Clinical TrialJun 2, 2026, 06:12 AM
Abivax Obefazimod Phase 3 Trial Meets Primary Endpoint for Ulcerative Colitis
AI Summary
Abivax announced positive topline results from its Phase 3 ABTECT maintenance trial for obefazimod in ulcerative colitis. Both 25mg and 50mg doses met the primary endpoint of clinical remission at Week 44, showing significant placebo-adjusted rates. All key secondary endpoints were also met, and the drug demonstrated a favorable safety profile with no new signals. Abivax plans to submit an NDA to the FDA in late Q4 2026 and expects Crohn's disease trial results in mid-2027.
Key Highlights
- Abivax's Phase 3 ABTECT maintenance trial shows obefazimod achieved primary endpoint with placebo-adjusted clinical remission rates of 39.3% (25mg) and 40.3% (50mg) at Week 44.
- Both 25mg and 50mg obefazimod doses met all key secondary endpoints, demonstrating robust efficacy in ulcerative colitis.
- Obefazimod maintained a favorable safety profile over 44 weeks with no new safety signals identified.
- The company plans to submit a New Drug Application (NDA) to the FDA for obefazimod in ulcerative colitis in late Q4 2026.
- Phase 2b induction trial for Crohn's disease topline results are expected mid-year 2027.
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