PolyPid Ltd. announced positive topline results from its Phase 3 SHIELD II trial of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal colorectal surgery patients. The trial demonstrated a statistically significant 38% reduction in the primary composite endpoint and a 58% reduction in SSI rates compared to standard care. This achievement positions D-PLEX100 as a potentially leading prophylactic intervention in a market with significant unmet needs and high associated costs.
This news is highly relevant because SSIs represent a major challenge in colorectal surgery, leading to increased mortality risk, extended hospital stays, and substantial financial burden on the healthcare system. D-PLEX100’s demonstrated efficacy in significantly reducing SSI rates suggests a potential paradigm shift in post-surgical care, offering a much-needed solution for improving patient outcomes and reducing healthcare costs associated with these infections. The substantial reduction in SSI rates observed in the trial, from 9.5% to 3.8%, is particularly noteworthy, suggesting a potential for significantly improved patient care.
The SHIELD II trial involved 798 patients and achieved statistical significance across all endpoints. The primary composite endpoint included deep and superficial SSIs, all-cause mortality, and surgical reinterventions within 30 days of surgery. Key secondary endpoints further confirmed the efficacy of D-PLEX100, including a 58% reduction in SSI rates and a 62% reduction in patients with severe wound infections (ASEPSIS score > 20). The consistency of these results across multiple endpoints strengthens the clinical significance of the findings. PolyPid has secured FDA Fast Track, Breakthrough Therapy, and QIDP designations for D-PLEX100, indicating the FDA’s recognition of the drug’s potential to address this unmet medical need.
The positive Phase 3 results pave the way for PolyPid to advance D-PLEX100 towards commercialization. The company plans a pre-NDA meeting with the FDA by the end of 2025, followed by an NDA submission in early 2026 and a subsequent MAA submission in Europe. These results are also anticipated to accelerate ongoing discussions for global partnerships, potentially leading to broader market access and faster adoption of D-PLEX100. This signifies a crucial step towards potentially transforming the prevention of SSIs in abdominal colorectal surgery, offering a new standard of care and improved outcomes for patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
