Promising results of obefazimod in the treatment of ulcerative colitis

Abivax has announced significant results from its Phase 3 ABTECT maintenance trial, which is investigating obefazimod for moderate to severe active ulcerative colitis. The 25 mg and 50 mg doses significantly improved the clinical remission rate compared to placebo, reaching 50.8% and 51.3%, respectively, versus 10.4% for placebo.

Secondary endpoints, such as endoscopic improvement and the absence of corticosteroids, were also met. Obefazimod demonstrated a favorable tolerability profile, with no new safety signals. Abivax plans to submit an application for approval to the FDA in late 2026.