- PolyPid's D-PLEX100 showcases a 38% reduction in surgical site infections (SSIs), mortality, and reinterventions in Phase 3 trial.
- Significant 58% reduction in SSI rates achieved (p
- Plans for FDA submission set for early 2026; no safety concerns reported.
PolyPid Ltd. (PYPD, Financial), a late-stage biopharma company, has announced positive topline results from its SHIELD II Phase 3 trial of D-PLEX100. The trial demonstrated a significant 38% reduction in the occurrence of surgical site infections (SSIs), mortality, and surgical reinterventions with D-PLEX100 in combination with standard care, compared to standard care alone.
In the trial, key secondary endpoints were also achieved, including a 58% reduction in SSI rates (3.8% for D-PLEX100 plus standard care vs 9.5% for standard care, p
Importantly, no safety concerns were identified by the independent Data Safety Monitoring Board during the study, further reinforcing the potential utility and safety profile of D-PLEX100. PolyPid plans to submit a New Drug Application (NDA) to the FDA in early 2026, followed by a Marketing Authorization Application (MAA) in the European Union.
As part of ongoing efforts to bring the drug to market, PolyPid has announced plans to advance global partnership discussions based on the robust data, positioning D-PLEX100 as a potentially significant player in the wider surgical care landscape.
