Abivax Completes Enrollment For Phase 3 ABTECT Trials In Ulcerative Colitis

Abivax is a clinical-stage biotechnology organization dedicated to creating treatments that employ the body's built-in regulatory systems to help patients with long-term inflammatory conditions calm their immune responses. The company has announced the successful completion of  enrollment for its pivotal Phase 3 ABTECT clinical trials, which evaluate its investigational treatment for moderately to severely active ulcerative colitis. A total of 1,275 participants have been enrolled across two induction studies, with 597 already entered into Part 1 of the 44-week maintenance trial surpassing the minimum needed for statistical robustness.

Marc de Garidel, Chief Executive Officer of Abivax, commented, “Completing enrollment for our Phase 3 ABTECT trials one of the largest and fastest enrolling ulcerative colitis programs of its kind ever conducted is a landmark achievement for both Abivax and the UC patient community. Obefazimod has already shown compelling potential to address the significant unmet needs of patients with moderately to severely active disease. We remain fully committed to advancing this pivotal program: we expect to report top‑line induction results in Q3 2025, followed by comprehensive long‑term maintenance data in Q2 2026. Should these data confirm obefazimod’s safety and efficacy, we plan to submit a New Drug Application to the FDA in the second half of 2026, bringing us ever closer to delivering a desperately needed new therapeutic option.”

ABTECT has successfully completed enrollment of 1,275 participants across two Phase 3 pivotal studies. In the ongoing 44-week maintenance study, 597 of the 1,111 eligible participants have enrolled in Part 1 ('responder arm'), surpassing the minimum required for statistical power, with enrollment continuing through June 2025. Top-line data from the induction trials is expected in Q3 2025, and maintenance results in Q2 2026. Blinded baseline data confirms alignment with the target population from the Phase 2b UC study. The most recent DSMB review (April 25, 2025) reported no new safety signals. Pending positive results, the company plans to proceed with its regulatory strategy.

Fabio Cataldi, MD, Chief Medical Officer of Abivax added, "Importantly, the blinded baseline characteristics of participants in the Phase 3 ABTECT trials closely align with those observed in our Phase 2b trial. This consistency reinforces our confidence in obefazimod’s potential efficacy and safety profile as we advance through the pivotal stage of its clinical development."

Assuming positive trial outcomes, Abivax plans to submit a New Drug Application (NDA) to the U.S. FDA in the second half of 2026. This marks a major milestone for the company as it advances a potential new treatment option for chronic inflammatory bowel diseases.