PolyPid Discusses Surgical Site Infection Prevention and SHIELD II Phase 3 Trial Update

Surgical Site Infections (SSIs) have seen a resurgence to pre-COVID levels, following an initial decline during the pandemic. This trend is attributed to the increased number of elective surgeries and the normalization of the surgical environment. SSIs are often under-reported, with up to 35% of colorectal infections going unnoticed due to inadequate surveillance methods. Risk factors such as smoking, alcohol abuse, type 2 diabetes, and high BMI significantly heighten the risk of SSIs, especially when multiple risk factors are present.

The financial implications of SSIs are substantial. Over 24 months, a single colorectal SSI event can cost commercial payers between $44,000 to $64,000, depending on the severity of the infection. For Medicare, these costs range from $20,000 to $45,000. Implementing surgical care bundles in colorectal surgeries can significantly reduce SSIs. D-PLEX100, a product developed by PolyPid Ltd., offers a high concentration release of antibiotics over 30 days, potentially enhancing infection prevention measures.

Dr. Charles E. Edmiston, Emeritus Professor of Surgery at the Medical College of Wisconsin, highlighted the benefits of traditional evidence-based interventions during perioperative and immediate postoperative periods. He emphasized that D-PLEX100 extends antibiotic presence beyond these periods, maintaining high doxycycline concentrations to inhibit common surgical pathogens. This prolonged release offers an opportunity to improve the standard care in colorectal surgeries, enhancing patient outcomes and reducing payer costs.

PolyPid Ltd. provided updates on its SHIELD II Phase 3 trial for D-PLEX100. This trial, involving patients undergoing abdominal colorectal surgery with large incisions, has enrolled approximately 250 out of a planned 600 subjects. Around 50 centers are currently recruiting patients. An unblinded interim analysis will be conducted once about 400 patients complete their 30-day follow-up, with top-line results expected in the first quarter of 2025.

SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a Phase 3 trial evaluating the efficacy and safety of D-PLEX100 alongside standard care, which includes systemic antibiotics. The primary endpoint is the proportion of subjects with SSIs, reinterventions, or mortality within 30 days post-surgery. The trial will monitor patient safety for an additional 30 days and enroll patients in the United States, Europe, and Israel.

D-PLEX100 is designed to provide prolonged, controlled antibacterial activity at the surgical site, preventing SSIs. The PLEX (Polymer-Lipid Encapsulation matriX) technology allows continuous doxycycline release for 30 days, maintaining high local drug concentrations. This approach is especially useful against antibiotic-resistant bacteria. The U.S. FDA has granted D-PLEX100 Breakthrough Therapy Designation for preventing SSIs in elective colorectal surgeries. Currently in Phase 3 trials, D-PLEX100 aims to reduce SSIs in abdominal colorectal surgeries.

PolyPid Ltd., listed on Nasdaq under PYPD, is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled-release therapeutics. The company's proprietary PLEX technology ensures precise drug delivery over extended periods. Beyond D-PLEX100, PolyPid is in preclinical stages for OncoPLEX, a treatment for solid tumors, beginning with glioblastoma.

This information underscores the ongoing efforts and developments in reducing SSIs and improving patient outcomes, reinforcing the potential of PolyPid's innovative solutions in advancing surgical care.