Abivax Anticipates Phase 3 Trial Results by End of June 2026
Biotechnology company Abivax has outlined its outlook for 2026, focusing on the anticipated results of its phase 3 ABTECT-UC maintenance trial evaluating obefazimod in ulcerative colitis. According to the company, no new safety signals were identified during the latest meeting of the independent monitoring committee.
Phase 3 Maintenance Trial Results Expected by Q2 2026
Abivax reports that initial results from the phase 3 ABTECT-UC maintenance trial are expected by the end of the second quarter of 2026. The Data Safety Monitoring Board (DSMB) meeting, which took place on December 18, 2025, identified no new safety signals, while over 80% of participants have completed the 44-week double-blind maintenance trial. The company plans to submit a New Drug Application (NDA) in the United States by the end of 2026, following planned discussions with the FDA. The trial assesses obefazimod, an oral drug candidate, in the treatment of moderately to severely active ulcerative colitis (UC).
Global Sales in Ulcerative Colitis Expected to More Than Double
According to several industry analyses cited by Abivax, global sales in ulcerative colitis are expected to more than double, rising from $9.2 billion in 2025 to $21.2 billion by 2032. A market study conducted following the announcement of the phase 3 ABTECT induction trial results in July 2025 estimates that obefazimod could emerge as a future market leader in UC. The study indicates that approximately 500,000 patients in the United States currently receive conventional treatments, and nearly 60% of them have a moderate to severe form of the disease, equating to about 300,000 patients. According to the release, physicians surveyed indicated they would likely initiate treatment with obefazimod for this population.
Ongoing Phase 2b Induction Trial in Crohn's Disease
The phase 2b ENHANCE-CD induction trial, evaluating obefazimod in moderately to severely active Crohn's disease, is ongoing. Results from the 12-week induction trial are expected by the end of 2026, according to the company. Abivax reports that 22 abstracts have been accepted for the upcoming European Crohn's and Colitis Organization (ECCO) congress in February 2026, including an oral presentation on the effect of obefazimod on fibrosis in in vitro and preclinical models. The company notes that it continues to evaluate obefazimod in combination with other agents, and a priority candidate for a combination will be selected by the end of the year. Abivax also indicates that it has financial visibility until the fourth quarter of 2027, following full repayment of its debt in the fourth quarter of 2025.
