FDA approves IND for SR/Quark's AKI drug

London, UK-based SR Pharma says that the US Food and Drug Administration has approved an Investigational New Drug application for a second siRNA therapeutic based on its unique proprietary chemistry. The product is AKIi-5, which is being developed by local drugmaker Quark Biotech for the treatment of acute kidney injury (AKI).

Quark licensed the agent from SR's subsidiary Atugen and its structure and composition of matter is protected by Atugen's patent portfolio. AKIi-5 is Quark's lead product candidate in development for AKI in high-risk patients undergoing major cardiovascular surgery. The product is expected to reduce the frequency of post-surgery AKI requiring dialysis as well as AKI-associated mortality. Last month, the AtuRNAi compound RTP-801i, which SR sub-licensed to Pfizer through Quark, for the treatment of age-related macular degeneration, entered clinical testing.