PolyPid Ltd. announced on March 11, 2025, the successful completion of enrollment in its SHIELD II Phase 3 trial for D-PLEX100. This milestone was achieved following a recommendation by the independent Data Safety Monitoring Board (DSMB) to conclude the study upon enrolling 800 patients.
The company anticipates reporting top-line results from the trial by the end of the second quarter of 2025. This completion marks a significant step towards the potential regulatory approval of D-PLEX100.
PolyPid is preparing to engage with the FDA for a pre-NDA meeting to discuss a rolling NDA submission under the Breakthrough Therapy designation. The company also remains in active discussions with multiple potential partners for the commercialization of D-PLEX100, particularly in the U.S. market.
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