Abivax Reports Obefazimod Cuts Fibrosis Markers by 50% and Achieves Week 2 Remission
Abivax showed obefazimod cuts fibrosis markers by ~50% (Pro-C3) and ~30% (αSMA) in vitro and achieves up to 90% histologic fibrosis score reduction in vivo. In 1,272 Phase 3 patients, serious adverse events occurred in 2.2–3.1% and symptomatic remission was reached by week 2 (p<0.05).
1. Preclinical Findings
In a human fibroblast model obefazimod reduced Pro-C3 by ~50% and αSMA by ~30% (p<0.0001), while in vivo studies showed reductions up to 90% in histologic fibrosis score along with significant declines in disease activity index and collagen deposition.
2. Phase 3 Safety and Efficacy Analysis
A pooled analysis of 1,272 patients from Phase 3 ABTECT-1/2 induction trials showed serious treatment-emergent adverse event rates of 2.2–3.1% across treatment and placebo groups, discontinuation rates of 1.9–4.7%, and symptomatic remission achieved by week 2 (nominal p<0.05).
3. Biomarker and Mechanism Evidence
Biomarker analyses indicated upregulation of miR-124 and reductions in IL-17A and IL-6 toward homeostatic levels, supporting obefazimod’s mechanism in restoring immune balance in inflammatory bowel disease.
4. Future Milestones
Abivax expects a Phase 3 maintenance trial readout in Q2 2026 and a Phase 2b ENHANCE-CD trial readout in Q4 2026 as it advances obefazimod’s development for Crohn’s disease and ulcerative colitis.