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# Abivax Favorable Data in Ulcerative Colitis Trials
- URL: https://www.fdaweb.com/abivax-favorable-data-in-ulcerative-colitis-trials/
- Published: 2025-07-24T12:00:00.000Z
- Updated: 2026-09-14T15:17:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159562

Abivax is announcing favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in moderately to severely active ulcerative colitis (UC) patients. Both trials met their primary endpoint, demonstrating statistically significant rates of clinical remission at eight weeks with the once-daily 50 mg dose of obefazimod, according to the company. In ABTECT-1, the placebo-adjusted remission rate reached 19.3%, while ABTECT-2 showed a rate of 13.4%. All key secondary efficacy endpoints were also met.

Abivax also says the 25 mg dose met the FDA primary endpoint in ABTECT-1 with a 21.4% placebo-adjusted remission rate. It notes that this dose did not reach statistical significance in ABTECT-2, and the pooled data showed a placebo-adjusted clinical response rate of 28.6%, suggesting potential benefit with longer treatment duration.

Obefazimod is described by the company as a first-in-class miR-124 enhancer designed to stabilize immune responses by modulating inflammation at the RNA level. The therapy is being studied in patients with inadequate response, loss of response, or intolerance to conventional and advanced treatments, including biologics and JAK inhibitors. According to the company, the ABTECT program includes the largest Phase 3 population of UC patients with prior JAK inhibitor failure.