PolyPid Announces Recommendation by Data Safety Monitoring Board to Conclude Enrollment of Phase 3 SHIELD I Trial of D-PLEX₁₀₀ at the Minimum Number of Patients Targeted Following Unblinded Interim Efficacy Analysis
| Source: PolyPid Ltd.
PETACH TIKVA, Israel, May 23, 2022 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today that following the independent Data Safety Monitoring Board (DSMB) review of unblinded efficacy data from the first 750 enrolled patients in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal tissue surgery, the recommendation was to conclude the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol. The enrollment of the 950th patient is expected to occur within days.
The SHIELD I study is designed to demonstrate at least a 50 percent reduction in incisional SSIs in the D-PLEX100 treatment arm compared to the control arm, with 90 percent power and a maximum alpha level of 0.04.
The Company anticipates reporting top-line results by the end of the third quarter of 2022, followed by a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and a European Union Marketing Authorization Application (MAA) filing, both targeted for the first half of 2023.
“We are pleased with the DSMB recommendation and expect to conclude the SHIELD I trial shortly,” stated Amir Weisberg, PolyPid’s CEO. “SSIs represent a major unmet medical need and a large commercial opportunity for D-PLEX100. We look forward to completing the SHIELD I study and advancing preparations for our planned NDA submission and pre-launch activities, while expediting partnership discussions in and outside of the United States.”
“D-PLEX100, if approved, could significantly alter the surgical landscape, where postoperative infections remain a costly problem,” stated Dr. Kyle Cologne, Associate Professor of Colorectal Surgery, University of Southern California, who serves as an advisor to PolyPid. “SSIs are among the most prevalent complications following surgery, occurring in 6-26 percent of patients undergoing abdominal surgeries, particularly after open colorectal resection. Currently, the lack of effective infection prevention methods exposes patients to higher risk. When they occur, SSIs lead to hospital readmission, increased resource utilization and cost the U.S. healthcare system nearly $10 billion annually. The opportunity to make significant inroads to reduce these numbers is an exciting possibility with D-PLEX100.”