(Boursier.com) — Acticor Biotecha clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of cardiovascular emergencies, particularly stroke, is discussing with the US Food & Drug Administration (FDA) to organize a Type C meeting in beginning of 2023, with the same objective as for the recent meeting with the European Medicines Agency, the EMA.
With this type C meeting, Acticor Biotech intends to continue the discussion with the US 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, in order to support a potential future application for marketing authorization in the United States, BLA (Biologic License Application), as was done recently with the EMA.
At the same time, although the FDA has recognized that acute ischemic stroke is a serious disease and that the glenzocimab development program is designed to demonstrate an effect on a severe aspect of the disease, the Agency has requested additional clinical evidence before accepting, at this stage, a “Fast Track” designation for glenzocimab.
This request for “Fast Track” designation was submitted to the FDA on October 11, 2022 based on the results of the phase 1b/2a ACTIMIS study. The FDA, which has recognized the conduct of phase 2/3 ACTISAVE, encourages Acticor Biotech to submit a new application for “Fast Track” with additional data from the ACTISAVE study.
Gilles Avenard, CEO and Founder of Acticor Biotech, commented: “We are pleased to have achieved our overall recruitment goals with over 180 patients enrolled and we will continue our efforts to recruit patients in our phase 2 study. /3 ACTISAVE in the United States. We are continuing our discussions with the American FDA, despite the negative feedback, at this stage, regarding the Fast Track designation. This decision in no way calls into question the fundamentals of the positive results of our phase 1b study. /2a ACTIMIS and ongoing recruitment in our phase 2/3 study ACTISAVE The design of the ACTISAVE study was approved by the European Medicines Agency (EMA) at the end of the year, thus 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 are continuing our discussions with regulatory authorities in E Europe and the United States.”
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