PolyPid Reaches 200 Patient Enrollment in SHIELD II Trial for D-PLEX100 in Abdominal Surgery

PolyPid Ltd., a biopharmaceutical company in its late stages of development, has achieved a significant milestone by enrolling its 200th patient in the SHIELD II Phase 3 clinical trial for D-PLEX100. This trial aims to prevent surgical site infections (SSIs) in patients undergoing major abdominal colorectal surgeries. The study is now about one-third complete and is enrolling patients at a rate of approximately 1.5 per center each month. Currently, around 40 centers are active in the trial, and the company plans to add about 20 additional centers in the coming months.

An interim analysis of the study data will take place in mid-2024, once around 400 patients have finished their 30-day follow-up. This phase is crucial for understanding the potential effectiveness and safety of D-PLEX100. Top-line results from the study are anticipated to be available in the latter half of 2024.

Dikla Czaczkes Akselbrad, CEO of PolyPid, noted that patient enrollment has significantly increased over the last two months and the study is continuing at a steady, robust pace. Moreover, a $16 million financing round completed earlier in the year ensures the company's financial stability through the planned interim analysis. Depending on the positive outcomes of this analysis, there is an additional potential funding of $19 million, which could support the company through to the initiation of a rolling New Drug Application (NDA) submission for D-PLEX100.

Earlier in 2024, PolyPid secured $16 million through a private financing round involving both new and existing investors, including significant participation from U.S.-based life sciences investors DAFNA Capital Management and Rosalind Advisors. This funding effort positions the company to potentially gather an additional $19 million if the interim results are favorable and warrants are exercised, crucially supporting the timeline for the anticipated NDA submission.

The SHIELD II trial is a global, randomized, double-blind Phase 3 study assessing D-PLEX100's efficacy and safety, combined with standard care versus standard care alone. The primary measure of effectiveness includes the proportion of patients experiencing SSIs, needing reintervention, or mortality from any cause within 30 days post-surgery. The study includes centers in the U.S., Europe, and Israel, with patient safety monitored for 30 additional days.

D-PLEX100 is designed to offer localized, prolonged, and controlled antibacterial action at the surgical site, primarily preventing SSIs. Utilizing PolyPid's PLEX technology, it delivers doxycycline, a broad-spectrum antibiotic, ensuring high local concentration over 30 days. This method not only targets standard infections but also those caused by antibiotic-resistant bacteria. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. FDA for preventing SSIs in elective colorectal surgeries and is currently in Phase 3 trials.

PolyPid is focused on enhancing surgical outcomes via controlled, prolonged-release medications, using proprietary PLEX technology to ensure precise drug delivery. Beyond D-PLEX100 for SSI prevention in abdominal colorectal surgeries, the company is also in preclinical stages of testing OncoPLEX for solid tumors treatment, starting with glioblastoma.