QPI-1002 misses in graft function Phase II
The Quark Pharmaceuticals Inc. subsidiary of SBI Biotech Co. Ltd. (Tokyo, Japan) said a single IV dose of QPI-1002 missed the primary endpoint vs. placebo in the Phase II portion of the Phase I/II QRK.006B trial to prevent delayed graft function (DGF) after renal transplantation. Specifically, in 327 evaluable dialysis-dependent patients with end-stage kidney disease, QPI-1002 given 30 minutes after circulatory reperfusion did not lead to at least a 30% relative risk reduction of DGF -- defined as the need for dialysis within the first seven days post-transplant -- vs. placebo. DGF occurred in 30.9% of patients who received QPI-1002 vs. 36.4% for placebo (p=0.349). A post hoc analysis showed QPI-1002 led to an approximate 30% risk reduction of DGF relative to placebo in subgroups of patients who received kidney grafts from donors 35 years of age and older and 45 years of age and older. Data were presented at the World Transplant Conference in San Francisco. ...