on ABIVAX (EPA:ABVX)
Abivax Reaches Key Enrollment Milestone in Phase 3 ABTECT Trial
Abivax has announced a significant milestone in its Phase 3 ABTECT clinical trial, designed to evaluate obefazimod for moderately to severely active ulcerative colitis (UC). The trial has enrolled 1,003 of the targeted 1,224 participants, achieving 82% of its enrollment goal. The company expects to complete enrollment by Q2 2025.
Top-line results from the 8-week induction trial are anticipated in Q3 2025, with the 44-week maintenance data projected for Q2 2026. Assuming positive outcomes, a New Drug Application (NDA) submission is planned for the latter half of 2026. Current participant data aligns with the target population from the Phase 2b trial, and no new safety concerns have been observed.
Marc de Garidel, CEO of Abivax, highlighted the swift progress of the trial and its potential to confirm obefazimod as a first-in-class oral treatment for UC, noting the significant unmet need it aims to address. CFO Didier Blondel affirmed the company’s financial stability through Q4 2025 without the need for additional funding.
R. P.
Copyright © 2025 FinanzWire, all reproduction and representation rights reserved.
Disclaimer: although drawn from the best sources, the information and analyzes disseminated by FinanzWire are provided for informational purposes only and in no way constitute an incentive to take a position on the financial markets.
Click here to consult the press release on which this article is based
See all ABIVAX news