BriefCast Publishes Transcript: PolyPid Ltd. SHIELD II Phase 3 Trial Topline Results Call Transcript

Core Insights - PolyPid Ltd. announced successful topline results from its SHIELD II Phase 3 trial of D-PLEX100, showing a 38% reduction in the primary composite endpoint and a 58% reduction in surgical site infection (SSI) rates from 9.5% to 3.8% compared to standard care alone [1][2][17] Trial Results - The SHIELD II trial included 798 patients and achieved statistical significance across all endpoints, with a p-value lower than 0.005 [1][15] - D-PLEX100 demonstrated a 58% reduction in SSI rates, positioning it among the most effective prophylactic interventions for abdominal colorectal surgery [2][17] - The trial's primary endpoint showed a 38% reduction in deep and superficial SSIs, all-cause mortality, and surgical reinterventions within 30 days of surgery [15][21] Market Implications - SSIs represent a significant burden on the U.S. healthcare system, costing up to $10 billion annually and increasing hospitalization costs by over $20,000 per patient [2][21] - PolyPid plans to hold a pre-NDA meeting with the FDA by the end of 2025, followed by NDA submission in early 2026, which is expected to expedite global partnership discussions for commercialization [2][22] Regulatory Designations - D-PLEX100 has received FDA Fast Track, Breakthrough Therapy, and Qualified Infectious Disease Product (QIDP) designations, enhancing its regulatory pathway and market exclusivity [2][22] Future Steps - The company is preparing to present its comprehensive dataset at major medical conferences to generate attention from the surgical community [23]