PolyPid announces topline results from Phase 3 SHIELD II trial

PolyPid (PYPD) announced topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA. “The positive results of our Phase 3 pivotal trial provide clear and compelling evidence of D-PLEX100’s ability to significantly reduce SSIs, a major burden on patients and healthcare systems, while improving clinical outcomes for both patients and physicians,” said Dikla Czaczkes Akselbrad, CEO. “D-PLEX100 has the potential to meaningfully lower costs for hospitals and payers, and we believe it will be a valuable addition to the standard of care. Targeting a total addressable U.S. market of over 12 million annual surgeries and a significant unmet need, D-PLEX100 has the potential to make a substantial market impact. We remain on track for an NDA submission in early 2026 and believe these robust data will serve as a strong catalyst for advancing our global partnership discussions. We are deeply grateful to the patients, principal investigators, and study teams who made this milestone possible.” Key findings from SHIELD II study include: The primary efficacy endpoint of the study was successfully met, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC, compared to SoC alone, representing a 38% reduction. The primary endpoint is the combination of deep and superficial SSIs, all-cause mortality and surgical reinterventions at the same incision of the original index surgery. SHIELD II included three key secondary endpoints: The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC compared to those who received SoC alone. The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone. This efficacy endpoint combined SSI, mortality and reintervention as evaluated in the primary endpoint. This endpoint was assessed in the overall study population of 975 patients with an incision greater than or equal to7 cm, including laparoscopic surgery patients enrolled prior to the 2023 trial protocol change. The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS1 score greater than20 in D-PLEX100 plus SoC arm compared to SoC alone arm (pless than0.05). The ASEPSIS score is a clinical tool used to objectively assess surgical wound infections. There were no safety concerns raised by the independent Data Safety Monitoring Board in SHIELD II.