Clinical TrialJun 1, 2026, 04:05 PM
Abivax Obefazimod Phase 3 UC trial meets primary endpoint
AI Summary
Abivax announced positive topline results from its Phase 3 ABTECT maintenance trial for obefazimod in moderately to severely active ulcerative colitis. Both the 25 mg and 50 mg once-daily doses met the primary endpoint of clinical remission at Week 44, demonstrating placebo-adjusted rates of ∆39.3% and ∆40.3% respectively. The trial also met all key secondary endpoints and showed a favorable safety profile with no new signals. The company plans to submit a New Drug Application to the FDA for obefazimod in ulcerative colitis in late Q4 2026, with Phase 2b Crohn's disease trial results expected mid-2027.
Key Highlights
- Obefazimod 25 mg achieved 50.8% clinical remission at Week 44 (∆39.3% vs placebo).
- Obefazimod 50 mg achieved 51.3% clinical remission at Week 44 (∆40.3% vs placebo).
- Both obefazimod doses met all key secondary endpoints, demonstrating robust efficacy.
- Obefazimod showed a favorable safety profile over the 44-week maintenance trial.
- Abivax plans to submit a New Drug Application to the FDA for obefazimod in UC in late Q4 2026.
- Phase 2b induction trial topline results for Crohn’s disease are expected mid-2027.
- Phase 2a/2b open-label extension data showed durable clinical remission up to seven years.
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