Abivax’s Phase 3 ABTECT maintenance trial shows obefazimod achieved durable clinical remission in ulcerative colitis with favorable safety, supporting NDA submission in late 2026 and expansion into Crohn’s disease.
Written By: Disha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Abivax has reported positive topline data from the global Phase 3 ABTECT maintenance trial, strengthening obefazimod’s position as a potential new oral treatment for ulcerative colitis (UC). Both the 25 mg and 50 mg once‑daily doses achieved the primary endpoint of clinical remission at Week 44, with placebo‑adjusted differences of 39.3% and 40.3%, respectively (p<0.0001). Clinical remission was achieved in 50.8% of patients receiving 25 mg obefazimod and 51.3% receiving 50 mg, compared with 10.4% in the placebo arm.
The randomized, double‑blind, placebo‑controlled study enrolled 580 adults with moderately to severely active UC who achieved clinical response during the ABTECT‑1 (NCT05507203) and ABTECT‑2 (NCT05507216) induction trials. Participants were re‑randomized to receive obefazimod 25 mg, obefazimod 50 mg, or placebo for 44 weeks.
Secondary Endpoints and Efficacy Profile
Obefazimod met all key secondary endpoints, demonstrating broad and durable efficacy across multiple measures of disease control. Endoscopic improvement occurred in 54.9% of patients receiving 25 mg and 64.1% receiving 50 mg, compared with 12.5% in the placebo group. Endoscopic remission rates reached 41.5% and 47.7%, respectively, versus 9.9% with placebo.
The therapy also significantly improved histologic‑endoscopic mucosal outcomes, corticosteroid‑free clinical remission, and sustained clinical remission through Week 44. These findings support durable disease control and meaningful mucosal healing in patients with moderate‑to‑severe UC.
Safety and Tolerability
Obefazimod maintained a favorable safety profile, with no new safety signals reported during the study. No deaths, acute pancreatitis cases, or cardiac abnormalities suggestive of fibrosis were observed across treatment groups.
Serious treatment‑emergent adverse events occurred in 2.6% of patients receiving 25 mg obefazimod, 5.6% receiving 50 mg, and 4.2% receiving placebo. Rates of treatment discontinuation due to adverse events were low, at 2.6% and 4.6% in the 25 mg and 50 mg groups, respectively. Serious and opportunistic infections remained uncommon.
The findings build on previously reported long‑term open‑label extension data showing durable clinical remission and a favorable safety profile with up to seven years of obefazimod exposure.
Mechanism of Action
Obefazimod is a first‑in‑class oral small molecule that enhances microRNA‑124 (miR‑124), a natural regulator of inflammatory pathways. By increasing miR‑124 expression, the therapy helps restore immune balance and reduce chronic intestinal inflammation. The novel mechanism may provide an alternative option for patients who experience inadequate response or loss of efficacy with currently available therapies.
Clinical and Regulatory Outlook
Chief Executive Officer Marc de Garidel said the Phase 3 maintenance results reinforce obefazimod’s potential to deliver durable efficacy, favorable tolerability, and the convenience of once‑daily oral dosing.
Chief Medical Officer Fabio Cataldi emphasized that the growing body of clinical evidence supports obefazimod’s ability to address significant unmet needs in inflammatory bowel disease.
Abivax plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in late Q4 2026. The company is also advancing obefazimod in Crohn’s disease, with topline results from an ongoing Phase 2b induction trial expected in mid‑2027, potentially expanding its development across the broader inflammatory bowel disease spectrum.
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About the Writer
Disha Sanjay Jadhav (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.