TEL AVIV, Israel, Dec. 17, 2020 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company for liver, metabolic and
inflammatory diseases announced today the addition of an open-label
part to its ARMOR Phase 3 registrational study. All currently
enrolled patients in both arms will be given the opportunity to
transition to an active regimen of Aramchol. This is designed to
evaluate treatment response kinetics, pharmacokinetics (PK) and
safety of twice daily administration (BID) of Aramchol 300mg in
approximately 150 subjects at various time points with the results
of a second biopsy coming as early as 24 weeks after initiation of
treatment. The 150 patients are expected to be comprised of both
current ARMOR patients as well as new patients.
Separately, Galmed is announcing new data from a Phase 1, first
in human (FIH) study that compared Aramchol meglumine to Aramchol
acid. These initial results demonstrate that the new salt form of
Aramchol meglumine has a plasma PK profile that is very similar to
Aramchol acid. It also shows that the administration of both forms
results in the same form of Aramchol in the blood, regardless of
which drug product is administered.
Allen Baharaff, Galmed co-founder and CEO commented "The
addition of the open-label part to our ARMOR study will give us an
important early readout of twice daily Aramchol 300mg, which in a
previously reported PK study significantly increased plasma levels,
as well as provide us with other important data in support of the
ARMOR registrational study. Furthermore, over the last few
years, Galmed has been in the process of developing a new product,
Aramchol meglumine, which is a salt form of Aramchol free acid. We
have now shown with our first in human PK data that Aramchol
meglumine and Aramchol free acid, the drug substance that is
currently being evaluated in our ARMOR Phase 3 study, circulate in
the blood as Aramchol regardless of which drug product is
administered. The markedly higher solubility of Aramchol meglumine
results in lower variability which is a significant added benefit.
By developing a salt version of Aramchol, we are able to take the
important step towards gaining patent protection on the drug until
2035. We plan to submit these results along with other supportive
data to the FDA and discuss with the FDA a plan to introduce
Aramchol meglumine into the randomized placebo-controlled part of
the ARMOR Phase 3 study. This is all part of our overall strategy
to optimize our clinical development program towards a Sub-part H
filing and approval."
All subjects enrolled into the open-label part of ARMOR will
receive 300mg of Aramchol BID. Patients will be randomized (1:1:1)
into 3 groups with post-baseline liver biopsy being
performed at 24 weeks, 48 weeks, or 72 weeks, respectively. The
first data milestone is expected when approximately one-third of
the study population (~ 50 subjects) has completed 24 weeks of
treatment, followed shortly by a second data milestone after
one-third of the population has completed the on-treatment liver
biopsy.
The new open label part will enroll a broader study population
than the initial ARMOR protocol defined, including subjects with
NASH and liver fibrosis stage 1-3, subjects with NASH who may or
may not be overweight, and subjects with NASH who may or may not
have type 2 diabetes (T2DM) or be pre-diabetic.
The open label part of ARMOR will also provide information about
the utility of state-of-the-art non-invasive tests (including ProC3
and ELF) and imaging that may be able to provide early predictions
for histology responses to Aramchol and long-term safety data to
support the planned histology-based Sub-part H submission to the
FDA for regulatory approval.
The open label part will be conducted in a smaller subset of the
ARMOR sites; approximately 50 selected sites in the U.S., and
around the world which have been less affected by the COVID-19
pandemic. The Company is expecting the first of the planned 150
patients to be enrolled in the first quarter of 2021 and expects
the first histology data to be reported by the fourth quarter of
2021.
In light of the rapid development of the Aramchol meglumine
program and due to the delays resulting from the COVID-19 pandemic,
randomization of new patients into the double-blind,
placebo-controlled histology-based registrational part of ARMOR
will be temporarily suspended as currently enrolled patients are
transitioned to open label. This will allow the capture and
reporting of important data from ARMOR much earlier than previously
expected. It will also help to ensure a seamless introduction
of the new Aramchol meglumine into the double-blind,
placebo-controlled part of ARMOR, which is expected to resume by
the fourth quarter of 2021.
Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université,
and Hospital Pitié Salpêtrière, Paris,
France and the ARMOR study co-principal investigator
commented "the open-label part aims to help bridge the gap between
current histology-based trials and future real-world practice where
biomarkers will be extensively used to assess candidates for
therapy and treatment response. It also addresses an important
practical question which is to determine the individual dynamics of
treatment response; this is expected to provide evidence-based
knowledge with the prospect of optimizing the benefit of Aramchol
300mg BID and other future NASH therapies."
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 collaborating with
the Hebrew University in the development of Amilo-5MER, a
5 amino acid synthetic peptide and plan to initiate a first in
human study by the first quarter of 2021.
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 12, 2020, 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.