(CercleFinance.com) – Abivax announces that it has received the approval of the
central ethics committee in the United States allowing the initiation of patient recruitment in the United States in phase 3 induction studies with the drug candidate obefazimod (ABX464) in the treatment of ulcerative colitis.
The inclusion of a first patient is anticipated by the end of the third quarter of 2022.
In Europe, the clinical trial application for phase 3 protocols will be submitted in August 2022 in accordance with the New Clinical Trial Regulation. Approval of these studies is
expected in December 2022.
‘We are pleased that Abivax has received US Central Ethics Board approval for the protocols for Phase 3 induction studies which aim to confirm the efficacy and safety of obefazimod in adults with ulcerative colitis. moderate to severe hemorrhagic ‘, reacted the Prof. Hartmut J. Ehrlich, CEO of Abivax.