Delayed graft function (DGF) represents Quark’s second indication being evaluated for the systemically administered drug candidate in human clinical trials. This trial follows two currently enrolling Phase I clinical trials in acute kidney injury (AKI).
The multi-center, two-part Phase I/II clinical trial in DGF is expected to enroll up to 204 adult kidney transplant recipients. The first part of the study is a dose-escalation design to evaluate the safety and tolerability of a single intravenous injection of QPI-1002 in renal transplant patients at high risk to develop DGF.
The second part of the study will evaluate safety and potential clinical activity of a selected dose of QPI-1002 in the same patient population. Patients will be enrolled in clinical sites in the US.
The investigational drug candidate QPI-1002 is a siRNA designed to temporarily inhibit the expression of the pro-apoptotic gene, p53. This siRNA is based on Quark’s patented therapeutic concept of temporarily inhibiting the expression of p53 to protect normal cells from acute injury.
Shai Erlich, chief medical officer of Quark, said: The initiation of patient dosing with QPI-1002 is an important milestone for Quark as well as being an innovative approach to offer therapeutic benefit to adult kidney transplant patients at high risk for developing DGF.