Abivax SA announced that the US Food and Drug Administration (the FDA) provided their agreement on the initial Pediatric Study Plan (iPSP) for the development of obefazimod in ulcerative colitis in children from 2 to 17 years old. Following completion of End of Phase 2 Meeting, Abivax initiated a Phase 3 program (ABTECT program) with obefazimod in adults with moderate to severe ulcerative colitis, which includes patients aged 16 and over. Recognizing the impact of IBD in children and adolescents, Abivax is further committed to the pediatric development of obefazimod, starting with ulcerative colitis.

Obefazimod is currently in Phase 3 clinical trials for the treatment of ulcerative colitis ("ABTECT program") with the first patient enrolled in the United States on October 11, 2022. 1,200 UC patients across 36 countries will take part in the pivotal Phase 3 program that consists of two induction trials (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106)) and a single subsequent maintenance trial (ABX464-107). The ABTECT program aims to confirm obefazimod's potential to maintain and further improve patient-outcomes over time, as well as its favorable safety and tolerability profile, as already observed during previously conducted Phase 2a and Phase 2b clinical trials in moderate to severe UC.