PolyPid Completes Enrollment in Phase 3 Trial for Surgical Infection Prevention

PolyPid ( (PYPD) ) just unveiled an update.

PolyPid Ltd. announced the successful completion of patient enrollment in its Phase 3 SHIELD II trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries. Following a positive recommendation from the Data Safety Monitoring Board, the trial concluded with 800 patients enrolled. The company expects to report top-line results by the end of Q2 2025, and if positive, plans to submit a New Drug Application to the FDA, leveraging its Fast Track and Breakthrough Therapy designations. This milestone signifies a critical step in the development of D-PLEX100 and positions PolyPid for potential commercialization discussions in the U.S. and other regions.

More about PolyPid

PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. This technology enables the controlled, prolonged release of therapeutics, with their lead product candidate, D-PLEX100, currently in Phase 3 clinical trials for preventing abdominal colorectal surgical site infections. The company is also exploring the efficacy of OncoPLEX for treating solid tumors, starting with glioblastoma.

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