Policy & Regulation
PolyPid passes US FDA clearance to launch clinical trial of D-PLEX[100] for the prevention of sternal wound infection
13 November 2018 -

Biopharmaceutical company PolyPid Ltd said on Monday that it will proceed with its phase 3 clinical trial of its lead asset D-PLEX[100] for the prevention of post-cardiac surgery sternal Infections following the US Food and Drug Administration (FDA) review of the IND.

This phase 3 clinical trial is a prospective, multinational, multicentre, randomised, single blind, study to assess the efficacy and safety of D-PLEX[100] in prevention of post-cardiac surgery sternal infections.

Following the US FDA approval, the multinational Phase 3 study is expected to start in the first half of 2019.

The company's lead product candidate, D-PLEX[100], is a novel product designed to provide local anti-bacterial activity directly at the surgical site to prevent surgical site infections. Following D-PLEX[100] administration into the surgical site, the drug reservoir constantly releases the entrapped broad-spectrum antibiotic in a controlled manner over a predetermined period of four weeks, thus allowing prolonged infection management with increased potential to eradicate antibiotic resistant bacteria.

According to the company, its transformational PLEX (Polymer-Lipid Encapsulation Matrix) -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.