PolyPid Ltd. (Nasdaq: PYPD) has announced the completion of patient enrollment for the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial of D-PLEX100. This trial is evaluating the efficacy of D-PLEX100 in preventing abdominal colorectal surgical site infections (SSIs). The outcome of the interim analysis is expected later this quarter.
The SHIELD II trial is a prospective, multinational, randomized, double-blind study designed to assess D-PLEX100 when administered with standard of care (SoC), compared to SoC alone, in preventing post-abdominal surgery incisional infections in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint measures the proportion of subjects with a surgical site infection (SSI) event, reintervention, or mortality within 30 days post-surgery.
SHIELD II Trial Details
The SHIELD II trial has enrolled over 540 patients to date, with 60 centers open across multiple countries, including Eastern Europe, the U.S., Germany, Ireland, Portugal, and Israel. Enrollment completion, with up to 630 patients, is expected in December 2024, and top-line results are anticipated in the first quarter of 2025. The unblinded interim analysis, triggered by the enrollment of 430 subjects and completion of their 30-day follow-up, will determine whether the trial concludes early due to positive efficacy, continues to planned patient recruitment, undergoes sample size re-assessment, or is stopped for futility.
D-PLEX100 and SHIELD I Results
D-PLEX100 is designed to provide local, prolonged, and controlled antibacterial activity at the surgical site to prevent SSIs. The PLEX (Polymer-Lipid Encapsulation matriX) technology enables a continuous release of doxycycline, a broad-spectrum antibiotic, resulting in a high local concentration of the drug for 30 days. The U.S. Food and Drug Administration granted D-PLEX100 Breakthrough Therapy Designation for SSI prevention in patients undergoing elective colorectal surgery.
Results from the Phase 3 SHIELD I trial, published in the International Journal of Surgery, showed a statistically significant reduction in the primary endpoint (a composite of incisional SSI, incisional reinterventions, or all-cause mortality) in D-PLEX100 treated patients with large surgical incisions (greater than 20 cm; p=0.0032). Analysis of the key secondary efficacy outcome, incisional SSI, also indicated a 54.6% reduction in the large surgical incision subgroup (4.4% in D-PLEX100 vs. 9.7% in standard of care (SoC), p= 0.0410).
Financial Position
PolyPid's CEO, Dikla Czaczkes Akselbrad, noted the significant acceleration in patient enrollment and the company's funding extending beyond this data catalyst. As of September 30, 2024, PolyPid had $9.5 million in cash, cash equivalents, and short-term deposits. The company anticipates that its current cash balance will fund operations into the first quarter of 2025, with potential funding into 2026 if all warrants from recent private placements are exercised.
