Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis
- 50 mg once-daily dose of obefazimod led to a compelling pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8 in the ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials. Individually, the 50 mg dose demonstrated a placebo-adjusted remission rate of 19.3% (p<0.0001) in ABTECT-1 and a placebo-adjusted remission rate of 13.4% (p=0.0001) in ABTECT-2.
- 50 mg once-daily dose of obefazimod met all key secondary endpoints demonstrating highly statistically significant and clinically meaningful benefits.
- ABTECT included a well-balanced distribution of advanced therapy naïve and advanced therapy experienced participants, with 47.3% of participants having had inadequate response to prior advanced therapy, including the largest population of patients with inadequate response to JAK inhibitor therapy in Phase 3 UC trials to date.
- Obefazimod demonstrated favorable tolerability results, with no new safety signals observed. The treatment was generally well tolerated across both dose groups.
- The ABTECT Maintenance Trial (ABX464-107) is ongoing with top-line results expected to report out in Q2 2026. Among the 1,275 patients randomized in the induction trials, 678 achieved clinical response and enrolled into part 1 of the maintenance trial. The ABTECT program is one of the largest Phase 3 ulcerative colitis trials ever conducted.
- Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results.
PARIS, France – July 22, 2025 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), 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 positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials evaluating its oral, first-in-class miR-124 enhancer, obefazimod (ABX464), in adult patients with moderately to severely active ulcerative colitis (“UC”).
Marc de Garidel, Chief Executive Officer of Abivax, commented: “Today marks a significant milestone for Abivax, and more importantly, for the ulcerative colitis community. The strength of these results reinforces our belief in obefazimod, our first-in-class miR-124 enhancer, and its potential to become a transformative new treatment modality for patients with UC. Pending successful results from the 44-week maintenance trial, we are preparing to submit a New Drug Application to the FDA in the second half of 2026. We would like to thank the patients who participated in the trials as well as the investigators and staff at over 600 sites in 36 countries who contributed to the landmark trials.”
David Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, commented: “The results of the two induction studies for this first-in-class therapy for ulcerative colitis are both statistically significant and clinically meaningful. Based on the impressive safety and tolerability profile demonstrated to date, and pending similar results in the maintenance study, obefazimod will offer a welcome new option for those who suffer from ulcerative colitis, both as an attractive early option as well as for those who have had inadequate response or loss of response to prior advanced therapies.”
