Business
PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
Following Positive Communication with the FDA, Regulatory Pathway Clarified for D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site Infections
About this update from Polypid Ltd.
[{"type":"text","content":"Following Positive Communication with the FDA, Regulatory Pathway Clarified for D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site Infections Company Expects to Resume Patient Recruitment in Q2 2023 into Ongoing SHIELD II Trial, which will be Enriched with Approximately 550 Additional Patients to Complete Clinical Testing for Potential NDA Top-line Results from SHIELD II Trial Anticipated mid-2024 Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Feb. 08, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three months and full year ended December 31, 2022. Recent Corporate Highlights: Clarified regulatory pathway toward a potential New Drug Application (NDA) submission for D-PLEX100 following a positive Type D meeting communication with the U.S. Food and Drug Administration (FDA) on the SHIELD I Phase 3 study data. FDA acknowledged that the SHIELD I results may provide supportive evidence in patients with large surgical incisions (>20 cm) and recommended that the Company conduct an additional study to support an NDA submission.FDA stated that the ongoing SHIELD II study could potentially serve as such study. SHIELD II patient recruitment is expected to resume in the second quarter of 2023 with the enrollment of an estimated 550 additional patients. Total recruitment time into the study is anticipated to be approximately 12 months and top-line results are expected mid-2024.Unblinded interim analysis is planned to be conducted once approximately 400 patients complete their 30-day follow-up. Announced publication of a post-hoc analysis of patients with one or more risk factors based on data from the previously completed Phase 2 study of D-PLEX100 for the prevention of SSIs in abdominal surgery in the American Journal of Surgery.Presented Phase 2 clinical data for D-PLEX100 at the first triennial International Orthopaedic Trauma Association meeting. “We are thrilled to now have a clear regulatory pathway to possible approval of D-PLEX100 in the U.S. following confirmation from the FDA that the ongoing SHIELD II trial can potentially be used to complete our clinical testing,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Execut...