QPI-1002: Phase II data

Data from 327 evaluable end-stage kidney disease dialysis-dependent patients undergoing deceased donor kidney transplantation in the Phase II portion of the double-blind, international Phase I/II QRK.006B trial showed that a single IV dose of 10 mg/kg QPI-1002 given 30 minutes after circulatory reperfusion was achieved to the transplanted organ missed the primary endpoint of a >=30% relative risk reduction of DGF, defined as the need for dialysis within the first 7 days post-transplant excluding dialysis in the first 24 hours due to hyperkalemia/hypervolemia, vs. placebo (15.1% risk reduction relative to placebo). Specifically, DGF occurred in 30.9% of patients who received QPI-1002 vs. 36.4% for placebo (p=0.349). At the end of the 6-month observation period, QPI-1002 reduced the total number of dialysis sessions in all evaluable patients vs. placebo (375 vs. 561 sessions, p=0.059).

A subgroup analysis by donor type of patients who received Expanded Criteria Donor kidneys entirely Cold Stored (ECD/CS, n=177) showed that QPI-1002 led to a 30.5% risk reduction of DGF relative to placebo. Specifically, DGF occurred in 27.3% of patients who received QPI-1002 vs. 39.3% for placebo (p=0.111). Additionally in the ECD/CS subgroup, QPI-1002 significantly increased dialysis-free survival in the first post-transplant month (HR=0.626, p=0.04), reduced the mean duration of the first course of dialysis (13.4 vs. 25.3 days, p=0.292) and reduced the number of dialysis sessions required in the first 30 days post-transplant (6 vs. 11.2, p=0.271) vs. placebo. Additionally, a post hoc analysis showed that QPI-1002 led to an approximate 30% risk reduction of DGF relative to placebo in both subgroups of patients who received kidney grafts from donors >=35 years old and >=45 years old. Data were presented at the World Transplant Congress in San Francisco. ...