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PolyPid Announces Publication in International Journal of Surgery Highlighting Results of Phase 3 SHIELD I Trial of D-PLEX₁₀₀ in Prevention of Surgical Site Infections in Abdominal Colorectal Surgery
SHIELD I Study is One of the Largest Phase 3 Trials in the Prevention of SSIs in Colorectal Resection Conducted in Over a Decade Pre-Specified and Post-Hoc
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[{"type":"text","content":"SHIELD I Study is One of the Largest Phase 3 Trials in the Prevention of SSIs in Colorectal Resection Conducted in Over a Decade Pre-Specified and Post-Hoc Analyses Suggested that D-PLEX100 May Benefit Patients with Increased SSI Risk, Including Those with Lengthy Incisions SHIELD II Study, the Ongoing Second Phase 3 with D-PLEX100, Focuses on Patients with Large Surgical Incisions; Top-line Results Expected in Q1 2025 PETACH TIKVA, Israel, Oct. 21, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a publication in the International Journal of Surgery (IJS) titled, \"Effect of Local Prolonged-Release Incisional Doxycycline on Surgical Site Infection Prophylaxis in Abdominal Colorectal Surgery: The SHIELD I Randomized Clinical Trial.” The article highlights the full dataset from the first Phase 3 study (NCT04233424) of D-PLEX100, from which top-line results were announced in September 2022. “The overall infection rate in SHIELD I was significantly impacted by the COVID-19-related safety restrictions introduced in the surgical setting during the pandemic,” said Prof. Oded Zmora, Professor of Surgery at the Shamir Medical Center in Tel Aviv Israel, and President of the European Society of Coloproctology. “Given this unexpected change in baseline infection rate, the SHIELD I primary outcome became extraordinarily difficult to meet. For this reason, while the SHIELD I study did not achieve its primary endpoint, both pre-specified and post-hoc analyses suggested that D-PLEX100 may benefit patients at increased risk of surgical site infections (SSIs), including those with lengthy incisions. While SHIELD II is ongoing, the clinical data generated by D-PLEX100 to date suggest it may be a promising future adjunctive component of surgical care bundles.” A virtual KOL event hosted by the Company in June 2024, highlighted that procedural and patient-related risk factors, such as smoking, alcohol abuse, type 2 diabetes and a high BMI, are known to have a significant negative impact on the risk of developing an SSI, and this increase in risk is compounded when patients have multiple risk factors. During the presentation, Prof. Charles E. Edmiston, Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wi...