PolyPid Ltd. hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100. Charles E. Edmiston, Ph.D. (Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), discussed several key topics surrounding SSIs.

Key takeaways include: The return to higher pre-COVID SSI rates due to the increase in the number of elective surgeries conducted and the surgical environment normalizing to levels found prior to 2020. SSIs are under-reported, and up to 30-35% of colorectal infections are missed due to sub-optimal surveillance strategies. Procedural and patient-related risk factors such as smoking, alcohol abuse, type 2 diabetes and a high BMI have a significant negative impact on the risk of developing a SSI, and this increase in risk is compounded when patients have multiple risk factors.

Long term cost to commercial payers of a single colorectal SSI event over a period of 24 months can range from $44,000 (superficial SSI) to $64,000 (deep SSI), with the cost for Medicare ranging from $20,000 to $45,000, respectively. Surgical care bundles in patients undergoing colorectal surgery significantly reduce the risk of SSIs. The 30-day high concentration release of antibiotics achieved with D-PLEX100 has the potential to add additional benefit to infection prevention bundles.

PolyPid also provided an update on the enrollment of its ongoing Phase 3 SHIELD II trial of its lead product candidate, D-PLEX100. The SHIELD II clinical study includes patients undergoing abdominal colorectal surgery with large incisions and has now enrolled approximately 250 patients of a planned total of approximately 600 subjects. Approximately 50 centers are currently open and recruiting patients.

Top-line results are expected in the first quarter of 2025. The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is anticipated to occur in the fourth quarter of 2024.