PolyPid completes enrollment in phase 3 SHIELD II trial of D-PLEX100 for prevention of abdominal colorectal surgical site infections

PolyPid Ltd., a late-stage biopharma company aiming to improve surgical outcomes, announced the successful completion of enrollment in the SHIELD II phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the independent Data Safety Monitoring Board (DSMB), which, after analyzing unblinded efficacy data from the first 430 enrolled patients in the trial, recommended concluding the study upon enrollment of 800 patients, the lowest sample size reassessment stop after the minimum planned number of patients.

The company anticipates reporting top-line results by the end of the second quarter of 2025. If the phase 3 data are positive, PolyPid expects to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA), leveraging the FDA’s Fast Track and Breakthrough Therapy designations.

“We are excited to reach another critical milestone in our ongoing SHIELD II phase 3 trial, reinforcing the positive trajectory of D-PLEX100’s development,” said Dikla Czaczkes Akselbrad, PolyPid’s chief executive officer. “With top-line data expected by the end of the second quarter of 2025, we are preparing to engage with the FDA for a pre-NDA meeting to discuss a rolling NDA submission under the Breakthrough Therapy designation. Importantly, we remain in active discussions with multiple potential partners for the commercialization of D-PLEX100 in various regions, starting with the US.”

SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (SSI) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.

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, Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of SSIs in patients undergoing abdominal colorectal surgery. D-PLEX100 is currently in phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.

PolyPid Ltd. is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months.