MODI'IN, Israel, Aug. 29, 2016 /PRNewswire/ -- Exalenz Bioscience
(TASE: EXEN), a leader in developing and marketing non-invasive
medical devices for diagnosing and monitoring a range of
gastrointestinal and liver diseases, today announced a
collaboration with Conatus Pharmaceuticals Inc. (Nasdaq: CNAT) to
use the BreathID® Methacetin Breath Test (MBT) to monitor patients
in a planned Phase IIb clinical trial evaluating emricasan.
Emricasan is an investigational treatment for patients with chronic
liver disease, being developed by Conatus.
The ENCORE-PH multicenter, randomized, double-blind,
placebo-controlled clinical trial, expected to begin in 2016, is
designed to evaluate the safety and efficacy of emricasan in
patients with liver cirrhosis associated with nonalcoholic
steatohepatitis (NASH) and severe portal hypertension. Enrolled
participants will receive two breath-based tests: the first during
the screening stage and the second at week 24. The results will be
used to investigate the clinical utility of the BreathID® MBT at
quantitating improvements in liver function compared with standard
medical tests including hepatic venous pressure gradient (HVPG) and
Model for End-stage Liver Disease (MELD) score. Exalenz
recently received approval from the U.S. Food and Drug
Administration (FDA) of an investigational device exemption (IDE)
for the trial.
"To date, emricasan has been studied in more than 650 subjects
in 16 clinical trials across a broad range of liver diseases," said
David T. Hagerty, M.D., Conatus'
Executive Vice President, Clinical Development. "In multiple
clinical trials, emricasan has demonstrated statistically
significant improvements in clinically important validated
surrogate endpoints of portal hypertension and liver function. We
are pleased to be partnering with Exalenz Bioscience to further
validate how their novel, non-invasive, breath-based technology can
be used to monitor patients treated for NASH cirrhosis. The data
from the BreathID® will provide valuable information to Conatus in
the development of novel medicines to treat liver disease, and in
bringing new non-invasive diagnostic options to patients."
"It has been reported that NASH affects 2 to 5 percent of the
U.S. population," said Raffi Werner,
chief executive officer of Exalenz Bioscience, "in addition to the
10 to 20 percent of the population with fatty liver without
inflammation. Currently the only valid measures for diagnosis and
follow up are invasive liver biopsy and HVPG. We are honored to
collaborate with Conatus in the upcoming multicenter clinical trial
and believe that our non-invasive, operator-independent,
breath-based test has the potential to assist clinicians to
conveniently and cost-effectively monitor the effect of therapy at
the point of care."
This collaboration is the latest addition to Exalenz's growing
clinical pipeline of investigational diagnostic applications
utilizing BreathID® to diagnose serious liver diseases. In addition
to three trials related to NASH diagnostics and monitoring, the
company has ongoing clinical trials for detection of hepatocellular
carcinoma (HCC), diagnosis of clinically significant portal
hypertension (CSPH) and monitoring of acute liver failure
(ALF).
About Exalenz Bioscience:
Exalenz Bioscience develops and markets diagnostic and
monitoring systems that use the breath to diagnose and help manage
gastrointestinal and liver conditions. The company's flagship
BreathID® Hp test detects the presence of the H. pylori bacteria,
associated with various illnesses including gastric cancer and is
in use in over 350 US medical centers. Exalenz holds regulatory
approvals in Europe, the United States, China and Israel for H. pylori detection and is
currently in the process of obtaining approvals for additional
applications. Additional information is available at
www.exalenz.com.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development
and commercialization of novel medicines to treat liver disease.
Conatus is developing its lead compound, emricasan, for the
treatment of patients with chronic liver disease. Emricasan is a
first-in-class, orally active pan-caspase protease inhibitor
designed to reduce the activity of enzymes that mediate
inflammation and apoptosis. Conatus believes that by reducing the
activity of these enzymes, emricasan has the potential to interrupt
the disease progression across the spectrum of liver disease.
Additional information is available
at www.conatuspharma.com.
About Nonalcoholic Steatohepatitis (NASH)
NASH is a progressive form of nonalcoholic fatty liver disease
(NAFLD), characterized by inflammation caused by excess fat in
liver cells that is not related to alcohol consumption[i]. NASH
dramatically increases the risks of cirrhosis, liver failure, and
hepatocellular carcinoma (HCC), and is an increasingly frequent
reason for liver transplantation[ii]. Currently, a liver biopsy is
the only way to definitively diagnose the condition.
Forward-looking Statement
This press release contains forward-looking statements with
respect to plans, projections or future performance of the Company,
the occurrence of which involves certain risks and uncertainties,
some of which may not be under the control of Exalenz, including,
but not limited to, changes in regulatory environment, Exalenz's
success in implementing its research, development, sales, marketing
and manufacturing plans, protection and validity of patents and
other intellectual property rights, the impact of currency exchange
rates and the effect of competition.
[i] http://www.liverfoundation.org/abouttheliver/info/nafld/
[ii]
http://www.worldgastroenterology.org/assets/export/userfiles/2012_NASH%20and%20NAFLD_Final_long.pdf
Contact:
Nir Zalik
Investor Relations
T: +972-3-516-7620
nir@km-ir.co.il
www.km-ir.co.il
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SOURCE Exalenz Bioscience