Enrollment of 100th Patient in SHIELD II Phase 3 Trial for D-PLEX100

PolyPid Ltd., a biopharmaceutical firm dedicated to enhancing surgical outcomes, has recently achieved a significant milestone in its SHIELD II Phase 3 clinical trial. The 100th patient has been enrolled and randomized in the study, which is designed to evaluate the efficacy of D-PLEX100 in preventing surgical site infections for patients undergoing abdominal colorectal surgery with sizable incisions. Approximately 40 centers are currently participating in this trial.

The trial's primary endpoint is to assess the rate of patients experiencing surgical site infections within 30 days post-surgery, alongside other related measures. An interim analysis is planned once around 400 patients have completed their 30-day follow-up, anticipated to occur in mid-2024. The company's CEO, Dikla Czaczkes Akselbrad, has expressed confidence in the progress made and the expected results in the latter half of 2024.

Financially, PolyPid has bolstered its resources with a successful private placement financing round, raising $16 million. This capital injection extends the company's operational runway into late Q3 2024 and potentially further, should additional funds be raised through warrant exercises. The funds will support the company through the upcoming interim analysis and towards the submission of a New Drug Application for D-PLEX100.

D-PLEX100, PolyPid's leading product candidate, utilizes the company's proprietary PLEX technology to deliver a sustained release of the antibiotic doxycycline directly at the surgical site. This approach aims to provide a high concentration of the drug over an extended period, offering protection against both common and antibiotic-resistant bacteria. The product has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and is currently in Phase 3 trials.

PolyPid's innovative PLEX technology is also being explored for other applications, such as the treatment of solid tumors, with OncoPLEX currently in preclinical development.

The company's focus on local administration and controlled release of therapeutics is poised to make a significant impact on surgical outcomes and patient recovery. With the ongoing SHIELD II trial and the financial support secured, PolyPid is well-positioned to advance its mission to improve patient care through innovative pharmaceutical solutions.