PolyPid Ltd. announced the successful completion of the production of three process validation batches of D-PLEX100 which have started stability program. This successful production process validation completes a substantial requirement toward the Company?s planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings. 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 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.