SR Pharma plc announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application (IND) for a second siRNA therapeutic which is based on the company 's unique proprietary chemistry. The product is AKIi-5, which is being developed by Quark Biotech Inc for the treatment of Acute Kidney Injury (AKI). This product was licensed to Quark Biotech Inc. by SR Pharma'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 for the prevention of Acute Kidney Injury 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. AKI is a very serious disease with a 50-70% mortality rate in patients developing it in the intensive care unit and up to 88% in patients developing the disease following major cardiovascular surgery. Over the past 40 years, the survival rate for AKI has not improved. In patients at the highest risk-level, AKI incidence is 22%.
Iain Ross, Executive Chairman of SR Pharma stated, "We are very excited by this achievement, as this is the second product based upon our proprietary AtuRNAi chemistry which has been approved for use in humans. Only last month we announced that the AtuRNAi compound RTP-801i, which we sub-licensed to Pfizer through our partner Quark Biotech Inc. for the treatment of Age-related Macular Degeneration, was moving into the clinic."