PolyPid Announces FDA Agreement on the Design of SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections
Source: PolyPid Ltd.
Top-line Results Expected in Mid-2024
PETACH TIKVA, Israel, May 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 U.S. Food and Drug Administration (FDA) agreed to Company’s SHIELD II Phase 3 trial design evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The revised SHIELD II trial will recruit patients undergoing colorectal resection surgery with large incisions (> 20 cm).
Recruitment into the trial will resume imminently with the enrollment of an estimated 550 additional patients beyond the 40 patients already recruited into SHIELD II. Total recruitment time into the study 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.
“We are pleased with FDA feedback to our revised protocol and are excited to resume SHIELD II trial recruitment,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Importantly, we view SHIELD II as a de-risked Phase 3 trial given the more focused patient population in which we’ve already generated highly positive data in SHIELD I, and the fact that it will not be conducted within the tight COVID-related restrictions that were in place throughout the duration of SHIELD I. We are also leveraging the key learnings from the SHIELD I trial, including firm knowledge of the best performing sites from SHIELD I in terms of recruitment, patient monitoring and good clinical practice.”
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.