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PolyPid Ltd. (Nasdaq: PYPD) is a cutting-edge biopharmaceutical company focused on enhancing surgical outcomes through its innovative drug delivery technology, PLEX™ (Polymer-Lipid Encapsulation matriX). This proprietary technology allows for the precise, prolonged release of drugs directly at the target site, optimizing therapeutic performance and clinical outcomes. PolyPid specializes in the development and manufacturing of products that address unmet medical needs, particularly in the prevention of surgical site infections (SSIs) and treatment of solid tumors.
The company's lead product candidate, D-PLEX100, is designed to provide localized, controlled anti-bacterial activity at surgical sites to prevent SSIs. It is currently undergoing a Phase 3 clinical trial, known as SHIELD II, aimed at preventing infections in patients undergoing open abdominal colorectal surgery. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential to address significant medical needs.
PolyPid's product pipeline also includes OncoPLEX, intended for the treatment of solid tumors, beginning with glioblastoma. This product is currently in preclinical stages, showing promising potential in oncology. Additionally, the company's proprietary technology, PLEX™, can encapsulate various drugs, enabling targeted and localized delivery over extended periods, ranging from several days to months.
In terms of recent achievements, PolyPid has successfully enrolled and randomized over 200 patients in its SHIELD II trial, with top-line results expected in the second half of 2024. Moreover, the company recently closed a $16 million private placement financing, which will support ongoing clinical development efforts and extend its cash runway beyond the anticipated interim analysis of the SHIELD II trial.
For more detailed information, visit PolyPid's official website or follow the company on Twitter and LinkedIn.
PolyPid, a biopharma company, hosted a Key Opinion Leader event to address the increasing rates of Surgical Site Infections (SSIs) post-COVID and provided an update on its SHIELD II Phase 3 trial for D-PLEX100. The event highlighted the rising SSI rates, the significant cost to payers, and the potential of D-PLEX100 to reduce SSIs in colorectal surgeries. Approximately 250 of the planned 600 patients are enrolled in the SHIELD II trial, with unblinded interim analysis expected once 400 patients complete their 30-day follow-up. Top-line results are anticipated in Q1 2025.
PolyPid announced a virtual Key Opinion Leader (KOL) event on June 17, 2024, at 10:00 AM ET to discuss the unmet medical need in surgical site infections (SSIs). Charles E. Edmiston, Ph.D., an Emeritus Professor of Surgery at the Medical College of Wisconsin, will highlight the clinical and economic burden of SSIs and current practices for their prevention. The event will also provide an update on PolyPid's Phase 3 SHIELD II trial for D-PLEX100, a product aimed at preventing abdominal colorectal SSIs. During the event, PolyPid management will update on patient enrollment status. A live Q&A session with Professor Edmiston and the management team will follow.
PolyPid provided a corporate update and reported financial results for the first quarter of 2024. The company enrolled over 200 patients in the SHIELD II Phase 3 trial for D-PLEX100 to prevent abdominal colorectal surgical site infections. The unblinded interim analysis is expected to be conducted after around 400 patients complete their 30-day follow-up, with top-line results anticipated in the second half of 2024. Additionally, PolyPid closed a private placement financing for $16 million, extending its cash runway beyond the planned analysis.
PolyPid (Nasdaq: PYPD) will participate in the Citizens JMP Life Sciences Conference in New York to present their late-stage biopharma innovations aimed at enhancing surgical outcomes. The event will be held from May 13 – 14, 2024, with a management presentation scheduled for May 13 at 2:30 PM ET.
PolyPid announced the enrollment of the 200th patient in the SHIELD II Phase 3 trial for D-PLEX100 to prevent surgical site infections. The study is one-third enrolled with top-line results expected in the second half of 2024. The company completed a $16 million financing and has the potential to secure an additional $19 million based on positive interim analysis results.
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