Abivax Posts Positive Phase 3 Data for Ulcerative Colitis Drug
Late-breaking trial results for obefazimod show significant efficacy, positioning the first-in-class oral therapy in a competitive market.
Abivax S.A. (ABVX) delivered a significant pre-market catalyst, announcing positive late-breaking results from its Phase 3 ABTECT clinical trial for obefazimod, its investigational treatment for moderately to severely active ulcerative colitis (UC).
The data, presented on a Sunday, revealed that the first-in-class oral therapy achieved a statistically significant 16.4% placebo-adjusted clinical remission rate after an 8-week induction period (p<0.0001). , signaling a major step forward for the novel drug candidate.
Obefazimod operates via a unique mechanism as a first-in-class oral miR-124 enhancer, a microRNA known to be a natural regulator of inflammation. The therapy is designed to provide a durable anti-inflammatory response by essentially 'shutting off inflammation at the source.' This distinct approach could differentiate it in a crowded market, particularly for patients who have not responded to existing advanced therapies, including JAK inhibitors, a population well-represented in the ABTECT trial.
The potential market for ulcerative colitis treatments is substantial, with forecasts projecting the sector to reach $10 billion in major markets by 2031. , with some peak sales estimates reaching as high as $4 billion should it also gain approval for Crohn's disease. The positive data positions Abivax to compete with established players like AbbVie, Johnson & Johnson, and Eli Lilly, who are all active in the inflammatory bowel disease space.
The company confirmed a favorable and consistent safety profile for obefazimod, with no new safety signals detected during the trial. This is a critical factor as it advances toward regulatory review.
Looking ahead, Abivax is continuing its 44-week maintenance trial for the ABTECT program, with results anticipated in the second quarter of 2026. Pending positive outcomes from that phase, in the U.S. and Europe in the latter half of 2026. The successful induction data provides a strong foundation for these next steps, offering a potential new oral treatment option for patients suffering from ulcerative colitis.