Abivax announces completion of enrollment for the phase III ABTECT trials in patients with moderately to severely active ulcerative colitis

 Abivax SA  announced the completion of enrollment for the Phase III ABTECT trials in patients with moderately to severely active ulcerative colitis.

ABTECT Phase III Trials Update:

• Enrollment Completion: 1275 participants successfully enrolled into two Phase III pivotal studies across multiple clinical sites.
• Maintenance Study: To date, 597 of the 1111 participants—comprising both completers of the induction study and those who were randomized but discontinued during the induction phase—have been enrolled in Part 1 (the 'responder arm') of the 44-week maintenance trial. This exceeds the minimum enrollment required to meet the statistical power assumptions. The Maintenance Study will continue to enroll participants through completion of induction study (end of June 2025).
• Top-Line Results: Induction trials topline data expected in Q3 2025, with 44-week maintenance topline data expected in Q2 2026.
• Participant Characteristics: Blinded baseline data aligns with the target population identified in the Phase IIb UC study.
• Safety Monitoring: No new safety signals observed in the latest Data Safety Monitoring Board (DSMB) review conducted on April 25, 2025.
• Regulatory Strategy: Pending positive results, a New Drug Application (NDA) submission in the US is targeted for H2 2026.

Dr, 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.”

Dr. Fabio Cataldi, 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.".