PolyPid (NASDAQ: PYPD) is nearing completion of its SHIELD II pivotal trial for D-PLEX100, designed to prevent surgical site infections (SSIs) following colorectal surgeries. The company anticipates full enrollment of approximately 630 subjects by December 2024, with about 550 subjects already enrolled across multiple centers in Eastern Europe, the U.S., Germany, Ireland, Portugal, and Israel. An unblinded interim analysis is expected this quarter, which could lead to early trial conclusion based on positive efficacy, continuation to planned patient recruitment, sample size reassessment, or futility.
The SHIELD II trial is focused on a patient population similar to that of the SHIELD I trial, where D-PLEX100 demonstrated statistically significant results in a pre-specified analysis of patients with surgical incisions greater than 20 centimeters (p < 0.01). In this subgroup, D-PLEX100-treated patients showed significant improvements in the primary endpoint, a combination of incisional SSI, incisional reinterventions, or all-cause mortality. A key secondary efficacy outcome, incisional SSI, also showed a statistically significant reduction (p < 0.05).
Financial Status and Outlook
PolyPid reported a cash position of $9.5 million as of September 30, 2024, expected to fund operations into early 2025. The company has the potential to secure an additional $24.6 million through private placement financing, dependent on the SHIELD II trial's interim analysis results and warrant exercises. Research and development expenses increased to $6 million for the quarter due to heightened trial activity, contributing to a net loss of $7.8 million.
Strategic Plans
PolyPid anticipates establishing a strategic partnership for the U.S. commercialization of D-PLEX100. The company also sees potential market expansion into South America and Asia. Contingent on SHIELD II trial outcomes, PolyPid plans to submit a New Drug Application (NDA) by 2026.
SHIELD I Trial Publication
The full data set from the SHIELD I trial was recently published in the International Journal of Surgery. The publication highlighted compelling data from a pre-specified analysis of patients with surgical incisions greater than 20 centimeters, where D-PLEX100 demonstrated significant improvements in the primary endpoint (p < 0.01) and a statistically significant reduction in incisional SSI (p < 0.05).
Rising Infection Rates
A recent CDC report indicated a 3% increase in surgical site infections (SSI) overall and an 8% increase in SSI following hysterectomies, suggesting a rise in infection rates post-COVID-19. Dikla Czaczkes Akselbrad, CEO of PolyPid, noted that this trend supports the need for D-PLEX100.
Interim Analysis Criteria
The interim analysis of the SHIELD II trial requires a p-value of 0.01 or lower for efficacy. Data from the SHIELD I trial in high-risk patients with long incisions showed a p-value of 0.0032 and an overall effect of 54%, providing a benchmark for the potential impact of D-PLEX100.
Commercialization Strategy
PolyPid is actively engaging in discussions regarding the commercialization of D-PLEX100, with a focus on U.S. and global partnerships. The company believes that D-PLEX100 has the potential to significantly improve surgical outcomes and reduce the burden of surgical site infections.
