PolyPid announces receipt of Qualified Infectious Disease Product (QIDP) designation from FDA for D-PLEX in post-cardiac surgery sternal infection.
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 percent.
“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.
(Source: PR Newswire)
