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Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data
Globenewswireยท 2025-10-05 15:00
Core Insights - Abivax announced results from the Phase 3 ABTECT 8-Week Induction Trials for obefazimod, aimed at treating moderate-to-severely active ulcerative colitis, during the UEG Meeting in Berlin [2][3] - The trials demonstrated significant clinical remission rates and safety data, highlighting the need for new therapies in this area [3][5] Group 1: Trial Results - A total of 1,272 patients were enrolled in the ABTECT 1 & 2 trials, with a pooled clinical remission rate of 16.4% (p<0.0001) at the 50 mg once-daily dose at Week 8 [3][5] - ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001), while ABTECT-2 demonstrated a rate of 13.4% (p=0.0001) at the same dosage [3][5] - All key secondary efficacy endpoints were met in both trials, indicating robust performance of obefazimod [5] Group 2: Safety Profile - No signals for serious, severe, or opportunistic infections or malignancies were observed in the trials [3][5] - The most commonly reported treatment-emergent adverse events (TEAEs) included headache (16% at 25 mg, 24.1% at 50 mg) and nausea (5% at 25 mg, 7.2% at 50 mg), with low discontinuation rates due to headaches [3][5] Group 3: Future Developments - Abivax plans to present a second late-breaking abstract on October 6, 2025, and will host a conference call to discuss the topline results [4][5] - The company is focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [2][6]