PolyPid Ltd. announced positive topline results from its Phase 3 SHIELD II trial, showing D-PLEX100 significantly reduced surgical site infections (SSIs) in patients with large abdominal incisions. The treatment achieved a 58% reduction in SSIs, a 38% reduction in the composite primary endpoint (SSIs, mortality, and reinterventions), and a 62% reduction in severe wound infections. This success validates PolyPid’s PLEX technology platform, offering a localized, sustained-release antibiotic delivery method.
This news is potentially transformative for surgical infection prevention. Current prophylactic antibiotic strategies struggle to achieve adequate tissue penetration at surgical sites, leading to high SSI rates, particularly in high-risk procedures like colorectal surgeries. D-PLEX100’s localized delivery overcomes this limitation, offering a significant improvement in patient outcomes and potentially reducing reliance on systemic antibiotics, a key factor in combating antimicrobial resistance. The positive results could also lead to significant cost savings for healthcare systems burdened by the substantial expenses associated with SSIs, including extended hospital stays and additional interventions.
The SHIELD II trial enrolled 975 patients with incisions ≥7 cm, including a subset of 798 patients with large abdominal incisions. D-PLEX100 demonstrated efficacy across both groups, suggesting broader applicability beyond the initial target population. The drug utilizes a fraction of the doxycycline dose compared to systemic formulations (55-164 mg vs. 6,000 mg), achieving high local concentrations while minimizing systemic exposure. PolyPid estimates a potential US market of over 12 million annual surgeries, including hernia repairs, appendectomies, and colorectal surgeries. The company is planning regulatory submissions in early 2026 and exploring commercialization partnerships. Beyond D-PLEX100, PolyPid’s PLEX technology is being explored for other applications, such as localized chemotherapy delivery for solid tumors (OncoPLEX program).
The SHIELD II results suggest D-PLEX100 could become a new standard of care in preventing SSIs, particularly in high-risk surgical procedures. This achievement has broad implications, potentially improving patient outcomes, reducing healthcare costs, and offering a valuable tool in the fight against antimicrobial resistance. The validation of the PLEX technology platform opens further avenues for localized drug delivery in various therapeutic areas. The upcoming regulatory submissions and commercialization partnerships will be crucial steps in realizing the full potential of this promising technology.
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.
