TEL AVIV, Israel, October 11, 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 one-year results of
the global Phase 2b randomized
placebo-controlled ARREST Trial of Aramchol in patients with NASH
have been published in Nature Medicine
(https://www.nature.com/articles/s41591-021-01495-3).
The ARREST Phase 2b study
randomized 247 patients with NASH confirmed by liver biopsy.
Patients were randomized 2:2:1 to receive Aramchol 400mg, 600mg or
placebo once daily. The manuscript describes the complete data
analyses including reduction in liver fat by imaging, improvements
in liver histology and liver enzymes as well as the very good
safety profile of Aramchol.
Aramchol is the most advanced down regulator of SCD 1 in
clinical development. Aramchol, by targeting this single receptor,
an important metabolic master switch, induces cascade of events
that leads to two main changes: in hepatocytes, Aramchol elevates
the fatty acids oxidation (or in other words – fat burn) and
influences AMPK, which results also in reducing glycemic
parameters; and in hepatic stellate cells, Aramchol down regulates
collagen production (i.e. fibrosis). Data from the ARREST Phase
2b study published in this paper
demonstrate how the mechanism of action of Aramchol translates into
clinical performance.
This published study, in addition to mechanistic studies
demonstrated and published thus far, provided the rationale for the
continued development of Aramchol for patients with NASH and
fibrosis and a potential to further improved efficacy using higher
drug exposure (>50% higher).
The ARMOR study - a Phase 3, multinational, multicenter,
randomized, double-blind, placebo-controlled clinical study to
evaluate the efficacy and safety of Aramchol 300mg twice daily in
subjects with NASH with an open-label part to evaluate the safety,
PK and treatment response kinetics of Aramchol is currently ongoing
(NCT04104321).
Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université,
the paper's lead author and the ARMOR study co-principal
investigator commented "The publication of the detailed results of
the ARREST trial in a prestigious general medical journal such as
Nature Medicine speaks to the interest of the scientific community
towards this molecule with an innovative mode of action and its
potential for treating fibrotic NASH. We look forward to seeing the
impact of an optimized Aramchol exposure in NASH patients from the
Phase 3 ARMOR trial"
"The publication of these data in Nature Medicine speaks to the
strong interest from the clinical community in this unmet need
area. We are grateful to all the patients and clinical sites that
participated in the study around the world", said Allen Baharaff,
President and Chief Executive Officer of Galmed. "Coupled with new
recent publications elucidating Aramchol's MoA and particularly its
direct effect on fibrosis, these results underscore the significant
potential of Aramchol as a therapeutic option for patients
diagnosed with NASH and Fibrosis. We are committed to evaluating
the safety and efficacy of Aramchol in patients diagnosed with NASH
and Fibrosis in our ongoing ARMOR Phase 3 study."
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.
There are currently no approved therapies for NASH.
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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SOURCE Galmed Pharmaceuticals Ltd.