Abivax Targets End of 2026 for Regulatory Filing of Ulcerative Colitis Treatment
Biotechnology company Abivax has outlined its priorities for 2026, focusing on completing its Phase 3 maintenance trial for obefazimod in treating ulcerative colitis. The company plans to submit a marketing authorization application in the United States by the end of the year, according to a statement released on January 7.
Completion of Phase 3 Maintenance Trial
Complete results from the ABTECT Phase 3 maintenance trial are expected by the end of the second quarter of 2026, the company states. At a Data Safety Monitoring Board (DSMB) meeting held on December 18, 2025, no new safety signals were identified, with over 80% of participants completing the 44-week double-blind maintenance phase. The company is currently preparing its New Drug Application (NDA) dossier and anticipates discussions with the FDA with a view to filing by the end of 2026. Obezafimod had shown positive data during the 8-week induction trial in July 2025, according to the statement.
Significant Market Growth Anticipated
Several third-party industry analyses predict significant growth in the ulcerative colitis market in the coming years, reports Abivax. A recently published report estimates that global sales are expected to more than double, from $9.2 billion in 2025 to $21.2 billion by 2032. A market study conducted after the announcement of the Phase 3 induction results in July 2025 suggests that obefazimod could emerge as a market leader in ulcerative colitis, according to the group. This research estimates that about 500,000 patients in the United States are currently on conventional therapies, with approximately 60% having moderate to severe forms, which is about 300,000 patients.
Progress in ENHANCE-CD Phase 2b Trial
The Phase 2b ENHANCE-CD trial, designed to assess the efficacy of obefazimod in patients with moderate to severe Crohn's disease, is actively progressing. Results from the 12-week induction trial are anticipated by the end of 2026 and will guide the design of future registration studies, the company indicates. Abivax also plans to share in 2026 the initial preclinical results of studies evaluating obefazimod in combination with other agents, including IL-23, a4b7, PDE-4, and AhR. A principal combined candidate is expected to be selected for advanced development by the end of the year. Additionally, 22 detailed abstracts will be presented at the annual ECCO congress to be held in Stockholm from February 18 to 21, 2026. The recently obtained funding is expected to support the company's operations until the fourth quarter of 2027, according to the statement.
