PolyPid Announces Recruitment of First Patient in Revised SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections
| Source: PolyPid Ltd.
Company Recently Reached Agreement with FDA on Design of Trial
Top-line Results Expected in Mid-2024
PETACH TIKVA, Israel, June 22, 2023 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today 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 (SSIs). The U.S. Food and Drug Administration (FDA) recently accepted the Company’s revised protocol for SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions (> 20 cm).
SHIELD II will enroll an estimated 550 additional patients beyond the 40 patients already recruited into the trial. Total recruitment time into the trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up.
“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.”
About SHIELD II
SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing surgeries with incisions greater than 20 cm. The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.