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 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).
"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."
"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."
SHIELD 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 with at least one abdominal target incisional infection event within 30 days post abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in approximately 50 centers in the United States, Europe and Israel.
PolyPid's lead product candidate, D-PLEX100 , is a novel product candidate designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention of post-abdominal surgery incisional infection.
PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
For additional company information, visit www.polypid.com.
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Dikla Czaczkes Akselbrad
EVP & CFO
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