Breaking News
August 17, 2018 - Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
August 17, 2018 - Study shows DNA methylation related to liver disease among obese patients
August 17, 2018 - Life on the border: Back at Stanford, ready to pitch in
August 17, 2018 - New device for accurately placing hemodialysis catheters on kidney patients
August 17, 2018 - New strategy accelerates, automates process of prototype molecule optimization
August 17, 2018 - Study finds role of autoimmunity in development of COPD
August 17, 2018 - Researchers transform research tool to study neuronal function
August 17, 2018 - Cognitive impairment does not equate to unhappiness in older adults
August 17, 2018 - Peer Comparisons Can Decrease Risky Prescribing Patterns
August 17, 2018 - Susceptible genes identified for childhood chronic kidney disease
August 17, 2018 - Research uncovers miscarriage cause, identifies potential targets for treatment
August 17, 2018 - Bacterial armor could be new target for antibiotics | News Center
August 17, 2018 - FDA expands approval of Vertex’ cystic fibrosis medicine to treat children aged 12 to
August 17, 2018 - Give Your Child a Head Start With Math
August 17, 2018 - Ground-breaking study tests whether rejected livers can be made viable for transplantation
August 16, 2018 - New algorithm could improve diagnosis of rare diseases | News Center
August 16, 2018 - SCHILLER introduces latest generation of ECG device, CARDIOVIT AT-102 G2
August 16, 2018 - Proper treatment, refraining from smoking can reduce heart disease risk from type 2 diabetes
August 16, 2018 - Mount Sinai study could transform treatment for patients with retinal degenerative diseases
August 16, 2018 - Penn researchers develop first mouse model of idiopathic pulmonary fibrosis
August 16, 2018 - Four tips to help prevent fall allergy symptoms
August 16, 2018 - Women’s Preventive Services Initiative says screen all women annually for urinary incontinence
August 16, 2018 - At Stanford, patient discovers the source of her headaches, nausea | News Center
August 16, 2018 - To Prevent Injuries in Young Baseball Players, Chris Ahmad Reaches Out to Parents
August 16, 2018 - Restoring blood flow may be linked to longer survival in patients with critical limb ischemia
August 16, 2018 - New model of genetically engineered immune cells may help fight solid tumors
August 16, 2018 - Maternal stress increases anxious and depressive-like behaviors in female offspring
August 16, 2018 - Childhood exposure to secondhand smoke increases risk of COPD death in adulthood
August 16, 2018 - Scientists uncover key control mechanism of DNA replication
August 16, 2018 - NIH begins first-in-human trial of experimental live, attenuated Zika virus vaccine
August 16, 2018 - Two diabetes medications don’t slow progression of type 2 diabetes in youth
August 16, 2018 - 5 Questions: How Stanford research is making MRI scans safer for kids | News Center
August 16, 2018 - Columbia Celebrates 25th Anniversary of White Coat Ceremony
August 16, 2018 - Phonak’s new smallest and most discreet Virto B-Titanium hearing aid
August 16, 2018 - New project aims to study growth of water-based microorganisms
August 16, 2018 - Immune cell found to play important role in photosensitivity
August 16, 2018 - Higher social dominance linked to faster decision-making in men
August 16, 2018 - Blood test in early pregnancy could determine a woman’s later risk for gestational diabetes
August 16, 2018 - New research confirms link between DDT exposure and autism
August 16, 2018 - Neurodevelopmental Anomalies, Birth Defects Linked to Zika ID’d
August 16, 2018 - Risk of heart failure up in ALVSD patients with diabetes
August 16, 2018 - Exercise reduces symptoms and fatigue in patients with chronic kidney disease
August 16, 2018 - Study reveals role of RUNX proteins in DNA repair
August 16, 2018 - New research finds no harm from average salt consumption
August 16, 2018 - Researchers develop new way of testing bacterial resistance to antibiotics
August 16, 2018 - Magnetic gene in aquarium fish could open doors to treatment for epilepsy, Parkinson’s
August 16, 2018 - Five tips for successful long-term breastfeeding
August 16, 2018 - Researchers identify brain networks involved in object naming
August 16, 2018 - Promoting HPV Vaccine Doesn’t Prompt Risky Sex by Teens: Study
August 16, 2018 - Treating Rheumatoid Arthritis: Search for a Cure
August 16, 2018 - Research shows in the long run, charcoal toothpaste likely won’t whiten teeth
August 16, 2018 - Seattle Children’s opens new clinic to provide convenient access to pediatric specialty care services
August 16, 2018 - Curious case of the lost contact lens
August 16, 2018 - GN Hearing unveils world’s first Premium-Plus hearing aid
August 16, 2018 - Parental life span linked with increased longevity and health in daughters
August 16, 2018 - Health leaders reveal ten most important medicines in NHS history
August 16, 2018 - Mobile health devices diagnose hidden heart condition in at-risk populations
August 16, 2018 - When it comes to shedding pounds, it pays to think big
August 16, 2018 - Liva Healthcare announces appointment of Thomas Cooke as clinical services manager in the UK
August 16, 2018 - New digital pharmacy aims to help people living with chronic care conditions
August 16, 2018 - Preventing ACL injuries in high school athletes
August 16, 2018 - Experts provide insight into novel concepts and approaches for stroke rehabilitation
August 16, 2018 - Scientists reverse congenital blindness in mouse model
August 16, 2018 - Study shows link between use of benzodiazepines and increased risk of Alzheimer’s disease
August 16, 2018 - Study provides new insight into how ‘trash bag of the cell’ traps and seals off waste
August 16, 2018 - Trial shows PARP inhibitor as novel treatment option for patients with advanced breast cancers
August 16, 2018 - Prenatal exposure to violence increases toddlers’ aggressive behavior to their mothers
August 16, 2018 - Can manipulating gut microbes improve cardiac function in patients with heart failure?
August 16, 2018 - Hearts of newborn piglets can completely heal after heart attacks
August 16, 2018 - Ablating the mutant p53 gene in mice with colorectal cancer inhibits tumor growth
August 16, 2018 - Higher BMI in people with prediabetes related to evening preference and lack of sufficient sleep
August 16, 2018 - Using peripheral nerve blocks to treat facial pain may produce long-term pain relief
August 16, 2018 - Neural stem cells are the key to tail regeneration
August 16, 2018 - Study compares genetic and neural contributions to ADHD in children with or without TBI
August 16, 2018 - Adding energy drinks to alcohol may exacerbate negative effects of binge drinking
August 16, 2018 - Eye Examination Can Help Detect Abuse in Children
August 16, 2018 - Know the Difference: Rheumatoid Arthritis or Osteoarthritis?
August 16, 2018 - From ‘sea of mutations,’ two possible cancer links rise to the surface
August 16, 2018 - Does medical school take too long?
August 16, 2018 - Brown University researchers reveal key physical properties of ‘giant’ cancer cells
Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

