PolyPid Unveils Phase 3 SHIELD II Trial Results for D-PLEX100

PolyPid to Showcase Promising Phase 3 SHIELD II Results
PETACH TIKVA, Israel — PolyPid Ltd. (Nasdaq: PYPD), a pioneering biopharma company focused on enhancing surgical outcomes, is thrilled to announce that Dr. Shmuel Sharoni will present the positive topline results of the Company's Phase 3 SHIELD II trial of D-PLEX???. This significant event will take place at the upcoming American College of Surgeons (ACS) Clinical Congress.
Overview of the Presentation
Dr. Sharoni's presentation, titled "Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The SHIELD II Phase 3 Randomized Clinical Trial," is scheduled for a high-impact session on a specified date. This session promises to provide insights into how D-PLEX??? can vastly improve patient care.
Conference Details for Attendees
The 2025 ACS Clinical Congress will be hosted at McCormick Place and will run from October 4 to October 7. Dr. Sharoni's engaging presentation is set for October 5 at 11:30 AM CT as part of the "High Impact Clinical Trials and Studies" session. This is an excellent opportunity for healthcare professionals and stakeholders in the surgical field to learn about groundbreaking advances in infection prophylaxis.
Meet the PolyPid Team
The PolyPid management team invites attendees to connect for discussions and inquiries regarding their recent findings and future plans. Reach out via the designated email for questions or to arrange a meeting during this prominent event.
Introducing the SHIELD II Trial
The SHIELD II trial was a well-structured, multinational study designed to gauge the effectiveness of D-PLEX??? in a controlled, randomized fashion. This double-blind study marked a significant milestone by successfully meeting its primary and secondary efficacy endpoints. The findings revealed a remarkable 38% reduction in surgical site infections, as well as reinterventions or mortality risk when D-PLEX??? was used alongside standard care. Specifically, this trial reported a striking 58% reduction in surgical site infections attributable to D-PLEX???.
About PolyPid Ltd.
PolyPid Ltd. operates at the forefront of biopharma innovation (Nasdaq: PYPD). The Company aims to transform surgical care through prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. This technology facilitates precise and controlled drug delivery, ensuring effective treatment over extended periods. Following the encouraging results from the Phase 3 trial, PolyPid plans to pursue a New Drug Application (NDA) for D-PLEX??? in early 2026, reinforcing their commitment to addressing infection risks in colorectal surgeries. Furthermore, PolyPid is developing solutions across diverse medical challenges including oncology, obesity, and diabetes.
Additional Information
If you would like to learn more about PolyPid and its initiatives, please visit their official website or connect with them on social media platforms for the latest updates.
Frequently Asked Questions
What is the Phase 3 SHIELD II trial about?
The SHIELD II trial evaluates the efficacy of D-PLEX??? in reducing surgical site infections in colorectal surgeries.
When will the trial results be presented?
The topline results will be presented at the ACS Clinical Congress on October 5, 2025.
How effective was D-PLEX??? compared to standard care?
D-PLEX??? demonstrated a 38% reduction in surgical site infections, reinterventions, or mortality compared to standard care.
What is the next step for PolyPid following the trial results?
PolyPid plans to submit a New Drug Application (NDA) for D-PLEX??? in early 2026 based on the positive trial outcomes.
What other applications is PolyPid exploring?
In addition to surgical care, PolyPid is developing innovative solutions in oncology, obesity, and diabetes.
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