PARIS — Abivax SA disclosed preclinical data showing obefazimod’s potential to combat fibrosis in inflammatory bowel disease during 22 abstract presentations at the ECCO 21st Annual Congress, held this week in 2026. Researchers observed anti-fibrotic effects in a human fibroblast model and an in vivo animal model, according to lead author Professor Silvio Danese of IRCCS San Raffaele Hospital’s Gastroenterology and Digestive Endoscopy Unit.
Fibrosis represents a critical unmet need in Crohn’s disease, where scar tissue buildup damages bowel function over time. Obefazimod, Abivax’s lead candidate currently in Phase 3 for moderately to severely active ulcerative colitis, appeared to halt this process in lab settings. “Seeing data that address not only clinical response and safety, but also biological activity and fibrosis, is encouraging,” Danese said.
Safety stood out in a pooled analysis of the ABTECT-1 and ABTECT-2 induction trials. Rates of serious treatment-emergent adverse events and study discontinuations matched placebo levels, officials reported. Phase 3 enrolled patients with active ulcerative colitis; obefazimod treatment began yielding symptomatic responses by week 1, the earliest assessment point. Symptomatic remission emerged at week 2, with a nominally significant p-value under 0.05.
Biomarker results reinforced the drug’s mechanism. Obefazimod upregulated miR-124 in blood and colon tissue while cutting inflammatory cytokines IL-17A and IL-6 toward normal levels, per data from the induction trials. These shifts suggest obefazimod restores immune balance, a core aim of Abivax’s approach to chronic inflammation.
Marc de Garidel, Abivax CEO, highlighted the breadth of findings. “The strong data presented at ECCO reinforce obefazimod’s unique profile,” he said. “Taken together with additional clinical efficacy, safety, and biomarker data, they strengthen our confidence across UC and CD.” The company eyes Phase 3 maintenance trial results in Q2 2026 and Phase 2b ENHANCE-CD readout in Q4 2026.
Fabio Cataldi, chief medical officer, called the anti-fibrotic evidence compelling. “Fibrosis remains an area of profound unmet need,” he noted. “Combined with the favorable safety profile, this positions obefazimod as a compelling oral therapy.”
Subgroup analyses from ABTECT trials showed consistent activity across patient types. All 22 abstracts, including OP30 by Danese on anti-fibrotic activity, P0712 on safety by Seidler, P0923 on early symptoms by Armuzzi, and P0868 on biomarkers by Siegmund, appear on Abivax’s publications page.
Abivax, based in France and the U.S. and listed on Euronext Paris (ABVX) and Nasdaq (ABVX), targets immune-modulating therapies. Obefazimod disrupts RNA splicing to boost regulatory T-cells and miR-124, aiming to tame overactive immunity in IBD without broad suppression.
Presentations drew praise for addressing multiple disease facets. Long-term control and bowel preservation matter most for IBD patients, experts agree. Current therapies often fall short on fibrosis and rapid symptom relief.
Abivax plans regulatory submissions post-maintenance data. Investors watch closely as the company advances toward potential approval in ulcerative colitis, with Crohn’s expansion on deck.
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