Abivax Announces Phase 3 Trial Results for Ulcerative Colitis Treatment

Abivax has reported promising results from its Phase 3 ABTECT maintenance trial, evaluating obefazimod for moderately to severely active ulcerative colitis. The study included doses of 25 mg and 50 mg, both of which reached the primary endpoint with clinical remission rates of 50.8% and 51.3%, respectively, versus 10.4% for placebo (p<0.0001).

The trial, which lasted 44 weeks, also saw obefazimod meet all key secondary endpoints, showcasing significant efficacy across multiple disease control measures. The safety profile of obefazimod was favorable, with no new safety signals observed among 580 participants.

Abivax is planning to submit a New Drug Application to the FDA by Q4 2026. Future milestones include the Phase 2b induction trial results for Crohn’s disease expected mid-2027.