Quark's QPI-1002 meets Phase II kidney injury endpoint

Quark Pharmaceuticals Inc. (Fremont, Calif.) reported data from a Phase II trial in 341 patients at high risk of acute kidney injury (AKI) following cardiac surgery showing that a single dose of IV QPI-1002 met the primary endpoint of reducing the incidence of AKI as defined by Acute Kidney Injury Network (AKIN) criteria through day 5 vs. placebo. Quark also said the treatment effect observed in the overall population was “consistent” across subgroups of patients with chronic kidney disease (CKD) and diabetes, as well as high-risk patients who underwent multiple cardiovascular surgeries. QPI-1002 was well tolerated.

A secondary endpoint in the double-blind, international trial was the proportion of patients developing ≥1 of death, needing renal replacement therapy during the 90-day postoperative period, or a ≥25% reduction in serum creatinine levels based on estimated glomerular filtration rate (eGFR) at the day 90 visit...