PolyPid recruits first patient in revised SHIELD II Phase 3 trial of D-PLEX100

PolyPid announced that the first patient has been recruited and is scheduled for surgery in its revised SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections. The U.S. Food and Drug Administration recently accepted the Company’s revised protocol for SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions. SHIELD II will enroll an estimated 550 additional patients beyond the 40 patients already recruited into the trial. “The recruitment of the first patient in the revised SHIELD II trial represents a significant milestone for our promising late-stage D-PLEX100 development program and our company,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “The revised SHIELD II protocol is focused on the population of patients undergoing surgeries with large incisions, which showed a highly statistically significant reduction of 54% in SSIs in SHIELD I. To further de-risk the trial, SHIELD II will primarily be conducted in the best performing sites from SHIELD I as it relates to recruitment, patient monitoring and good clinical practice, and we have enhanced our internal clinical operations capabilities. We are excited to resume the SHIELD II trial and look forward to providing updates on its progress in the coming months.”