Quark Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration for QPI-1002, an investigational drug designed to protect kidneys from cellular damage that can occur following transplantation.
Quark has completed enrollment and dosing in the dose-escalation safety portion of a Phase I/II study to progress the drug to the second portion (Part B) of the study to evaluate the safety and potential clinical activity of QPI-1002.
QPI-1002 is the first systemic siRNA drug to enter human clinical trials for delayed graft function (DGF), the most common complication during the immediate post-operative period in renal transplantation.
Quark Pharmaceuticals president and CEO Daniel Zurr said that DGF is an unmet medical need, and the company anticipates a great deal of interest in QPI-1002 from the renal transplant community.
“We are confident that obtaining orphan status will facilitate the rapid development of this innovative compound and hope that ultimately we can reduce the wait time for kidney transplants with fewer failed grafts,” Zurr said.
US orphan drug designation is granted to products intended to treat a rare disease or condition affecting fewer than 200,000 Americans.