Nano-Cap PolyPid's Lead Drug Candidate Cuts Surgical Infection Risk by 38% In Phase 3 Trial

Zinger Key Points

D-PLEX100 plus SoC reduced infection or death by 38% vs. SoC alone (10.9% vs. 18.1%; p<0.005).
Deep and superficial SSI rates dropped by 58% with D-PLEX100 plus SoC (3.8% vs. 9.5%; p<0.005).
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PolyPid Ltd. PYPD on Monday announced topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions.

The SHIELD II trial is designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the standard of care (SoC), which includes prophylactic systemic antibiotics, compared to the SoC alone arm in the prevention of post-abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions.

The trial’s primary endpoint is measured by the proportion of subjects with a surgical site infection or mortality for any reason within 30 days post-surgery.

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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 antibacterial 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 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site.

The trial met the primary efficacy endpoint, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC (n=405; 10.9%), compared to SoC alone (n=393; 18.1%), representing a 38% reduction (p<0.005).

SHIELD II included three key secondary endpoints:

The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC (3.8%) compared to those who received SoC alone (9.5%) (p<0.005).
The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone (p<0.005).
The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS1 score >20 in the D-PLEX100 plus SoC arm compared to the SoC alone arm (p<0.05). The ASEPSIS score is a clinical tool used to assess surgical wound infections objectively.

The independent Data Safety Monitoring Board raised no safety concerns in SHIELD II.

The company expects to submit a New Drug Application to the U.S. Food and Drug Administration in early 2026, with a Marketing Authorization Application in the E.U. to follow shortly thereafter.

Price Action: PYPD stock is trading higher by 12% to $3.66 at last check Monday.

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