Abivax Obefazimod Yields 37% UC Remission, Strengthens Phase 3 Safety Database
ABVX•Abivax reported that 37.2% of induction non-responders achieved clinical remission at Week 44 and 34.5% endoscopic remission after continued 50 mg obefazimod, while dose escalation recaptured remission in 45.5% of relapsing patients. Integrated safety data show EAIRs for malignancies at 0.69 per 100 patient-years, supporting a robust long-term safety database.
1. Positive Maintenance Part 2 Results
In ABTECT Maintenance Part 2, adults with moderately to severely active ulcerative colitis who failed induction achieved meaningful benefit after continued obefazimod treatment: clinical remission of 37.2%, clinical response of 61.5%, endoscopic improvement of 48.0%, HEMI of 44.6% and endoscopic remission of 34.5% at Week 44 on 50 mg.
2. Dose Escalation Efficacy
Patients who relapsed during Part 1 maintenance regained disease control with dose escalation to 50 mg obefazimod: those switched from placebo achieved 69.7% clinical response and 45.0% remission, while 25 mg-to-50 mg escalators reached 66.7% response and 45.5% remission by Week 44, demonstrating a practical strategy for sustained control.
3. Integrated Safety Database
Across the integrated Phase 2 and Phase 3 UC program (1,704 patient-years), EAIRs for malignancies excluding NMSC were 0.48 and 0.69 per 100 patient-years in the combined and 50 mg cohorts, respectively, and NMSC rates were 0.95 and 0.69 per 100 patient-years. All events occurred in patients with established risk factors, aligning with ulcerative colitis background rates.
4. Next Steps and Regulatory Plans
Abivax will discuss these results on a conference call and webcast today, with a planned NDA submission later this year. The expanded efficacy and safety dataset underpins the company’s preparation for regulatory filing and positions obefazimod as a potential paradigm-shifting treatment for patients with refractory ulcerative colitis.
