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# Abivax Positive Data with Ulcerative Colitis Drug
- URL: https://www.fdaweb.com/abivax-positive-data-with-ulcerative-colitis-drug/
- Published: 2025-10-06T12:00:00.000Z
- Updated: 2026-09-14T15:23:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159992

Abivax is announcing new Phase 3 data showing that its lead drug candidate, obefazimod, achieved clinically meaningful improvements across all efficacy endpoints in patients with moderately to severely active ulcerative colitis — including those who had previously failed multiple advanced therapies.

The results, presented at the United European Gastroenterology Meeting in Berlin, come from the eight-week induction phase of the ABTECT-1 and ABTECT-2 trials, which together enrolled 1,272 participants. About 47% of patients had an inadequate response to prior advanced therapy, including biologics, JAK inhibitors, and S1P modulators.

In the pooled analysis, once-daily obefazimod 50 mg showed statistically significant and clinically meaningful improvements in clinical remission and response, regardless of prior treatment history, according to the company. In those with four or more prior therapy failures, the difference was 29%, and among participants with prior JAK inhibitor failure, obefazimod achieved a 34% placebo-adjusted difference, it adds.