TEL AVIV, Israel, Nov. 13, 2018 /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, a once-daily, oral
therapy for the treatment of nonalcoholic steatohepatitis ("NASH")
and fibrosis, announced today the oral abstract presentation of
one-year results of the Company's global Phase 2b ARREST study of Aramchol in patients with
non-alcoholic steatohepatitis (NASH). These results were presented
during a Late Breaking Abstract Oral Session at The Liver Meeting®
2018 during the American Association for the Study of Liver
Diseases 2018 Annual Meeting being held in San Francisco.
Additionally, the Company's oral abstract of the Phase 2 ARREST
study has been selected by the American Association for the Study
of Liver Diseases for inclusion in The Best of The Liver Meeting
2018.
The ARREST study enrolled 247 NASH patients who were
overweight/obese and had prediabetes/diabetes with HbA1C at
baseline of 6.6%. More than 50% were hypertensive and had
dyslipidemia. Baseline histology demonstrated a population with
advanced disease, with 60% having stage 2 and 3 fibrosis and 70%
having NAS≥5.
In this one-year study, Aramchol showed liver fat reduction,
biochemical improvement, NASH resolution and fibrosis reduction.
Results favored the 600mg dose with a dose response pattern. In
particular, compared to placebo, the Aramchol 600mg arm achieved
the following endpoints:
- NASH resolution without worsening of fibrosis – a regulatory
approval endpoint in NASH Phase 3 trials
- Fibrosis stage reduction without worsening of NASH - a
regulatory approval endpoint in NASH Phase 3 trials
- Decrease in ALT and AST
- Better glycemic control (HbA1C)
Aramchol showed excellent safety and tolerability profiles with
a low discontinuation rate, no weight loss and no change in lipid
parameters.
To view the slide presentation of the ARREST study data
presented at the Late Breaking Oral Session go to:
http://galmedpharma.investorroom.com/download/Aramchol_Late-Breaking_liver_meeting+AASLD_2018.pdf
"The results favor Aramchol 600 mg therapeutic potential for
testing in a Phase 3 trial," said Prof. Vlad Ratziu, France, principal investigator of the ARREST
trial. "The higher proportion of resolution of steatohepatitis
together with the potential for direct fibrosis improvement and
excellent safety and tolerability place Aramchol among the most
promising candidates in development for NASH patients."
"Aramchol is a once daily, liver target, oral medication with an
excellent safety profile that has now clearly demonstrated in a
large Phase 2b study, in patients
with advanced NASH, results on the two important biopsy-based
endpoints key for further assessment in a NASH pivotal study," said
Allen Baharaff, President and Chief Executive Officer of Galmed
Pharmaceuticals. "We are advancing Aramchol into a Phase 3
registration trial with the planned initiation of the ARMOR pivotal
study at the end of the second quarter or early in the third
quarter of 2019."
ARREST is a multicenter, Phase 2b,
randomized, double blind, placebo-controlled study designed to
evaluate the efficacy and safety of two Aramchol doses (400 and 600
mg tablets) in patients with NASH confirmed by liver biopsy who
were overweight or obese and who were pre- diabetic or type II
diabetic. Top line results from the study were released by Galmed
on June 12, 2018.
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 down regulation of the three key pathologies
of NASH; steatosis, inflammation and fibrosis. The effect of
Aramchol™ on fibrosis is mediated by down regulation of steatosis
and directly on human collagen producing cells. Aramchol™ has been
granted by the FDA Fast Track designation status 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, once-daily,
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 IIb
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 for an end of Phase IIb meeting with the FDA to discuss
the results of the ARREST Study and a Phase III study protocol,
with a view to initiating a Phase III clinical study of Aramchol in
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. 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
planned Phase III trial for Aramchol, or whether a Phase III trial
will be conducted at all; completion and receiving favorable
results of a Phase III trial for Aramchol or any other pre-clinical
or clinical trial; regulatory action with respect to Aramchol 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 in the countries in which it
seeks to market the product; Galmed's ability to achieve favorable
pricing for Aramchol; Galmed's expectations regarding the
commercial market for NASH; third-party payor reimbursement for
Aramchol; Galmed's estimates regarding anticipated capital
requirements and Galmed's needs for additional financing; market
adoption of Aramchol by physicians and patients; the timing, cost
or other aspects of the commercial launch of Aramchol; the
development and approval of the use of Aramchol 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 13, 2018, 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.