PESG Research Update: PolyPid's SHIELD II Trial Delivers Transformative Phase 3 Topline Results - Paradigm Shift in Surgical Infection Prevention

Core Insights - PolyPid Ltd. announced significant topline results from the SHIELD II Phase 3 trial, showing that D-PLEX100 effectively reduces surgical site infections (SSIs) [1][2][18] - The study demonstrated a 58% reduction in SSIs, a 38% reduction in the composite primary endpoint, and a 62% reduction in severe wound infections, validating the PLEX technology platform [2][6][18] Clinical Efficacy - The SHIELD II trial involved 798 patients with large abdominal incisions, achieving a 38% reduction in the composite primary endpoint (10.9% vs 18.1% in the control arm, p<0.005) [6] - D-PLEX100 treatment resulted in a 58% reduction in deep and superficial SSIs (3.8% vs 9.5% in the control arm, p<0.005), indicating a significant improvement in infection rates [6][7] Technology Validation - The results validate PolyPid's PLEX technology, which allows for sustained, localized antibiotic delivery for 30 days at surgical sites [8][9] - D-PLEX100 uses only 55-164 mg of doxycycline compared to 6,000 mg in systemic formulations, addressing limitations of current prophylactic strategies [9] Market Impact - SSIs affect up to 30% of colorectal surgeries, leading to extended hospital stays and direct costs of $11,000-26,000 per infection; the 58% reduction in SSI rates could lead to significant healthcare cost savings [11] - PolyPid targets a total addressable U.S. market of over 12 million annual surgeries, with potential for label expansion beyond colorectal indications [15] Regulatory Pathway - PolyPid plans to submit regulatory filings for FDA New Drug Application (NDA) and European Medicines Agency Marketing Authorization Application (MAA) in early 2026 [12] - The FDA has previously assigned Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations to D-PLEX100, facilitating expedited review [13] Broader Implications - The SHIELD II results not only support D-PLEX100 but also validate the broader PLEX technology platform for future therapeutic applications, including localized chemotherapy delivery [16][17] - The successful demonstration of clinical efficacy opens new possibilities for addressing unmet medical needs across various therapeutic areas [19][20]