Clinical Phase 3 Program in UC
1,200 UC patients across 36 countries will take part in the pivotal phase 3 program that consists of two induction studies and a single subsequent maintenance study (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) induction trials and ABTECT maintenance trial (ABX464-107)).
These three pivotal studies are all randomized, double-blind, and placebo controlled, using independent, blinded review of the videotaped endoscopies. The primary efficacy endpoint, assessed at week 8 in the induction and at week 44 in the maintenance study, will be clinical remission according to the modified Mayo Score, as required by FDA.
In consultation with international regulators, including both the FDA and EMA, obefazimod 25mg and 50mg will be investigated in the ABTECT program for the treatment of UC in advanced therapies (AT) naïve and in AT-failure patients to support the future submission of marketing authorizations.
600 study sites will be participating in the studies, of which 25% will be located in North America, 42% will be initiated in Europe, 26% in Asia and 7% of the sites will be situated in other geographies.