Abivax reports positive Phase 3 ABTECT 8-week induction results for obefazimod in ulcerative colitis
核心洞察
Abivax reported positive topline results from the Phase 3 ABTECT-1 and ABTECT-2 induction trials of oral obefazimod in moderately to severely active ulcerative colitis (搜索).
The 50 mg once-daily dose produced a pooled placebo-adjusted clinical remission rate of 16.4% at Week 8, with 19.3% in ABTECT-1 and 13.4% in ABTECT-2.
No new safety signals emerged across either dose group, and Abivax plans NDA and MAA submissions in the second half of 2026 if the maintenance trial reads out positively.
Abivax announced positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials of obefazimod (ABX464), an oral first-in-class miR-124 (搜索) enhancer, in adults with moderately to severely active ulcerative colitis (搜索). The 50 mg once-daily dose met the FDA primary endpoint of clinical remission at Week 8 in both trials, with a pooled placebo-adjusted remission rate of 16.4% (p<0.0001). Individually, the placebo-adjusted rate was 19.3% (p<0.0001) in ABTECT-1 and 13.4% (p=0.0001) in ABTECT-2, and all key secondary endpoints were met at that dose.
The 25 mg once-daily dose reached the primary endpoint in ABTECT-1 with a placebo-adjusted remission rate of 21.4%, but did not achieve statistical significance in ABTECT-2, where it produced a pooled placebo-adjusted clinical response rate of 28.6%. The two trials randomized 1,275 patients across more than 600 sites in 36 countries, with 47.3% having had inadequate response to prior advanced therapy, including the largest Phase 3 ulcerative colitis (搜索) population with inadequate response to JAK (搜索) inhibitor therapy to date. Obefazimod was generally well tolerated across both dose groups with no new safety signals.
Of the 1,275 randomized patients, 678 achieved clinical response and entered part 1 of the ongoing ABTECT maintenance trial (ABX464-107), with topline results expected in Q2 2026. Contingent on positive 44-week maintenance data, Abivax intends to submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA in the second half of 2026.
Source: EQS-News / Abivax