PolyPid Ltd. announced the publication of positive preclinical results demonstrating, for the first time, the safety profile of D-PLEX100 and the PLEX technology platform in juvenile animals. These preclinical data were published in the peer-reviewed journal, International Journal of Toxicology, in a paper titled, ?Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine,? which can be found here.

The safety and toxicokinetics of D-PLEX100 were tested following its administration via an abdominal incision to juvenile swine. The animals were evaluated for a period of nine months and no treatment-related adverse events were observed during this period. PolyPid?s ongoing Phase 3 SHIELD II trial of D-PLEX100 for the prevention of surgical site infections (SSIs) is currently recruiting patients undergoing open abdominal colorectal surgery with large incisions.

Top-line results are expected in mid-2024. D-PLEX100, PolyPid?s lead product candidate, is 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 (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site.

D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing open abdominal colorectal surgery with large incisions.