PolyPid Ltd. has recruited the first patient in its revised SHIELD II Phase 3 trial for D-PLEX100, a late-stage biopharma product aimed at preventing abdominal colorectal surgical site infections. The US Food and Drug Administration recently accepted the company’s revised protocol for the study, which will enroll an estimated 550 patients undergoing colorectal resection surgery with large incisions over 20cm. PolyPid aims to conduct an unblinded interim analysis once around 400 patients have completed their follow-up.
PolyPid's PLEX technology is designed to pair with Active Pharmaceutical Ingredients (APIs) through locally administered, controlled, prolonged-release therapeutics. Its lead product candidate, D-PLEX100, is in a Phase 3 clinical trial for prevention of abdominal colorectal surgical site infections. The company is also testing OncoPLEX in preclinical stages for treatment of solid tumors such as glioblastoma.
PolyPid CEO Dikla Czaczkes stated that the recruitment of the first patient in the revised SHIELD II trial represents a significant milestone for their promising late-stage D-PLEX100 development program