PolyPid Announces 750th Patient Enrolled in SHIELD I Phase 3 Clinical Trial of D-PLEX??? in Abdominal Surgery
PolyPid Ltd a Phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, announced today that the 750th patient has been enrolled into its ongoing pivotal Phase 3 SHIELD I study evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. Upon completion of the 30-day follow-up assessment for the 750th patient, based on an agreement with the U.S. Food and Drug Administration (FDA), an unblinded interim analysis will be conducted. This interim analysis is expected to occur during the second quarter of this year, and will allow for early trial conclusion due to efficacy, futility, or for sample size re-assessment.
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