Abivax Société Anonyme Approval for Abx464 Phase 1 Study in Japanese Subjects for Subsequent Inclusion of Japan into the Global Phase 3 Program in Ulcerative Colitis
August 17, 2021 at 05:00 pm
Abivax SA announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved a phase 1 clinical trial to be conducted with ABX464 in healthy Japanese volunteers. This trial is required as part of the common clinical development plan to confirm the pharmacokinetic (PK) profile of ABX464 in Japanese subjects. Given positive results of this phase 1 study, Abivax will be able to include Japanese patients in its global phase 3 clinical development program of ABX464 for the treatment of ulcerative colitis.