(Boursier.com) — Abivax lost 2.2% to 7.92 euros on Friday, while the company received approval from the central ethics committee in the United States (IRB – Institutional Review Board) allowing the initiation of patient recruitment in the United States. United 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.
Following the responses provided by the US regulatory agency, the FDA, as part of the “End-of-Phase-2 Meeting” and the European regulatory agency, the EMA, during its scientific opinion received at the end of 2021, Abivax submitted to the FDA in June 2022, as part of the IND (Investigational New Drug (IND) Application), the final protocols for the phase 3 clinical studies as well as all the required information.
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.
“The schedule for phase III is coming together, which is very good news for the company,” comments Portzamparc. “However, the concern about financial visibility, which becomes critical at this stage, persists… As a reminder, Abivax plans to include 1,200 patients in its phase III study. This brings the cost of the latter to nearly 200 ME” underlines the analyst.
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