TEL AVIV, Israel, Aug. 16, 2021 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company for liver, metabolic and
inflammatory diseases announced today that the Medicines and
Healthcare products Regulatory Agency (MHRA), the
pharmaceuticals regulator in the UK, agreed with Galmed's plan to
proceed with its proposed clinical studies with Aramchol meglumine
in lieu of Aramchol free acid without the need to repeat
nonclinical and clinical studies other than planned limited
pharmacology studies relating to Aramchol meglumine. This follows
similar agreement received from the FDA that was recently
announced.
Aramchol meglumine is an improved compound using a salt form of
Aramchol that has significantly greater water solubility than the
free acid and an NCE patent protection valid until December 2034. Aramchol meglumine circulates in
the blood as Aramchol.
Allen Baharaff, Galmed co-founder and CEO commented: "Our shift
to Aramchol meglumine is part of our overall optimization strategy
for our Phase 3 ARMOR study and the MHRA's agreement, which follows
on the heels of the FDA's agreement, represents important
validation of the steps that we are taking." Mr. Baharaff continued
"We are fully focused on the open label part of our Phase 3 ARMOR
Study and look forward to presenting the results of the first
one-third of patients during the fourth quarter of 2021."
About Aramchol and Non-alcoholic Steatohepatitis
(NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid
bile acid conjugate, liver targeted SCD1 modulator, developed as an
oral therapy for the treatment of nonalcoholic steatohepatitis
("NASH") and fibrosis. 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.
Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Our lead compound, Aramchol™, a backbone drug candidate
for the treatment of NASH and fibrosis is currently in a Phase 3
registrational study. We are also developing Amilo-5MER, a 5 amino
acid synthetic peptide and recently initiated a first in human
study.
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. Many factors could cause Galmed's actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, the following: the timing and cost of Galmed's
pivotal Phase 3 ARMOR trial, or the ARMOR Study or any other
pre-clinical or clinical trials; completion and receiving favorable
results of the ARMOR Study for Aramchol or any other pre-clinical
or clinical trial; the impact of the COVID-19 pandemic; regulatory
action with respect to Aramchol or any other product candidate by
the FDA or the EMA; the commercial launch and future sales of
Aramchol or any other future products or product candidates;
Galmed's ability to comply with all applicable post-market
regulatory requirements for Aramchol or any other product candidate
in the countries in which it seeks to market the product; Galmed's
ability to achieve favorable pricing for Aramchol or any other
product candidate; Galmed's expectations regarding the commercial
market for NASH patients or any other indication; third-party payor
reimbursement for Aramchol or any other product candidate; Galmed's
estimates regarding anticipated capital requirements and Galmed's
needs for additional financing; market adoption of Aramchol or any
other product candidate by physicians and patients; the timing,
cost or other aspects of the commercial launch of Aramchol or any
other product candidate; the development and approval of the use of
Aramchol or any other product candidate for additional indications
or in combination therapy; and Galmed's expectations regarding
licensing, acquisitions and strategic operations. More detailed
information about the risks and uncertainties affecting Galmed is
contained under the heading "Risk Factors" included in Galmed's
most recent Annual Report on Form 20-F filed with the SEC on
March 18, 2021, 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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