Quark siRNA meets Phase II kidney injury endpoint
Quark Pharmaceuticals Inc. (Fremont, Calif.) said QPI-1002 met the primary endpoint in a Phase II trial to prevent acute kidney injury (AKI) following cardiac surgery. Novartis AG (NYSE:NVS; SIX:NOVN) has an option to obtain exclusive, worldwide rights to the short interfering RNA that temporarily inhibits p53 expression (see BioCentury Extra, Aug. 18, 2010).
In the 341-patient QRK-209 trial, a single IV dose of QPI-1002 significantly reduced the incidence of AKI over five days compared to placebo. Quark CEO Daniel Zurr told BioCentury that the p-value associated with the outcome was “much better" than 0.05. The company said the treatment effect in the overall population was “consistent” across subsets of patients with chronic kidney disease (CKD) and diabetes, as well as high-risk patients who underwent multiple cardiovascular surgeries...