PolyPid announced the completion of its rolling New Drug Application (NDA) submission to the FDA for D-PLEX100, its lead investigational therapy designed to prevent surgical site infections (SSIs) in patients undergoing colorectal surgery. If approved, the product would address a major unmet need in surgical care, where SSIs remain a significant cause of postoperative complications, hospital readmissions, and healthcare costs.
The NDA is supported by findings from the phase 3 SHIELD II trial, which met its primary endpoint and all key secondary endpoints. The study demonstrated a 60% relative reduction in surgical site infections compared with standard of care (p=0.0013). D-PLEX100 has also received FDA Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations, positioning it for potential Priority Review.
What You Need to Know
PolyPid has completed its NDA submission to the FDA for D-PLEX100, advancing the therapy toward a potential approval decision in the first quarter of 2027.
In the pivotal SHIELD II trial, D-PLEX100 reduced the risk of surgical site infections by 60% compared with standard care while meeting all primary and key secondary endpoints.
The therapy's localized, sustained-release doxycycline delivery system is designed to provide targeted infection prevention at the surgical site for up to 30 days with limited systemic exposure.
“Completing the NDA submission for D-PLEX100 is a defining milestone for PolyPid and the culmination of years of disciplined clinical and regulatory work,” PolyPid CEO Dikla Czaczkes Akselbrad, said in a statement. “With the full application now before the FDA, we are focused on supporting the agency’s review, finalizing our US commercial partnership discussions, and preparing for the potential approval and launch of a novel approach to the prevention of SSIs.”
D-PLEX100 utilizes PolyPid’s proprietary Kynatrix technology to deliver doxycycline directly at the surgical site during wound closure, providing controlled antibiotic release for approximately 30 days while minimizing systemic exposure. The FDA's target action date under the Prescription Drug User Fee Act (PDUFA) is currently anticipated in the first quarter of 2027.
