TEL AVIV, Israel, April 9, 2019 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of the liver targeted SCD1 modulator, Aramchol, an oral therapy for
the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis,
announced today that the company has completed its
End-of-Phase 2 meeting with the Food and Drug Administration (FDA)
and reached general agreement on key aspects of the Phase 3/4
development and registration plan for Aramchol and on the pivotal
registration study ARMOR. ARMOR is a Phase 3/4 multinational,
multicenter, double-blind, placebo-controlled clinical study to
evaluate the efficacy, safety and tolerability of Aramchol in
subjects with NASH and fibrosis.
Galmed previously announced results from its Phase 2b study which were subsequently presented at
AASLD 2018. Efficacy and safety data from this study included
notable effects on key registrational endpoints of NASH resolution
and fibrosis improvement and favorable safety supporting initiation
of the Phase 3/4 study. More recently, Galmed reported results from
a study comparing once daily Aramchol 600 mg to twice daily 300 mg
with a significant increase in exposure in the twice daily
treatment arm and potential for additional efficacy with twice
daily dosing. General agreement has been reached with FDA on key
aspects of the ARMOR study including patient population, study
endpoints, study dose and treatment duration. Galmed plans on
submitting its study protocol and other design elements of its
ARMOR trial to the FDA in the coming weeks with study commencement
expected in the third quarter of 2019.
Galmed plans on presenting an overview of its development plan
of Aramchol at the NASH Summit in Boston on April 24,
2019.
About Aramchol and Non-alcoholic Steatohepatitis
(NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid
bile acid conjugate, inducing beneficial modulation of
intra-hepatic lipid metabolism. Aramchol's ability to modulate
hepatic lipid metabolism was discovered and validated in animal
models, demonstrating downregulation of the three key pathologies
of NASH: steatosis, inflammation and fibrosis. The effect of
Aramchol on fibrosis is mediated by downregulation of steatosis and
directly on human collagen producing cells. Aramchol has been
granted Fast Track designation status by the FDA for the treatment
of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5%
of the U.S. population and an estimated 2% to 4% globally. It is
the fastest growing cause of liver cancer and liver transplant in
the U.S. due to the rise in obesity. NASH is the progressive form
of non-alcoholic fatty liver disease that can lead to
cardiovascular disease, cirrhosis and liver-related mortality.
About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on
the development of Aramchol, a first in class, novel, oral therapy
for the treatment of NASH for variable populations. Galmed recently
announced top-line results of the ARREST Study, a multicenter,
randomized, double blind, placebo-controlled Phase 2b 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.
Galmed is currently preparing to initiate a Phase 3/4 clinical
study in the third quarter of 2019.
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 23,
2017, 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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