Core Insights - PolyPid Ltd. has successfully completed enrollment in the SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgery patients [1][2][3] - The company anticipates reporting top-line results by the end of Q2 2025 and plans to submit a New Drug Application (NDA) to the FDA if the results are positive [2][3] - D-PLEX100 utilizes PLEX technology for prolonged and controlled release of doxycycline, targeting surgical site infections, and has received multiple FDA designations [5][6] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [6] - The company is also in preclinical stages testing OncoPLEX for solid tumors, starting with glioblastoma [6] SHIELD II Trial Details - The SHIELD II trial is a multinational, randomized, double-blind Phase 3 study assessing the efficacy and safety of D-PLEX100 compared to standard of care in preventing post-surgical infections [4] - The primary endpoint is the proportion of subjects with surgical site infection events within 30 days post-surgery [4]
PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections