Obefazimod - (ABTECT)

June 1, 2026: Abivax SA (PARIS: FR; NASDAQ: ABVX) reported positive topline results from the Phase 3 ABTECT 44-week randomized, double-blind, placebo-controlled maintenance trial (Study 107) of oral obefazimod (ABX464), a miR-124 enhancer, in adults with moderately to severely active ulcerative colitis who responded to 8-week ABTECT-1/ABTECT-2 induction (N=580 re-randomized).

At Week 44, both once-daily doses met the FDA primary endpoint of placebo-adjusted clinical remission: 25 mg ∆39.3% (50.8% vs placebo 10.4%; p<0.0001) and 50 mg ∆40.3% (51.3% vs 10.4%; p<0.0001). Both doses met all key secondary endpoints including endoscopic improvement/remission, HEMI, corticosteroid-free clinical remission, and sustained clinical remission (all p<0.0001).

Safety over 44 weeks was described as favorable with no new safety signals; no deaths were reported. TEAEs occurred in 50.0% (placebo), 58.0% (25 mg), and 71.8% (50 mg); discontinuations due to TEAEs were 6.8%, 2.6%, and 4.6%, respectively.

Abivax plans an FDA NDA submission for obefazimod in UC in late Q4 2026; Phase 2b Crohn’s disease induction topline data are expected mid-2027. Half-year 2026 financial results are scheduled for Sept. 21, 2026.