PYPD - PolyPid wins positive response from FDA for D-PLEX100 development plan

The FDA has indicated that a single Phase 3 pivotal study was adequate to support the approval of D-PLEX100, the lead candidate of PolyPid (PYPD), for the prevention of surgical site infections ((SSIs)) in colorectal surgery.The FDA’s written responses were in response to a Type B meeting request made by PolyPid regarding its development plan for D-PLEX100.“We are thrilled with the acceptance of our proposed development plan for the potential approval of D-PLEX100, which also reduces overall anticipated costs for the program,” noted Amir Weisberg, PolyPid’s CEO.“We will use the responses provided to progress our SHIELD I trial which continues to enroll patients at the expected rate, with over 200 patients enrolled to date, and we anticipate the availability of top-line results by the end of 2021,” Weisberg added.In July 2020, the company initiated the SHIELD I study, a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial to evaluate D-PLEX100 for the

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PolyPid wins positive response from FDA for D-PLEX100 development plan