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 Amir Weisberg, Chief Executive Officer of PolyPid. “The planned, unblinded interim analysis will strengthen the adaptive design of the study so that we can more precisely define the targeted patient enrollment range. It can also potentially allow for stopping the trial earlier than planned, if the efficacy results on SSIs are overwhelming.”

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.

About D-PLEX₁₀₀
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 U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX₁₀₀ has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.