PolyPid Announces Positive Topline Results from Phase 3 SHIELD II Trial: D-PLEX₁₀₀ Demonstrated Significant Reduction in Surgical Site Infections and Successfully Met Primary and All Key Secondary Endpoints

Core Insights - PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100, demonstrating its efficacy in reducing surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions [1][3][4] - The trial met all primary and secondary efficacy endpoints, showing a 58% reduction in SSI rates compared to standard of care [3][4] - The company plans to submit a New Drug Application (NDA) to the FDA in early 2026, with a Marketing Authorization Application (MAA) in the EU to follow [1][3] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [11] - The lead product candidate, D-PLEX100, utilizes Polymer-Lipid Encapsulation technology for prolonged and controlled release of antibiotics at the surgical site [9][11] - D-PLEX100 has received Breakthrough Therapy designation from the FDA for the prevention of SSIs in elective colorectal surgery [10] Trial Details - The SHIELD II trial was a multinational, randomized, double-blind Phase 3 study assessing the efficacy and safety of D-PLEX100 in preventing post-surgical infections [8] - The primary endpoint included a combination of deep and superficial SSIs, all-cause mortality, and surgical reinterventions within 30 days post-surgery [4][8] - The trial enrolled patients across the United States, Europe, and Israel, with a total of 975 patients included in the analysis [8] Efficacy Results - D-PLEX100 demonstrated a 38% reduction in the primary endpoint events compared to standard of care [4] - Key secondary endpoints showed a 58% reduction in SSI rates and a 62% reduction in patients with an ASEPSIS score greater than 20 [4][6] - No safety concerns were raised by the independent Data Safety Monitoring Board during the trial [4][6] Market Potential - The total addressable U.S. market for D-PLEX100 is estimated to exceed 12 million annual surgeries, indicating a significant unmet need [1] - The positive trial results are expected to catalyze global partnership discussions and enhance the product's market impact [1][3]