Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Induction Trial Results in Participants With and Without Prior Inadequate Response to Advanced Therapies
October 6, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Abivax, UEG Week 2025, UEG Week2025, chronic inflammatory diseases, clinical trials, ulcerative colitis, vaccines
- 50 mg dose of once-daily obefazimod achieved clinically meaningful improvements, across all endpoints, regardless of prior inadequate response to advanced therapies (AT-IR)
- 50mg dose demonstrated clinically meaningful improvements in clinical remission in participants with and without prior inadequate response to up to 4+ lines of advanced therapies including JAK inhibitors in the pooled ABTECT 1 & 2 Trials (w/AT-IR pbo adjusted D 10%, p=0.0009†; w/o AT-IR pbo adjusted D 22%, p<0.0001†)
- 50mg obefazimod demonstrated clinically meaningful improvement in clinical response in participants with no prior AT-IR (pbo adjusted D 28%, p<0.0001†) and in participants with 4 or more prior AT-IR (pbo adjusted D 29%, p=0.0242†)
- 50mg obefazimod demonstrated clinically meaningful improvements in clinical response in participants with prior failure to JAK inhibitor therapy in the pooled ABTECT 1 & 2 Trials (pbo adjusted D 34%, p=0.0017†)
- 25mg and 50mg once-daily obefazimod performed similarly across clinical endpoints in patients who had no prior AT-IR
- Obefazimod treatment was well tolerated with no new safety signals identified for both the 25mg and 50mg doses
- Abivax Management to host a conference call today at 9:00 a.m. ET / 3:00 p.m. CET to discuss the results.
6 October 2025 — Paris, France — Abivax SA, a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced additional clinical data for obefazimod were delivered in a second late-breaking presentation at the United European Gastroenterology (UEG) Meeting in Berlin, Germany. These data, from the Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod for the treatment of moderate-to-severely active ulcerative colitis, highlight additional efficacy endpoint data at week 8 for patients with and without prior advanced therapy inadequate response (AT-IR).
“Despite advances in care, many patients with ulcerative colitis continue to struggle with inadequate disease control and safety concerns that significantly impact their quality of life,” said Silvio Danese, MD, PhD, Professor of Gastroenterology, IRCCS San Raffaele Scientific Institute, and UEG President Elect. “The outstanding results shared today demonstrate meaningful improvements across a spectrum of patients with ulcerative colitis, ranging from those who were naïve to advanced therapies to those who have failed up to 4+ lines of prior advanced therapy, including JAK inhibitors. Taken together with the clinically meaningful improvements across all efficacy endpoints and a continued favorable safety profile, these findings highlight obefazimod’s potential in becoming the standard of care for treating a broad spectrum of patients with ulcerative colitis.”
About Abivax
Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Visit: www.abivax.com.
