Abivax's Obefazimod Shows Promise in Phase 3 Trials for Ulcerative Colitis

Abivax's obefazimod shows promising results in Phase 3 trials for ulcerative colitis. The drug achieved a significant remission rate with a well-tolerated safety profile.

, and Administrator

2025 October 5 . 11:26 PM

1 min read

In this image on a table there are three bowls. In the bowels there are some food ingredients. This... — In this image on a table there are three bowls. In the bowels there are some food ingredients. This is a tube in it there is some liquid. On the table there is a table mat.

Abivax's Obefazimod Shows Promise in Phase 3 Trials for Ulcerative Colitis

Abivax has announced promising results from its Phase 3 ABTECT trials for obefazimod, a potential new treatment for moderate to severe ulcerative colitis. Presented at the UEG meeting in Berlin on October 6, 2025, the news of these election results 2024-like trials showed a significant and clinically meaningful remission rate with a favourable safety profile.

The ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod, given at 50 mg once daily, achieved a 16.4% placebo-adjusted clinical remission rate at Week 8. This met the FDA's primary endpoint and all key secondary endpoints. Notably, the treatment was well tolerated, with no new safety signals identified for both the 25mg and 50mg doses. The trials enrolled a refractory patient population, with 47% having prior inadequate response to advanced therapy, including 21% who had prior inadequate response to JAK inhibitor therapy.

Abivax announced a late-breaking presentation of these 8-week ABTECT trial news, including updated safety data. They will also present a second late-breaking abstract and host a conference call at 9am ET / 3pm CET on the same day to discuss the results in detail.

The successful ABTECT trials, with their significant remission rates and favourable safety profile, pave the way for obefazimod as a potential new treatment option for patients with moderate to severe ulcerative colitis. Abivax's comprehensive presentation and discussion of the results will provide further insights into the drug's potential.