PolyPid Announces FDA Clearance of Investigational New Drug Application (IND) to Commence Pivotal Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Sternal Wound Infection Post-Cardiac Surgery
Multinational Phase 3 study expected to start in the first half of 2019
Petah Tikva, Israel — November 12, 2018 – – PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies for post-surgical complications, announced today that the United States Food and Drug Administration (FDA) has completed its review of the IND and indicated that PolyPid may proceed with its phase 3 clinical trial of its lead asset D-PLEX100 for the prevention of post-cardiac surgery sternal Infections. The study is a prospective, multinational, multicenter, randomized, single blind, study to assess the efficacy and safety of D-PLEX100 in prevention of post-cardiac surgery sternal infections. The clinical trial is expected to start in the first half of 2019.
“The IND clearance of our Pivotal Phase 3 clinical trial by the FDA is a very important regulatory milestone for the company and our lead D-PLEX100 program,” said Dalit Hazan, Vice President Regulatory Affairs of PolyPid. “Together with the Qualified Infectious Disease Product (QIDP) designation received in February 2017, it further validates our clinical and regulatory strategy for entering the U.S. market.”
PolyPid’s lead product candidate, D-PLEX100, is a novel product designed to provide local anti-bacterial activity directly at the surgical site to prevent surgical site infections. Following D-PLEX100 administration into the surgical site, the drug reservoir constantly releases the entrapped broad-spectrum antibiotic in a controlled manner over a predetermined period of four weeks, thus allowing prolonged infection management with increased potential to eradicate antibiotic resistant bacteria.
PolyPid is a clinical stage, biopharmaceutical company focused on developing and commercializing novel, locally administered therapies using its transformational PLEX (Polymer-Lipid Encapsulation Matrix) technology to treat a wide variety of localized medical conditions with an initial focus on the management of surgical site infections. PLEX-based products have demonstrated an excellent efficacy and safety profile during extended clinical trials, with more than 100 patients treated in clinical trials to date.
For additional company information, visit polypid.com.
Forward looking Statement
This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995.
Dikla Czaczkes Akselbrad
Chief Financial Officer