Core Insights - Abivax has presented new preclinical and clinical data for obefazimod, demonstrating its anti-fibrotic potential and favorable safety profile for treating inflammatory bowel disease at ECCO 2026 [2][3] Group 1: Clinical Data and Efficacy - The data presented includes evidence of obefazimod's anti-fibrotic effects in both preclinical human fibroblast models and in vivo animal models, indicating its potential to address unmet needs in Crohn's disease [4] - A pooled analysis from the Phase 3 ABTECT induction trials shows that obefazimod leads to symptomatic response as early as week 1 and symptomatic remission by week 2, with a nominally significant p-value of <0.05 [4][5] - Obefazimod demonstrated a ~50% reduction in a biomarker of active fibrosis (Pro-C3) and a ~30% reduction in a fibroblast activation marker (⍺SMA) in preclinical models, both with p-values <0.0001 [5] Group 2: Safety Profile - The safety data from the ABTECT-1 and ABTECT-2 trials indicate that the rates of serious treatment emergent adverse events (TEAEs) were comparable across treatment groups, with Obe-50mg at 3.1%, Obe-25mg at 2.2%, and placebo at 3.2% [8] - TEAEs leading to study discontinuation were also similar across groups, with Obe-50mg at 4.7%, Obe-25mg at 1.9%, and placebo at 4.1% [8] Group 3: Mechanism of Action - Biomarker data from the trials indicate that obefazimod enhances the expression of miR-124 and reduces key inflammatory cytokines IL-17A and IL-6 towards homeostatic levels, supporting its mechanism of action in restoring immune balance [4][8] - The mechanism allows for partial reduction of inflammatory cytokines without completely blocking these pathways, which may be beneficial for long-term disease management [8]
Abivax Presents First Evidence of Anti-Fibrotic Activity for Obefazimod Alongside New Clinical Efficacy and Safety Analyses in Inflammatory Bowel Disease at ECCO 2026