image_pdfDownload PDFimage_print

Fremont, CA – July 9, 2018 – 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, today announced the first patient dosed in the pivotal Phase 3 clinical trial of QPI-1002 a siRNA targeting p53, for the prevention of acute kidney injury (AKI) and its consequences following cardiac surgery (CS) (Trial QRK309, NCT03510897).

The Phase 3 trial is a double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of QPI-1002 in patients undergoing cardiac surgery. Eligible patients will be randomized to receive either a single dose of QPI-1002 by IV injection or placebo. The study will enroll approximately 1,038 subjects at high risk for AKI following cardiac surgery at 115 sites globally.

The primary endpoint of the QRK309 trial will be the proportion of subjects who develop any of the components of Major Adverse Kidney Events at Day 90 (MAKE90), defined as: Death through day 90, Initiation of Renal Replacement Therapy (RRT) through day 90, or an equal to or greater than 25% reduction in estimated glomerular filtration rate (eGFR based on serum cystatin C (eGFRcys) at the Day 90 visit. The traditional analyte for eGFR, a measure of renal function, is serum creatinine (SCr) which will also be assessed in the study in a sensitivity analysis for the primary endpoint.

In July 2017, Quark reported positive Phase 2 data from its large multicenter Phase 2 QRK209 (NCT02610283) clinical trial with QP-1002 for the prevention of AKI. In this trial, QPI-1002 demonstrated a 29% relative risk reduction in the MAKE90 endpoint (p=0.024) in the same patient population and same components of MAKE90 as in the primary endpoint of the current QRK309 Phase 3 trial. In addition, the Phase 2 study met its primary endpoint – it significantly reduced the incidence, severity and duration of AKI within the first five days of surgery in high risk patients (p = 0.0204) – as well as other multiple secondary endpoints.

“We are excited to announce the initiation of patient dosing in this Phase 3 trial with QPI-1002 using this important innovative endpoint which was designed based on our clinical Phase 2 data. This is an important milestone for Quark, building on our success from our Phase 2 study, towards enabling a potential new therapeutic option for cardiac surgery patients at high risk for developing AKI which is a serious complication of cardiac surgery and remains a major unmet medical need,” stated Dr. Elizabeth C. Squiers, Chief Medical Officer of Quark Pharmaceuticals, Inc.

“Moving forward with a Phase 3 trial with a new investigational product using this important MAKE90 endpoint based on Cystatin C, is an important advance in clinical trials for AKI,” stated Dr. Madhav Swaminathan Intensivist at Duke University Medical Center, Durham NC, one of the participating sites in the study. “Cystatin has been reported to potentially be a better way to estimate renal function in some patients at risk of renal deterioration” and as also recommended in the KDIGO guidelines. [1]

The same molecule QPI-1002 also completed dosing of 594 patients in a pivotal Phase 3 study (QRK306, NCT02610296) for delayed graft function (DGF) following kidney transplantation in January 2018. As in the AKI trial, the company reached agreement with the FDA on the overall Phase 3 trial design with a new innovative primary endpoint for DGF, based on the DGF Phase 2 data (QRK006, NCT00802347). We anticipate receiving the first interpretative results (FIR) in the fourth quarter of 2018.

More information can be found on QRK309 at or www.clinicaltrials.gov, identifier: NCT03510897

About Acute Kidney Injury (AKI)

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 reperfusion injury following restoration of the blood flow. Over 60% of cardiac surgery patients have moderate to high risk of AKI [2]. 40% or more have AKI. 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 [3]. AKI is an unmet medical need, with no specific treatment available.

About QPI-1002

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. Quark is headquartered in Fremont, California and operates research facilities in Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.

[1] Kellum, J. A., Lameire, N., Aspelin, P., Barsoum, R. S., Burdmann, E. A., Goldstein, S. L., … Uchino, S. (2012). Kidney disease: Improving global outcomes (KDIGO) acute kidney injury work group. KDIGO clinical practice guideline for acute kidney injury. Kidney International Supplements, 2(1), 1-138. DOI: 10.1038/kisup.2012.1

[2] Am Jour Trans vol14 S3 p153 abstract #2967

[3] The Annals of Thoracic Surgery 93.1 (2012): 337–347. PMC. Web. 6 Sept. 2015

Source: Quark Pharmaceuticals, Inc.

Posted: July 2018

Tagged with:

About author

Related Articles