Quark Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidne...
July 09 2018 - 7:00AM
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
ContactQuark Pharmaceuticals, Inc.Investor Relations:Gavin
SamuelsSVP, Corporate Development & Investor Relations +1 510
402 4020 gsamuels@quarkpharma.com
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