Acticor Biotech provides an update on the US regulatory discussion with the FDA

Paris, France, December 23, 2022 08:00 am CET - Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, is discussing with FDA to set up a Type C meeting for early 2023 with the same objective as for the recent meeting with the European Agency EMA.

With this Type C meeting, Acticor Biotech intends to pursue the discussion with the FDA on its clinical development program. The objective will be to validate the design and statistical analysis of the international Phase 2/3 study, ACTISAVE to support a potential future marketing authorization application in the US, BLA (Biologic License Application), as it has been recently done with the EMA.

At the same time, although it was recognized by the FDA that acute ischemic stroke (AIS) is a serious condition and that glenzocimab development program is designed to demonstrate an effect on a serious aspect of the condition, additional clinical evidence is requested by the Agency to accept a Fast Track designation for glenzocimab, at this stage. This request for Fast Track designation was submitted to the FDA on October 11th, 2022 on the basis of the Phase 1b/2a ACTIMIS study results. The FDA acknowledged the conduct of the ongoing Phase 2/3 ACTISAVE and is encouraging Acticor Biotech to submit a new request for Fast Track with additional supportive data from the ACTISAVE study.

Gilles Avenard, Chief Executive Officer and founder of Acticor Biotech, comments: We are pleased to have met our overall enrollment goals with over 180 patients included and will continue our efforts to enroll patients in our Phase 2/3 ACTISAVE study in the U.S. We are pursuing our discussions with the FDA, despite the negative outcome on the Fast Track designation, at this stage. This does not call into question the fundamentals of our positive Phase 1b/2a ACTIMIS results and the ongoing enrollment in our Phase 2/3 ACTISAVE study. The design of the ACTISAVE study was approved by the European Medicines Agency (EMA) at the end of the year, supporting a future marketing authorization application for glenzocimab in stroke. We are fully confident in the future of the clinical development of our program and pursue our discussions with regulatory authorities in Europe and the United States.

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