Therapy Areas: Cardiovascular
PolyPid Ltd awarded US FDA second QIDP designation for D-PLEX100 for prevention of post-abdominal surgery incisional infection
22 May 2019 -

Biopharmaceutical company PolyPid Ltd said on Tuesday that it has received US Food and Drug Administration (FDA) second Qualified Infectious Disease Product (QIDP) designation for its lead drug product candidate D-PLEX100 for the prevention of post-abdominal surgery incisional infection.

Previously, the company's D-PLEX100 had received both QIDP designation and Fast Track status from the US FDA for the prevention of sternal wound infection post cardiac surgery, one of the most devastating complications with a mortality rate of up to 40% when deep sternal infection occurs.

Following the US FDA QIDP, the company now plans to start its Phase 3 clinical trial in cardiac surgery in the second half of 2019,with more than 140 patients already enrolled and with the top-line results expected in the second half of 2019

Upon administration of D-PLEX100 into the surgical site, the PLEX technology enables the prolonged and constant release of high local concentration of broad-spectrum antibiotic for a period of four weeks, allowing effective prevention of infection after surgery with increased potential to eradicate antibiotic resistant bacteria.

Additionally, the company's technology and products are based on the inventions of its founder and chief scientific officer Dr Noam Emanuel. Its PLEX-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.