims to provide MN-166 (ibudilast) to ALS patients ineligible for randomized trials while collecting real-world clinical and biomarker data, including neurofilament levels.

MN-166 is an orally available PDE4 inhibitor with anti-inflammatory effects, under development for ALS and multiple other conditions, and carries several regulatory designations.

MediciNova reports that 100 patients have been enrolled in SEANOBI across 12 U.S. sites, hitting half of the planned 200 enrollment.

Risks cited include ongoing recruitment challenges, reliance on NIH funding, and uncertainties typical of clinical development and trial financing.

MediciNova’s CEO describes the SEANOBI milestone as meaningful progress in MN-166’s clinical development and NIH/NINDS collaboration.

MediciNova emphasizes that continued NIH support under ACT for ALS is critical to expanding access to MN-166 and advancing the company’s development program.

SEANOBI runs in parallel with the COMBAT-ALS Phase 2b/3 trial, which plans to enroll 234 patients in the U.S. and Canada and aims to release top-line results by year-end 2026.

COMBAT-ALS features a 12-month double-blind period followed by a 6‑month open-label extension, with results expected at the end of 2026.

Top-line results for COMBAT-ALS are anticipated by the end of 2026, with Mayo Clinic-related references noted in the context of ongoing ALS research collaborations.