PolyPid Announces 750th Patient Enrolled in SHIELD I Phase 3 Clinical Trial of D-PLEX₁₀₀ in Abdominal Surgery
“We are very pleased with the recent high rate of enrollment in SHIELD I, especially considering the recent disruption to hospitals caused by the surge of COVID-19 infections driven by the Omicron variant,” stated
The FDA has previously agreed, provided the Phase 3 study results are adequate, that a single pivotal study is sufficient for potential approval of D-PLEX100 for the prevention of SSIs in colorectal (abdominal) surgery.
PolyPid’s lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled 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 continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the
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Dikla Czaczkes Akselbrad
EVP & CFO
Source: PolyPid Ltd.