PolyPid Announces Receipt of Qualified Infectious Disease Product (QIDP) Designation from FDA for D-PLEX100 in Post-Cardiac Surgery Sternal Infection
QIDP Designation Allows for FDA Priority Review and Adds Five Years of Market Exclusivity for D-PLEX™.
D-PLEX™ Currently Subject of On-going Phase Ib/II Study in Israel.
Company Intends to Seek Regulatory Approvals in U.S. and Europe in Coming Year to Conduct Phase III Clinical Trial of D-PLEX™.
Petah Tikva, Israel, March 08, 2017 — PolyPid Ltd., an emerging clinical-stage specialty pharmaceutical company focused primarily on the development of a post-surgical anti-infective pipeline, announced today that the Company’s lead product candidate, D-PLEX™ (Doxycycline/Polymer-Lipid Encapsulation Matrix), a secured antibiotic drug reservoir that provides a safe and effective local anti-bacterial prevention and treatment measure during surgical procedures, has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food & Drug Administration (FDA).
Under the FDA’s QIDP program, which is designed to speed the development of novel drugs against important pathogens, PolyPid will be able to take advantage of certain incentives, including FDA priority review, eligibility for fast-track status and an additional five-years of market exclusivity when marketing approval is granted for D-PLEX™ in preventing post-cardiac surgery sternal infection.
Post-cardiac surgery sternal infection is an unmet medical need and one of the most significant complications following open cardiac surgery, which according to known literature carries has a mortality rate reaching 40%.
“The receipt of QIDP designation from the FDA represents an important milestone that expedites and extends the commercial path for D-PLEX™ in the U.S.,“ said Amir Weisberg, PolyPid’s Chief Executive Officer. “We view this QIDP designation as validation of the significant potential of D-PLEX™ in preventing and treating surgical site infections. We look forward to the availability of additional data by year-end 2017 from our ongoing Phase Ib/II study in Israel of D-PLEX™ in post-cardiac surgery sternal infection.”
Initial data from the ongoing Phase Ib/II study of D-PLEX™ in Israel showed no sternal infection occurred during three-month follow-up in the treated patients. Moreover, D-PLEX™ was safe and there were no adverse events related to the product.
PolyPid intends to seek regulatory approvals in the U.S. and Europe in the coming year to conduct a Phase III trial of D-PLEX™ in post-cardiac surgery sternal infection. The Company recently completed a successful pre-Investigational New Drug Application meeting with the FDA in which the Agency agreed that D-PLEX™ can move directly into a Phase III trial in the U.S., based on the phase Ib/II satisfactory results. In addition, the FDA agreed that D-PLEX™ would be reviewed under the 505(b)(2) approval pathway.
PolyPid’s lead product, D-PLEX™, is a secure antibiotic drug reservoir that provides a safe and effective local anti-bacterial preventive and treatment at the target site and is designed to be administered during surgical procedures. After surgery, the drug reservoir constantly releases the entrapped antibiotic over several weeks, thus allowing prolonged infection management with increased potential to eradicate antibiotic resistant bacteria.
PolyPid is a clinical stage, emerging specialty pharmaceutical company, developing, manufacturing and commercializing products based on a proprietary platform, PLEX™ (Polymer-Lipid Encapsulation matriX), in the field of extended release, local drug delivery. PLEX™ technology optimizes drug therapeutic performance and clinical outcomes, improves pharmacoeconomic potential and offers lifecycle extension for novel drugs. This is achieved via protected drug reservoirs enabling prolonged delivery of drugs, including biologics, over periods ranging from days to several months. The application of PLEX™ technology enables optimized drug treatment regimens by predetermining release rates and durations, a rare combination of attributes. PLEX™-based products have demonstrated an excellent safety profile during extended clinical studies, with over 65 patients exposed to the technology to date. PolyPid’s technology and products are based on the inventions of Dr. Noam Emanuel, the founder and the chief technology officer of the company.
For additional company information, visit www.polypid.com.
Dikla Czaczkes Akselbrad
Chief Financial Officer