Abivax SA ( ABVX ) stock is skyrocketing on Wednesday after the clinical-stage biotechnology company announced overwhelmingly positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials for oral obefazimod (ABX464) in adult patients with moderately to severely active ulcerative colitis.
The Paris-based company achieved a significant breakthrough with its experimental treatment, which demonstrated impressive efficacy and offers new promise to patients afflicted with this chronic inflammatory bowel ailment.
The ABTECT-1 and ABTECT-2 induction trials are assessing once-daily oral administration of obefazimod at 25 mg or 50 mg doses in adult patients with moderately to severely active ulcerative colitis. ABTECT-1 and ABTECT-2 were conducted simultaneously and have enrolled 1,275 patients.
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Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimens for both trials.
Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p