FREMONT, Calif.--(BUSINESS WIRE)--Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, presented today at the late breaking plenary session of the American Society of Nephrology (ASN) / Kidney Week positive results from a Phase 2 clinical study, which demonstrated treatment with QPI-1002 significantly reduced the incidence of acute kidney injury (AKI) following cardiac surgery. There are no currently available therapies to prevent or treat AKI, which is a serious condition that results in patients requiring dialysis and is associated with significantly increased mortality risk. The Quark trial, QRK209 (NCT02610283), was a global multicenter study that included 341 subjects of age 45 or greater and at risk for AKI undergoing cardiac surgery, randomized in a 1:1 ratio to QPI-1002 or placebo. The primary endpoint for the study, the proportion of subjects developing AKI through Day 5, based on the Acute Kidney Injury Network (AKIN) classification, was achieved, with QPI-1002 treatment significantly reducing the incidence of AKI from 50% in the control group to 37% in the QPI-1002 treatment group, achieving a risk reduction of 26% (p = 0.02). QPI-1002 also reduced the duration of AKI and the severity of AKI (p = 0.01 for both).
The QPI-1002 treatment effect observed in the overall study population was consistent in predefined subgroups of subjects including those with chronic kidney disease (CKD), diabetes, and high-risk patients who underwent multiple cardiovascular surgical procedures. Importantly, in those subjects at a higher risk of AKI (with prior history of reduced renal function, proteinuria or diabetes) longer term renal function assessed by the occurrence of death, need for dialysis or reduction in renal function by 25% by Day 90, were improved by QPI-1002 treatment with a risk reduction of 29% (p=0.024). Safety profiles were similar between QPI-1002 and placebo. The presentation on behalf of the QRK209 Study Group was delivered by David Corteville, MD, FACC, CPE, Director of Cardiovascular Imaging, McLaren Northern Michigan, a lead investigator in the study.
“These are very encouraging results from a global study,” stated Dr. Corteville. “There is no specific treatment that is available for these patients, and this is the first time a drug has had such positive results in a large Phase 2 study in this serious condition.”
Dr. Shai Erlich, CMO and President of USA operations of Quark Pharmaceuticals stated, “We are grateful for the patients, the investigators, and their study teams who contributed to this groundbreaking study. We look forward to continuing development of this important treatment and are very pleased that this demonstration of improvement of renal function in patients at risk for AKI after cardiac surgery represents the second set of successful Phase 2 results  for QPI-1002, following our Phase 2 study (NCT00802347) in delayed graft function after renal transplantation, which is currently in a Phase 3 clinical trial (NCT02610296).”
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 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% compared to the overall mortality rate of 2–8% after cardiac surgery. In patients who develop non-dialysis requiring AKI, the risk of short and long term mortality is increased up to 4- fold 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 pivotal clinical studies. Quark’s broad pipeline of clinical and preclinical product candidates is generated from the company’s internally-developed siRNA 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.
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