Abivax says obefazimod met primary endpoint in ABTECT-1, ABTECT-2 trials

Abivax (ABVX) announced “positive” topline results from its Phase 3 ABTECT-1 and ABTECT-2 8-week induction trials evaluating its oral, first-in-class miR-124 enhancer, obefazimod, in adult patients with moderately to severely active ulcerative colitis. The ABTECT-1 and ABTECT-2 induction trials are global, multicenter, randomized, double-blind, placebo-controlled trials assessing once-daily oral administration of obefazimod at 25 mg or 50 mg doses in adult patients with moderately to severely active UC. Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimens for both trials. Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% and ABTECT-2 demonstrated 13.4%, each at the 50 mg once-daily dose, with all key secondary efficacy endpoints being met. The 25 mg once-daily dose of obefazimod achieved the FDA primary endpoint of clinical remission at Week 8 in ABTECT-1 demonstrating a placebo-adjusted remission rate of 21.4%. While the 25 mg dose did not achieve statistical significance for this endpoint in ABTECT-2, it achieved a pooled placebo-adjusted clinical response rate of 28.6%, indicating a strong signal for these patients to achieve clinical remission with extended treatment in the maintenance trial. The safety profile of obefazimod remained consistent with prior clinical experience. No new safety signals were observed in either trial and the treatment was generally well tolerated across both dose groups. Topline maintenance results are expected in Q2 2026, which are intended to support regulatory filings globally. Contingent on positive 44-week maintenance results, Abivax intends to submit a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in the second half of 2026.