Data Readout from Phase Ib/II Study Expected by End of 2017
Company Intends to Seek Regulatory Approvals in U.S. and Europe in 2018 to Conduct a Phase III Clinical Trial of D-PLEX™
PETAH TIKVA, Israel IAugust 16, 2017 I PolyPid Ltd., a clinical-stage biopharmaceutical company with an initial focus on the prevention and treatment of post-surgical site infections, today 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 U.S. 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 PLEXTM 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 U.S. Food and Drug Administration (FDA) in which the FDA agreed that D-PLEX™ can move directly into a Phase III trial in the U.S., 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 five-years of market exclusivity when marketing approval is granted for D-PLEX™ in preventing post-cardiac surgery sternal infection.
About D-PLEX
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.
About PolyPid
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.
SOURCE: PolyPid
Post Views: 21
Data Readout from Phase Ib/II Study Expected by End of 2017
Company Intends to Seek Regulatory Approvals in U.S. and Europe in 2018 to Conduct a Phase III Clinical Trial of D-PLEX™
PETAH TIKVA, Israel IAugust 16, 2017 I PolyPid Ltd., a clinical-stage biopharmaceutical company with an initial focus on the prevention and treatment of post-surgical site infections, today 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 U.S. 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 PLEXTM 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 U.S. Food and Drug Administration (FDA) in which the FDA agreed that D-PLEX™ can move directly into a Phase III trial in the U.S., 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 five-years of market exclusivity when marketing approval is granted for D-PLEX™ in preventing post-cardiac surgery sternal infection.
About D-PLEX
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.
About PolyPid
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.
SOURCE: PolyPid
Post Views: 21
