NEW YORK (GenomeWeb) – Quark Pharmaceuticals this week announced that it has completed a Phase II trial of its siRNA-based drug for the prevention of delayed graft function in kidney transplant patients.
Data from the study are slated for presentation later in July at the 2014 World Transplant Conference.
The drug, QPI-1002, is designed to silence p53 and is currently in clinical testing for two indications: preventing delayed graft function in patients undergoing deceased donor kidney transplantation and preventing ischemia-reperfusion-induced kidney injury in patients removed from a cardiopulmonary bypass pump.
In the just-completed Phase II trial, 332 patients were randomized to receive either a 10 mg/kg single bolus IV dose of QPI-1002 or placebo at 30 minutes following reperfusion. The primary endpoint was the incidence of delayed graft function, with secondary endpoints including dialysis occurrence, duration, and severity per patient immediately after transplantation and during the follow up period, and certain kidney function parameters.