Phase 3 ABTECT Trial Progress - The Phase 3 ABTECT trial evaluating obefazimod for moderately to severely active ulcerative colitis (UC) has enrolled 1,003 participants, representing 82% of the targeted 1,224 participants [2][5][6] - Enrollment completion is expected in Q2 2025, with top-line results for the 8-week induction trial anticipated in Q3 2025 [2][5][6] - The 44-week maintenance data is on track for Q2 2026, and if successful, an NDA submission is planned for H2 2026 [5][6] Company Strategy and Financial Position - The company's cash runway extends beyond the expected top-line results from the ABTECT induction trial and into Q4 2025, without the need for additional financing [4][5] - The company believes 2025 will be a pivotal year, with key data readouts and the advancement of its broader portfolio addressing chronic inflammatory conditions [3] Participant and Safety Data - Blinded baseline characteristics of participants align with the pre-specified target population and are consistent with the Phase 2b UC trial [5][6] - No new safety signals have been observed to date, with oversight from the independent Data Monitoring Committee [6] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod (ABX464), in Phase 3 clinical trials for UC [7]
Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment