Abivax Announces Positive Phase 3 Results for Obefazimod in Ulcerative Colitis

Abivax has released positive results from the ABTECT Maintenance Part 2 trial, bolstering the safety and efficacy profile of obefazimod for refractory ulcerative colitis. The trial demonstrated that 37.2% of induction non-responders achieved clinical remission, and 34.5% reached endoscopic remission by Week 44 under a 50 mg treatment regimen. This dose escalation also recaptured clinical remission in 45.5% of patients who experienced a relapse during the Part 1 trial, signaling a viable strategy for sustainable disease control.

Across an integrated Phase 2 and 3 program involving 1,704 patient-years, incidences of malignancies and non-melanoma skin cancer remained consistent with expected background rates, supporting the treatment's long-term safety. The findings contribute to a robust data set intended for a New Drug Application submission aimed at addressing unmet needs in ulcerative colitis treatment.