Novartis Ally Quark Wraps Up siRNA Lead Phase 2 Trial
Quark Pharmaceuticals announced that it has completed the Phase II trial of siRNA compound for the prophylaxis of delayed graft function (DGF) in ESRD dialysis-dependent patients undergoing donor kidney transplant.
QPI-1002 is an investigational siRNA compound that works to inhibit the expression of p53, a pro-apoptotic gene, to shield normal cells from injury. Novartis holds an exclusive global license option for the development and commercialization of QPI-1002. The lead compound has been given Orphan Drug designation in both U.S. and the EU.
The randomized, placebo-controlled, double-blind, prospective, multicenter, Phase II study evaluated the safety and clinical activity of QPI-1002 in 332 patients randomized to receive deceased donor organs. The trial’s primary endpoint was the incidence of delayed graft function (DGF) while secondary endpoints included dialysis occurrence, kidney function, and other DGF definitions.
Dr. Daniel Zurr, CEO of Quark, said, “We are pleased to have completed this study as planned, and we look forward to sharing the exciting results at the upcoming WTC meeting. Delayed graft function adversely affects outcomes following deceased donor kidney transplantation and is a significant problem for which there is currently no approved treatment.”
Delayed graft function affects 25 to 40 percent of deceased donor renal transplant recipient and often results from ischemia/reperfusion injury. This usually takes place when blood flows back into the transplanted kidney and leads to a chain of events that result in severe renal damage. DGF is linked to higher rates of graft rejection and decreased graft survival.
Dr. Zurr said, “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.”
The company said it will present the results of the trial at the 2014 World Transplant Conference to be held in San Francisco this July.