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PolyPid Initiates First Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Post-Abdominal Surgery Incisional Infections
PETAH TIKVA, Israel, July 1, 2020 /PRNewswire/ -- PolyPid Ltd. (Nasdaq: PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing
About this update from Polypid Ltd.
[{"type":"text","content":"PETAH TIKVA, Israel, July 1, 2020 /PRNewswire/ -- PolyPid Ltd. (Nasdaq: PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that the first patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's first of two Phase 3 clinical trials of its lead product candidate D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).\n\"We are very pleased with the initiation of our SHIELD I trial, one month after the submission of an amendment to our Investigational New Drug application to the U.S. Food and Drug Administration (FDA) on May 29, 2020 \" said Amir Weisberg, PolyPid's CEO. \"Enrollment of the first patient in this trial represents a significant milestone for our D-PLEX100 development program. Abdominal surgery is the second surgical model to enter Phase 3 development for D-PLEX100. We believe that this trial, combined with the second Phase 3 clinical trial in this indication that is planned to start approximately 6 months from now, represents a key advancement toward our U.S. regulatory approval strategy and our ability to provide a novel solution for surgeons and their patients as expeditiously as possible.\"\n\"D-PLEX100 has shown promise in a previous Phase 2 clinical trial by significantly decreasing surgical site infections (SSI) in abdominal surgery with colorectal resection, one of the most complex surgical setting for SSIs\" said Dr. Anthony Senagore, colorectal surgeon and a medical advisor to PolyPid. \"The need for additional preventive solutions is acute, especially with the emergence of antibiotic resistant bacteria, and so we look forward to evaluating D-PLEX100 in the SHIELD-I trial as a potential solution for our surgical patients.\"\nSHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects ...