PolyPid Ltd. announced on June 9, 2025, positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal colorectal surgery patients with large incisions. The trial achieved statistically significant reductions across all primary and key secondary endpoints.
The primary efficacy endpoint, a composite of deep and superficial SSIs, all-cause mortality, and surgical reintervention, showed a significant 38% reduction (p<0.005) in the 798-patient intent-to-treat population. The first key secondary endpoint demonstrated a substantial 58% reduction (p<0.005) in deep and superficial SSI rates, decreasing from 9.5% to 3.8%.
The third key secondary endpoint, measuring patients with an ASEPSIS score greater than 20, showed a 62% reduction (p<0.05), indicating less severe infections. Additionally, the second key secondary endpoint, evaluating the composite of SSI, mortality, and reintervention in the full 975 randomized patient population, achieved a 36% reduction (p<0.005).
All patients in the trial received standard of care, which included prophylactic systemic antibiotics. Surgical site infections are estimated to cost the U.S. healthcare system up to $10 billion annually, extending hospital stays by an average of 9.7 days and increasing hospitalization costs by over $20,000 per patient admission.
PolyPid plans a pre-NDA meeting with the FDA by the end of 2025, followed by an NDA submission in early 2026 and a Marketing Authorization Application (MAA) submission in Europe shortly thereafter. D-PLEX100 holds Fast Track, Breakthrough Therapy, and Qualified Infectious Disease Product (QIDP) designations, with QIDP providing an additional five years of market exclusivity.
The total addressable U.S. market for D-PLEX100 is estimated at over 12 million annual surgeries. These robust Phase 3 results are expected to serve as a strong catalyst for advancing global partnership discussions for D-PLEX100 commercialization.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.