Abivax presented new preclinical and clinical data for its lead candidate obefazimod at the European Crohn’s and Colitis Organization’s 21st Annual Congress in Paris on February 21 2026. The company disclosed the first evidence that obefazimod can reduce intestinal fibrosis, a major unmet need in Crohn’s disease that currently has no approved anti‑fibrotic therapy.
Preclinical studies showed that obefazimod markedly lowered fibrosis markers, including collagen deposition and α‑smooth muscle actin, with reductions ranging from 45 % to 90 % depending on the model and timing of treatment initiation. The data support the drug’s mechanism of action as an oral enhancer of miR‑124, a microRNA that modulates immune responses and has anti‑inflammatory properties.
In the pooled Phase 3 induction trials, obefazimod produced rapid symptomatic relief, with a response rate observed as early as week 1 and remission achieved by week 2. Safety data remained favorable, with serious treatment‑emergent adverse events comparable to placebo and no new safety signals identified.
The presentation sets the stage for two key upcoming readouts: the Phase 3 maintenance trial scheduled for Q2 2026 and the Phase 2b ENHANCE‑CD trial slated for Q4 2026. Positive results from these studies could broaden obefazimod’s therapeutic portfolio and accelerate regulatory progress.
"The robust data presented at ECCO this week reinforce obefazimod’s unique and differentiated profile," said CEO Marc de Garidel. "Intestinal fibrosis is a major complication of Crohn’s disease that is not fully addressed by current therapies," added Chief Medical Officer Fabio Cataldi. He added, "We look forward to sharing these new insights on obefazimod’s anti‑fibrotic properties, alongside the expansive clinical data to demonstrate obefazimod’s potential efficacy and favorable safety profile in ulcerative colitis."
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