PolyPid hosts KOL call, provides update on ongoing SHIELD II Phase 3 trial

PolyPid hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of surgical site infections. The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100. Charles E. Edmiston, Ph.D., 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 to $64,000, 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.