Clinical TrialJun 29, 2026, 05:27 PM
Abivax's Obefazimod Shows Positive Phase 3 UC Maintenance Results
AI Summary
Abivax reported positive topline results from ABTECT Maintenance Part 2 for obefazimod in moderately to severely active ulcerative colitis. The study demonstrated meaningful clinical benefit in highly refractory patients, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission with 50 mg treatment. The expanded safety data further strengthened confidence in obefazimod's long-term safety profile, with malignancy rates consistent with expected ulcerative colitis background rates. The company remains on track for a New Drug Application submission in Q4 2026.
Key Highlights
- Obefazimod 50 mg achieved 37.2% clinical remission and 34.5% endoscopic remission in induction non-responders at Week 44.
- Dose escalation to 50 mg recaptured clinical remission in 45.5% of patients who relapsed during Maintenance Part 1.
- Integrated Phase 2/3 program showed EAIRs for malignancies (excl. NMSC) of 0.35 per 100 PYs (all-active combined).
- Integrated Phase 2/3 program showed EAIRs for NMSC of 0.59 per 100 PYs (all-active combined).
- All malignancy rates were consistent with expected UC background rates.
- Abivax plans to submit its NDA for obefazimod in UC in Q4 2026.
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