PolyPid Ltd. announced that the United States Food and Drug Administration (FDA) has granted a second Qualified Infectious Disease Product (QIDP) designation to D-PLEX100 for the prevention of post-abdominal surgery incisional infection.
- QIDP designation provides additional five years of market exclusivity and eligibility for FDA priority review and Fast Track designation
- A Phase II clinical study in abdominal surgery is currently ongoing with more than 140 patients already enrolled, top-line results are expected in the second half of 2019
PETAH TIKVA, Israel, May 21, 2019 PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies, announced today that the United States Food and Drug Administration (FDA) has granted a second Qualified Infectious Disease Product (QIDP) designation to D-PLEX100 for the prevention of post-abdominal surgery incisional infection.
D-PLEX100, PolyPid’s lead product candidate, had previously received both QIDP designation and Fast Track status from the FDA for the prevention of sternal wound infection post cardiac surgery, one of the most devastating complications with a mortality rate of up to 40 percent when deep sternal infection occurs. Plans are currently underway for PolyPid to commence their Phase 3 clinical trial in cardiac surgery in the second half of 2019.
“This additional QIDP designation for D-PLEX100 in abdominal surgery expands significantly the potential surgical population that may benefit from D-PLEX100,” said Amir Weisberg, PolyPid’s Chief Executive Officer. “Abdominal surgeries, and especially those involving colorectal resection are notorious for their high rates of surgical site infections (SSIs), and the need for preventive solutions is acute. At this time, we remain focused on completing the Phase 2 study of D-PLEX100 in abdominal surgery for which we plan to report top-line results in the second half of this year”
About D-PLEX100
PolyPid’s lead drug product candidate, D-PLEX100, is a novel product designed to provide local and prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables the prolonged and constant release of high local concentration of broad-spectrum antibiotic for a period of four weeks, thus allowing effective prevention of infection after surgery with increased potential to eradicate antibiotic resistant bacteria.
About PolyPid
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. PolyPid’s technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
For additional company information, visit www.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.
Company contact:
PolyPid, Ltd.
Dikla Czaczkes Akselbrad
Chief Financial Officer
Tel: +972-747195700
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SOURCE Polypid Ltd.
