China to Join Galmed's Phase 3
ARMOR Registrational Study for the Treatment of NASH &
Fibrosis
TEL AVIV, Israel, May 3, 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 National Medical
Products Administration (NMPA) has granted approval for the
Investigational New Drug (IND) application for Galmed's Phase 3
ARMOR registrational study of Aramchol for the treatment of NASH
& Fibrosis.
"With the increasing globalization of drug development, it has
become essential that data from multi-regional clinical trials
(MRCTs) is accepted by regulatory authorities across regions and
countries as the primary source of evidence, to support and
facilitate efficient marketing approval of drugs," said Allen
Baharaff, Chief Executive Officer of Galmed. "In line with these
considerations, the ARMOR study was designed as an MRCT in
approximately 215 centers located in U.S., Europe, Latin
America, Australia, and now
China. Being granted the trial
approval by the NMPA is of great significance as it brings us a
step closer to offering an optimized new oral therapy to patients
with NASH and fibrosis who now have very limited treatment
options."
The ARMOR study is evaluating the efficacy and safety of
Aramchol in subjects with NASH and fibrosis stages 2-3 who are
overweight or obese and have prediabetes or type 2 diabetes. The
study consists of two parts. The first part is an open-label study
that is designed to evaluate the treatment response,
pharmacokinetics and safety of twice daily administration (BID) of
Aramchol 300mg and explore the kinetics of histological outcome
measures as well as several non-invasive tests (including ProC3,
ELF and Fibroscan) associated with NASH and fibrosis for the
treatment duration of 24, 48 and 72 weeks. The second part is a
randomized, double-blind, placebo-controlled study with a
histology-based surrogate endpoint that is intended to serve as the
basis for the submission of a marketing authorization application
under regulatory provisions of accelerated/conditional approval.
All subjects will continue with the same treatment assignment until
study completion to confirm clinical efficacy. More information
about the ARMOR Study may be found on ClinicalTrials.gov
identifier: NCT04104321.
Nonalcoholic fatty liver disease (NAFLD), a precursor of NASH,
has an estimated prevalence rate in China that is expected to increase from
15%-20% in 2018 to 25%-30% in 2033, driven by increasing prevalence
of obesity and type 2 diabetes.
"The approval of the IND application of the ARMOR Study in
China is a significant milestone
in the development of Aramchol for NASH patients," said Prof.
Junqi Niu, Chief Physician, The
First Hospital of Jilin University
and ARMOR China Principal Investigator. "Drug development is
globalizing with worldwide interaction, licensing, and
cross-licensing as regional studies are recognized unfeasible and
China has the size and resources
to become a leader in pharmaceutical innovation. I am delighted
that China will be taking part in
the ARMOR regulatory Phase 3 study of Aramchol which is one of the
most advanced therapeutic candidates for NASH and Fibrosis. We look
forward to rapidly initiating enrollment in China later in H2 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.
About 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 collaborating with the
Hebrew University in the development of
Amilo-5MER, a 5 amino acid synthetic peptide.
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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