Abivax completed enrollment for its Phase 3 ABTECT trials of obefazimod, a treatment for moderately to severely active ulcerative colitis. The trials enrolled 1,275 participants, exceeding the target by 4%, and top-line results from the 8-week induction trials are expected in Q3 2025, followed by 44-week maintenance data in Q2 2026. If successful, a New Drug Application (NDA) submission is planned for the second half of 2026.
This successful enrollment signifies substantial progress in the development of a potential new treatment for ulcerative colitis. The large number of participants enrolled allows for a robust assessment of obefazimod’s efficacy and safety, potentially providing stronger evidence for regulatory approval. Furthermore, the rapid enrollment suggests strong interest in the trial from both clinicians and patients, highlighting the current unmet need for effective treatments in this area. This positive development could significantly enhance Abivax’s position within the inflammatory bowel disease market.
The baseline characteristics of the enrolled participants are consistent with those of the Phase 2b trial, suggesting a similar patient population and reinforcing confidence in the potential for comparable results. The company has confirmed that the current cash runway extends through the induction trials readout and into Q4 2025. The Data Safety Monitoring Board review conducted on April 25, 2025, did not reveal any new safety signals. Enrollment for the maintenance study is also progressing well, with 597 of the expected participants already enrolled, surpassing the minimum requirement for statistical power.
Positive Phase 3 trial results would represent a major step forward for Abivax, potentially leading to the approval of a new treatment option for ulcerative colitis. This could have a significant impact on the lives of patients suffering from this chronic inflammatory disease. The anticipated NDA submission in 2026 could pave the way for commercialization and establish obefazimod as a key player in the ulcerative colitis market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
