PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀

Core Insights - PolyPid Ltd. has successfully completed a Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health, marking the fourth consecutive successful inspection of its manufacturing facility [1][3] - This inspection confirms that PolyPid's facility meets the standards required for commercial production in the European market under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA) framework [2] - The company is preparing for a New Drug Application (NDA) submission for its lead product candidate D-PLEX₁₀₀ in early 2026, following positive results from the Phase 3 SHIELD II trial [3][5] Product Information - D-PLEX₁₀₀ is designed to provide local prolonged and controlled anti-bacterial activity at the surgical site to prevent surgical site infections (SSIs) [4] - The product utilizes Polymer-Lipid Encapsulation matriX (PLEX) technology to enable a continuous release of the antibiotic doxycycline for 30 days, targeting SSIs, including those caused by antibiotic-resistant bacteria [4] - In the Phase 3 SHIELD II trial, D-PLEX₁₀₀ achieved a statistically significant 58% relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions [4] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics [5] - The company has an innovative pipeline that includes products targeting oncology, obesity, and diabetes, in addition to D-PLEX₁₀₀ [5]