TEL AVIV, Israel, Sept. 22, 2016 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of a once-daily, oral therapy for the treatment of liver diseases,
today announced that it has signed an Investigator-Initiated
Clinical Trial Agreement with the University
of California, San Diego, School of Medicine (the
"University"). The proposed study is a Phase I/IIa trial to
assess safety, tolerability, efficacy, and pharmacokinetics of
AramcholTM in a juvenile population with nonalcoholic
fatty liver disease (NAFLD) (the "ARTISAN Study"). The
ARTISAN Study (ARamcholTM Trial to
Improve Steatosis in Adolescent NAFLD)
is to be led by Dr. Jeffrey
Schwimmer, Professor of Clinical Pediatrics at the
University.
Fatty liver disease in children has been increasingly recognized
as an important pediatric health problem. Pediatric NAFLD has
some features that are similar to adults and several features that
are unique to children. In the United States, there are an
estimated 5 to 8 million children with NAFLD. The prevalence
of NAFLD in children across the developed world is 5 to 10%.
From a liver standpoint, the major concern is that NAFLD is a
risk factor for cirrhosis and liver cancer. Beyond the risk
for serious liver problems, children with NAFLD are also at
increased risk for other important health problems including type 2
diabetes and atherosclerotic heart disease.
"NAFLD is the leading cause of chronic liver disease, yet there
is no approved therapy in children or adults. Based upon
promising data in adults, the University is developing a
proof-of-concept trial for AramcholTM in adolescents
with NAFLD," said Jeffrey Schwimmer,
MD, professor of pediatrics, University of
California, San Diego, School of Medicine and Director,
Fatty Liver Clinic, Rady Children's Hospital, San Diego.
The ARTISAN Study is subject to receipt of regulatory approvals
and is currently expected to be initiated in the first half of
2017.
Galmed's President and Chief Executive Officer, Mr. Allen Baharaff, stated "The ARTISAN Study marks
the third investigator-initiated clinical trial and continues our
strategy of collaborating with leading investigators to evaluate
AramcholTM's efficacy across different populations and
indications. We believe addressing the unmet need for treatment of
juvenile population with NAFLD should not await the clinical
development for adults. Based on AramcholTM's
safety profile and mechanism-of-action, we decided to approach this
important indication in parallel with our ongoing adult
studies."
About Nonalcoholic Fatty Liver Disease and Nonalcoholic
Steatohepatitis:
Nonalcoholic fatty liver disease (NAFLD) is
the most common cause of chronic liver disease in the United States and it affects almost 30% of
adults in Western countries. With climbing obesity rates and more
sedentary patient populations, the prevalence of NAFLD is
increasing worldwide and is becoming the predominant cause of
chronic liver disease in parts of the world. NAFLD represents a
spectrum of diseases ranging from simple excess liver fat, or
steatosis, to nonalcoholic steatohepatitis (NASH). NASH is the
progressive form of fatty liver disease that can lead to
cardiovascular disease, cirrhosis and liver-related mortality in
persons who drink little or no alcohol. NASH represents the more
severe end of this spectrum and is characterized by steatosis,
ballooning degeneration and lobular inflammation with or without
fibrosis. Long-term risks of NASH include cardiovascular disease,
cirrhosis, hepatocellular carcinoma and end stage liver disease
requiring liver transplantation.
About Galmed Pharmaceuticals Ltd.:
Galmed is a
clinical-stage biopharmaceutical company focused on the development
of a novel, once-daily, oral therapy for the treatment of liver
diseases utilizing its proprietary first-in-class family of
synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed
believes that its product candidate, Aramchol™, has the potential
to be a disease modifying treatment for fatty liver disorders,
including NASH, which is a chronic disease that Galmed believes
constitutes a large unmet medical need. Galmed is currently
conducting the ARREST Study, a multicenter, randomized, double
blind, placebo-controlled Phase IIb clinical study designed to
evaluate the efficacy and safety of Aramchol™ in subjects with
NASH, who are overweight or obese, and who are pre-diabetic or
type-II-diabetic. More information about the ARREST Study may be
found on ClinicalTrials.gov identifier: NCT02279524.
Forward-Looking Statements:
This press release may
include forward-looking statements. Forward-looking
statements may include, but are not limited to, statements relating
to Galmed's objectives, plans and strategies, as well as
statements, other than historical facts, that address activities,
events or developments that Galmed intends, expects, projects,
believes or anticipates will or may occur in the future.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements. Applicable risks and uncertainties include
risks and uncertainties associated with the initiation, timing,
progress and results of the Company's research, preclinical studies
and clinical trials as well as risks and uncertainties identified
under the heading "Risk Factors" included in Galmed's most recent
Annual Report on Form 20-F filed with the Securities and Exchange
Commission, or the SEC, on March 22,
2016, and in other filings that Galmed has made and may make
with the SEC in the future. The forward-looking statements
contained in this press release are made as of the date of this
press release and reflect Galmed's current views with respect to
future events, and Galmed does not undertake and specifically
disclaims any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
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