Abivax Obefazimod Phase 3 Part 2 shows clinical benefit in UC
Abivax announced positive topline results from ABTECT Maintenance Part 2 for obefazimod in moderately to severely active ulcerative colitis (UC). The study demonstrated meaningful clinical benefit in highly refractory UC patients, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 with 50 mg treatment. The results also showed that dose escalation to 50 mg recaptured clinical remission in 45.5% of patients who relapsed. The expanded safety data further strengthened confidence in obefazimod's long-term safety profile, with malignancy rates consistent with expected UC background rates. The company remains on track for an NDA submission in Q4 2026.
Key Highlights
- Obefazimod 50 mg achieved 37.2% clinical remission in induction non-responders at Week 44.
- Obefazimod 50 mg achieved 34.5% endoscopic remission in induction non-responders at Week 44.
- Dose escalation to 50 mg recaptured clinical remission in 45.5% of relapsed patients.
- Malignancy EAIRs (excluding NMSC) were 0.35-0.64 per 100 PYs, consistent with UC background rates.
- NMSC EAIRs were 0.59-0.64 per 100 PYs, consistent with UC background rates.
- NDA submission for obefazimod in UC is planned for Q4 2026.
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