Business
PolyPid Announces Successful Completion of Manufacturing Process Validation for D-PLEX₁₀₀
Company has Successfully Completed the Production of Three Process Validation Batches at Commercial Scale Completes a Substantial Requirement Toward the
About this update from Polypid Ltd.
[{"type":"text","content":"Company has Successfully Completed the Production of Three Process Validation Batches at Commercial Scale Completes a Substantial Requirement Toward the Planned Submission of D-PLEX100 NDA and MAA Regulatory Filings PETACH TIKVA, Israel, Sept. 19, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of the production of three process validation batches of D-PLEX100 which have started stability program. This successful production process validation completes a substantial requirement toward the Company’s planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings. “The successful validation of the production process at commercial scale is the result of a significant facility expansion and scale-up that more than tripled the Company’s capacity to manufacture D-PLEX100 for the U.S., EU and global markets,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Our in-house state-of-the-art GMP sterile production facility provides us with full control of D-PLEX100 manufacturing from clinical stage to commercial supply and serves as a key competitive advantage going forward. Importantly, we have now evolved into a fully-integrated biopharmaceutical company.” PolyPid’s ongoing Phase 3 SHIELD II trial of D-PLEX100 for the prevention of surgical site infections (SSIs) is currently recruiting patients undergoing open abdominal colorectal surgery with large incisions. Top-line results are expected in mid-2024. About D-PLEX100 D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and ...