Abivax SA (ABVX) presented novel preclinical and clinical findings for obefazimod at the European Crohn's and Colitis Organization's (ECCO) 21st Annual Congress, further strengthening the evidence base for its development in inflammatory bowel disease. The data highlighted obefazimod's anti-fibrotic potential in Crohn's disease, its favorable safety profile, rapid onset of symptomatic relief, and its mechanism of action in restoring immune balance through upregulation of miR-124.
In preclinical studies, obefazimod demonstrated anti-fibrotic effects in both a human fibroblast model and an in vivo animal model. These findings suggest the therapy may help address a major unmet need in Crohn's disease by targeting fibrosis, a complication that can lead to strictures and surgery.
A pooled analysis of safety data from the ABTECT-1 and ABTECT-2 induction trials showed that obefazimod has a favorable safety and tolerability profile. Rates of serious treatment-emergent adverse events and study discontinuations were comparable to placebo, underscoring its potential as a well-tolerated therapy option.
Clinical efficacy was observed early in treatment. Symptomatic response was noted as soon as week 1, the first time point evaluated, and symptomatic remission was achieved by week 2. This remission was nominally significant with a p-value below 0.05 in pooled analyses of the ABTECT-1 and ABTECT-2 trials, highlighting obefazimod's rapid onset of action.
Biomarker data from the same trials provided further evidence of obefazimod's mechanism of action. Treatment was associated with upregulation of miR-124, a key regulator of immune balance, and reduction of inflammatory cytokines such as IL-17A and IL-6 toward homeostatic levels. These findings support obefazimod's role in restoring immune equilibrium in patients with Crohn's disease.
ABVX closed trading on February 20 at $130.35, up $0.11 or 0.08%. In after-hours trading, the stock rose further to $131.10, marking a gain of $0.75 or 0.58%.
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