PARIS, France, June 1, 2026
Abivax announced positive topline results from its pivotal Phase 3 ABTECT maintenance trial evaluating obefazimod, a first-in-class oral miR-124 enhancer, in adults with moderately to severely active ulcerative colitis (UC). The study achieved its primary endpoint, with both the 25 mg and 50 mg once-daily doses delivering highly significant improvements in clinical remission compared to placebo at Week 44. The results position obefazimod as a potential new treatment option for UC patients seeking durable disease control through a convenient oral therapy. Based on these findings, the company plans to submit a New Drug Application (NDA) to the U.S. FDA in late 2026.
Strong Clinical Remission and Key Secondary Endpoint Success
The global Phase 3 ABTECT maintenance study enrolled 580 patients who responded during the induction phase and were re-randomized to receive 25 mg obefazimod, 50 mg obefazimod, or placebo. At Week 44, the 25 mg dose achieved a 50.8% clinical remission rate, while the 50 mg dose achieved 51.3%, compared with only 10.4% for placebo. This translated into placebo-adjusted remission benefits of 39.3% and 40.3%, respectively, both reaching strong statistical significance (p<0.0001). Importantly, obefazimod also met all major secondary endpoints, including endoscopic improvement, endoscopic remission, histologic-endoscopic mucosal improvement (HEMI), corticosteroid-free clinical remission, and sustained clinical remission. The low placebo remission rate further highlights the strength of the efficacy results and underscores the therapy’s potential to deliver meaningful long-term disease control.
Favorable Safety Profile Supports Long-Term Treatment Potential
Obefazimod demonstrated a favorable safety and tolerability profile throughout the 44-week maintenance period, with no new safety signals identified. Most adverse events were manageable, and treatment discontinuation rates remained low. Serious infections were uncommon across treatment groups, and no deaths, acute pancreatitis cases, or cardiac abnormalities suggestive of fibrosis were reported. Investigators also noted that observed malignancy cases were considered unrelated to treatment and showed no evidence of organ-specific clustering. These findings align with previously reported long-term extension data demonstrating durable remission and safety with up to seven years of exposure, reinforcing confidence in obefazimod’s long-term benefit-risk profile.
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Regulatory Path Forward and Expansion Beyond Ulcerative Colitis
The positive Phase 3 results mark a major milestone for Abivax as it advances toward regulatory submission and potential commercialization. Company leadership emphasized that obefazimod’s novel mechanism of action, strong efficacy, durable remission rates, and once-daily oral administration could significantly reshape the treatment landscape for ulcerative colitis. Beyond UC, Abivax is also evaluating the therapy in Crohn’s disease, with topline Phase 2b induction trial results expected in mid-2027. If approved, obefazimod could emerge as one of the most significant new therapies in inflammatory bowel disease, offering patients a differentiated oral treatment option capable of maintaining long-term remission while preserving a favorable safety profile.
Source: Abivax press release
