PolyPid Provides Positive Regulatory Update for D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Colorectal Surgery
• Regulatory Pathway for a Potential NDA Submission Clarified Following Recent Interactions with the FDA
• FDA Acknowledged that SHIELD I Pre-specified Subgroup Results May Provide Supportive Evidence and Proposed that Current SHIELD II Trial Could Potentially Serve to Complete Clinical Testing for NDA
• FDA Also Recognized that D-PLEX100’s Proposed Indication is for the Prevention of Infection and Has the Potential for Wide Use
PETACH TIKVA, Israel, Jan. 24, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). Following a recent type D meeting communication with the U.S. Food and Drug Administration (FDA) on the SHIELD I Phase 3 data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission.
PolyPid provided to the FDA currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. Based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD II study, which to date has enrolled over 200 patients, could potentially serve as such a study. PolyPid is now working expeditiously to finalize the design of the revised SHIELD II trial and expects to resume patient recruitment next quarter.
“We are pleased with the outcome of our recent interactions with the FDA and are grateful to the Agency for their supportive feedback,” stated Ms. Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “We now have a clear regulatory pathway for the possible approval of D-PLEX100 in United States, and we remain highly confident in the potential of our promising late-stage product candidate. We are focused on evaluating the most appropriate measures to implement the FDA’s recommendations and are also preparing for near-term interactions with the EU regulatory authorities regarding D-PLEX100. We look forward to providing further clinical and regulatory updates on both U.S. and European markets.”
References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.
Future Proofing Your Marketing Strategy
Keynote Presentation by LTIMindtree: Getting to the Future, Faster with a Connected Universe
IoT Video: Seeing is Believing