PolyPid Completes Enrollment in Phase Ib/II Study of D-PLEX

PolyPid Ltd. recently announced the completion of enrollment in its Phase Ib/II study of D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix), the company’s lead product candidate, for the prevention of post-cardiac surgery sternal infection. D-PLEX is a secured antibiotic drug reservoir that provides a safe and effective local anti-bacterial prevention and treatment measure during surgical procedures.

Sternal infection following cardiac surgery is an unmet medical need and one of the most significant complications following open cardiac surgery, which, according to known literature, has a mortality rate of up to 40%.

The Phase Ib/II study of D-PLEX is a prospective, multi-center, two-part trial evaluating the safety and efficacy of D-PLEX in the prevention of sternal infection post-cardiac surgery. The study is being conducted in Israel on a total of 80 patients. PolyPid expects first line data on all patients in this trial to be available by the end of 2017. The company intends to seek regulatory approvals in the US and Europe in 2018 to conduct a Phase III trial of D-PLEX in prevention of post-cardiac surgery sternal infection.

To date, PolyPid has treated more than 100 patients with its PLEX based anti-infective products. Preliminary data from studies in orthopedic indications showed no infections in the treated organ. Moreover, D-PLEX was safe with no adverse events related to the product.

“The completion of enrollment in our Phase Ib/II study for our lead product candidate, D-PLEX, represents a key accomplishment for our company,” said Amir Weisberg, PolyPid’s Chief Executive Officer.

“Based on the data generated to date, including its potential effectiveness against resistant bacteria, we believe D-PLEX has the potential to be a safe and effective treatment for the prevention of post-cardiac surgery sternal infection, as well as in other surgical indications. We look forward to the availability of data from all patients in this study by the end of the year, as well as initiating a Phase III clinical trial of D-PLEX in 2018,” added Dr. Noam Emanuel PolyPid’s Chief Technology Officer.

PolyPid previously completed a successful pre-Investigational New Drug Application meeting with the US FDA in which the FDA agreed that D-PLEX can move directly into a Phase III trial in the US, based on satisfactory results from the ongoing Phase Ib/II study. In addition, the FDA agreed that D-PLEX would be reviewed under the 505(b)(2) approval pathway. D-PLEX was also recently designated as a Qualified Infectious Disease Product (QIDP) by the FDA, enabling the company to take advantage of certain incentives, including FDA priority review, eligibility for fast-track status and an additional 5 years of market exclusivity when marketing approval is granted for D-PLEX in preventing post-cardiac surgery sternal infection.

PolyPid’s lead product, D-PLEX, is a secure antibiotic drug reservoir that provides a safe and effective local anti-bacterial prevention 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 biopharmaceutical company developing, manufacturing, and commercializing products based on its PLEX proprietary platform, with an initial focus on the prevention and treatment of post-surgical site infections. PLEX-based products have demonstrated an excellent safety profile during extended clinical studies, with over 100 patients exposed to the technology to date. For more information, visit www.polypid.com.