India, July 23 -- Abivax SA (ABVX) has announced positive topline results from its phase III induction trials of its investigational drug Obefazimod in adult patients with moderately to severely active ulcerative colitis, sending its shares surging more than 400% in premarket trading.
The 8-week phase III trials, dubbed ABTECT-1 and ABTECT-2, were conducted simultaneously and have enrolled 1,275 adult patients with moderately to severely active ulcerative colitis. The studies evaluated once-daily oral administration of Obefazimod at doses of 25 mg or 50 mg.
The primary efficacy endpoint, i.e., the clinical remission as defined by the modified Mayo Score, per FDA requirements, is evaluated at week 8 for induction and at week 44 for mainten...