About Acute Kidney Injury (AKI)
AKI is a serious clinical condition that complicates approximately 5% of hospital admissions and up to 30% of admissions to intensive care units. In patients undergoing major cardiovascular surgery, post-surgical AKI develops within hours to days as a result of ischemic conditions caused by reduced local blood flow to the kidneys during surgery and so-called reperfusion injury following restoration of the blood flow. The rate of AKI development in most patients undergoing cardiovascular surgery is low, but the rate can be as high as 22-39% (depending upon AKI definition) in high-risk patients. The 30-day mortality rate following onset of AKI after surgery is greater than 50% . The prognosis among patients requiring dialysis after cardiac surgery is poor, with an increased mortality risk exceeding 60%, however, the risk of short and long term mortality is increased up to 4- fold in patients who develop non-dialysis requiring AKI compared to patients with normal renal function after cardiac surgery . AKI is an unmet medical need, with no specific treatment available.
QPI-1002 is the first systemic siRNA drug to enter human clinical trials and to complete several well-controlled clinical studies with efficacy endpoints that were conducted in hundreds of patients. It is an investigational drug designed to temporarily inhibit the expression of the pro-apoptotic gene, p53, to protect normal cells from death stemming from acute tissue injury. Preclinical studies have shown that p53-targeted siRNAs can protect kidneys from ischemia-reperfusion injury in a variety of clinically relevant animal models. QPI-1002 has been granted Orphan Drug designation in the USA and Europe for prophylaxis of delayed graft function following kidney transplantation. Under an August 2010 agreement, Novartis has an exclusive worldwide license option for the development and commercialization of QPI-1002.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc. is a world leader in discovery and development of novel small interfering RNA, or siRNA, therapeutics for unmet medical needs. RNA interference is a biological process in which RNA molecules regulate expression of targeted genes. Quark’s fully integrated drug discovery and development platform spans the process from therapeutic target identification to drug development. Two products, QPI-1002 for delayed graft function (DGF) following kidney transplantation and QPI -1007 for non-arteritic ischemic optic neuropathy (NAION), have been granted orphan designation and are in global Phase 2/3 pivotal clinical studies. Quark’s broad pipeline of clinical and preclinical product candidates is generated from the company’s internally-developed siRNAi platform technology and focuses on extrahepatic indications. In July this year, Quark has successfully completed a randomized double-blinded Phase 2 trial exploring efficacy of QPI-1002 in prevention of acute kidney injury (AKI) following cardiac surgery that met the primary and multiple secondary endpoints. Novartis has an option to license this product. Another Quark’s siRNA pipeline drug, PF-655 is licensed to Pfizer. Quark is headquartered in Fremont, California and operates research facilities in Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.