Abivax's Phase 3 Ulcerative Colitis Trial Nears Completion with 82% Enrollment
Key Insights
Abivax's ABTECT Phase 3 trial for obefazimod in ulcerative colitis (search) has reached 82% enrollment, with 1,003 of 1,224 participants now recruited.
Top-line results from the 8-week induction phase are expected in Q3 2025, while 44-week maintenance data is anticipated in Q2 2026.
A New Drug Application (NDA) submission is planned for the second half of 2026, contingent on positive clinical outcomes from the trial.
Abivax SA, a clinical-stage biotechnology company, has announced a significant milestone in its Phase 3 ABTECT clinical trial, which is evaluating obefazimod for the treatment of moderately to severely active ulcerative colitis (search) (UC). The trial has reached 82% of its target enrollment, with 1,003 out of 1,224 participants now recruited. This progress marks a crucial step toward addressing the unmet needs of patients suffering from this chronic inflammatory bowel disease.
The ABTECT trial is designed to assess the efficacy and safety of obefazimod, a potentially first-in-class oral treatment for UC. The company anticipates completing enrollment by Q2 2025. According to Marc de Garidel, CEO of Abivax, the trial's rapid enrollment underscores the enthusiasm of investigators and patients. He stated, "This progress underscores the enthusiasm of investigators and patients for this important trial, which remains among the fastest-enrolling Phase 3 UC trials to date."
Anticipated Data and Regulatory Milestones
Abivax expects to release top-line results from the 8-week induction phase of the ABTECT trial in Q3 2025. The 44-week maintenance data is projected to follow in Q2 2026. Assuming positive outcomes from these data readouts, the company plans to submit a New Drug Application (NDA) to regulatory authorities in the second half of 2026.
Consistent Patient Characteristics and Safety Profile
Blinded baseline characteristics of the enrolled participants align with the target population defined during the Phase 2b trial, ensuring consistency in the study population. Furthermore, the independent Data Monitoring Committee has not identified any new safety signals to date, reinforcing the favorable safety profile observed in earlier trials.
Financial Stability
Abivax CFO Didier Blondel affirmed the company's financial stability, stating, "Without the need for additional financing, our cash runway extends beyond the expected top-line results from the ABTECT induction trial and into Q4 2025, ensuring we remain well-positioned to execute our strategy." This financial security allows Abivax to focus on the successful execution of the ABTECT trial and the advancement of its broader portfolio of therapies for chronic inflammatory conditions.
Ulcerative Colitis: An Unmet Need
Ulcerative colitis (search) is a chronic inflammatory condition affecting the large intestine, characterized by inflammation and ulceration of the colon's innermost lining. Symptoms often include abdominal pain, diarrhea, rectal bleeding, and weight loss. Current treatments aim to reduce inflammation and relieve symptoms, but many patients do not achieve sustained remission, highlighting the need for new therapeutic options like obefazimod.