Quark Pharmaceuticals Inc. reported completion of a randomized, placebo-controlled multicenter Phase 2 trial of QPI-1002 for the prophylaxis of delayed graft function (DGF) in ESRD dialysis-dependent patients undergoing deceased donor kidney transplantation. The results of the trial will be presented at the 2014 World Transplant Conference in San Francisco, as an oral presentation in the late-breaking session on July 28. Novartis has an exclusive worldwide license option for the development and commercialization QPI-1002.
The study was a placebo-controlled, randomized, prospective, double-blind, multicenter, Phase 32 study of the safety and clinical activity of Quark’s siRNA compound QPI-1002, which is the first siRNA compound to be used systemically in human clinical trials. The Phase 2 trial enrolled 332 patients randomized to receive deceased donor organs, primarily from extended criteria donors (ECD). The study involved 52 centers in the United States, Canada, France, Germany and Spain. The study subjects were randomized 1:1 to receive 10 mg/kg single bolus IV dose of QPI-1002 or placebo at 30 minutes following reperfusion.
The primary endpoint was the incidence of DGF, assessed as the incidence of dialysis as defined per protocol (the necessity for dialysis during the first 7 days following the transplantation, with the exclusion of dialysis given due to specific DGF-unrelated reasons that were prospectively defined in the protocol). The secondary end points included a set of parameters measuring other definitions of DGF, dialysis occurrence, duration and severity per patient immediately after transplantation and during the follow up period (up to 6 month post-transplant) as well as kidney function parameters.
“We are pleased to have completed this study as planned, and we look forward to sharing the exciting results at the upcoming WTC meeting,” said Dr. Daniel Zurr, CEO of Quark. “Delayed graft function adversely affects outcomes following deceased donor kidney transplantation and is a significant problem for which there is currently no approved treatment. We hope that QPI-1002 could improve outcomes and encourage greater utilization of deceased donor kidneys allowing the use of additional kidneys and shortening the transplant waiting list.”
Date: July 1, 2014