Abivax aces pair of phase 3 ulcerative colitis trials as end of cash runway looms

Abivax announced positive results from two large Phase 3 induction trials (ABTECT-1 and ABTECT-2) evaluating its oral miR-124 enhancer, obefazimod, for moderate to severely active ulcerative colitis123.

The 50 mg once-daily dose of obefazimod achieved a pooled, placebo-adjusted clinical remission rate of 16.4% at Week 8 (p<0.0001) across both trials13.

Individually, the 50 mg dose posted placebo-adjusted remission rates of 19.3% in ABTECT-1 and 13.4% in ABTECT-2, both statistically significant13.

Obefazimod also met all key secondary endpoints with highly significant and clinically meaningful benefits1.

The studies involved 1,275 patients across 600 sites in 36 countries, including a large proportion (47.3%) with prior inadequate responses to advanced therapies13.

No new safety signals were observed, and the treatment was generally well tolerated1.

Results are viewed as a crucial milestone as Abivax faces a looming end to its cash runway, with expectations for additional data from the ongoing maintenance study in 20261.

Sources:

1. https://www.stocktitan.net/news/ABVX/abivax-announces-positive-phase-3-results-from-both-abtect-8-week-4bv90ycahquo.html

2. https://firstwordpharma.com/story/5983026

3. https://www.investing.com/news/company-news/abivax-reports-positive-phase-3-results-for-ulcerative-colitis-drug-93CH-4146847