Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis

EQS-News: ABIVAX / Key word(s): Study Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis 29.04.2025 / 22:05 CET/CEST The issuer is solely responsible for the content of this announcement. Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis

• The Phase 3 ABTECT trials (Studies 105 and 106) evaluating obefazimod in patients with moderately to severely active ulcerative colitis successfully enrolled 1,275 participants, exceeding the target enrollment of 1,224 by 4%.
• Top-line results from the 8-week induction trials anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026.
• Blinded baseline characteristics align with pre-specified target population and are consistent with Phase 2b UC trial participant characteristics
• Cash runway through ABTECT induction trials readout and into Q4 2025

PARIS, France – April 29, 2025 – 10:05 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the completion of enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active ulcerative colitis.  

Marc de Garidel, Chief Executive Officer of Abivax, commented:
“Completing enrollment for our Phase3 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 Q32025, followed by comprehensive long‑term maintenance data in Q22026. 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.”