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PolyPid Granted Fast Track Designation from FDA for D-PLEX₁₀₀ for Prevention of Surgical Site Infections in Abdominal Surgery
PETAH TIKVA, Israel, Aug. 03, 2020 (GLOBE NEWSWIRE) -- 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, Aug. 03, 2020 (GLOBE NEWSWIRE) -- 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 D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention of post abdominal surgery incisional infections.\n The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious and life threatening conditions and fill an unmet medical need. Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process, and allows for a rolling review of a D-PLEX100’s New Drug Application (“NDA”). It also enables eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. “Receiving Fast Track designation from the FDA represents an important achievement for our promising D-PLEX100 development program,” said Amir Weisberg, PolyPid’s CEO. “We view the Fast Track designation as important regulatory validation of the novelty of our PLEX technology and the high clinical unmet need that currently exists in the ability to prevent surgical site infections in complex surgical settings such as abdominal surgeries. We recently initiated our SHIELD I Phase 3 clinical trial of D-PLEX100 for the prevention of post-abdominal surgery incisional infections, and look forward to the opportunity to provide a safe and effective solution for surgeons and their patients as quickly as possible.” About D-PLEX100 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 ...