Pharmaprojects R&D Pipeline News Feed
Quark initiates Phase I trial of novel siRNA product for acute renal failure
30 Nov 2007
Quark Pharmaceuticals has announced that it has progressed AKIi-5, a small interfering RNA (siRNA) therapeutic for the treatment of acute renal failure (ARF), into a Phase I clinical trial. The placebo-controlled, double-blind trial is assessing safety and pharmacokinetics in cardiac surgery patients and is being conducted in Europe, Israel and the US.
Although there are siRNAs in higher stages of development than AKIi-5, such as Opko Health's bevasiranib sodium, these are designed only for local administration such as intraocularly or via inhalation. This Phase I trial with AKIi-5 marks the first clinical systemic administration of siRNA in humans.
The trial is expected to be completed in 2008, with a Phase II dose-ranging study planned, depending on results. Daniel Zur, CEO of Quark said that initiation of human dosing marked a “very important milestone in the RNAi industry”.
AKIi-5 is a modified siRNA molecule that selectively and temporarily inhibits the expression of p53, a gene that plays a key role in the aetiology of ARF by inducing apoptosis in renal cells. Preclinical studies of AKIi-5 have shown the molecule to be effective in protecting kidneys from ischeamia reperfusion injury, and in preventing the development of ARF in rats. Quark licensed AKIi-5 from Silence Therapeutics.
ARF is a high mortality condition associated with a rapid decline in renal function caused by ischaemia-reperfusion (IR) injury to the kidneys following coronary bypass surgery. There is currently a significant treatment void for ARF, with no approved therapies available for treatment or prevention.
