TEL AVIV, Israel,, Jan 9, 2017 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of Aramchol, a once-daily, oral therapy for the treatment of liver
diseases including Non-Alcoholic Steato-Hepatitis (NASH), announced
today that it has completed recruitment for its Phase IIb ARREST
study ("ARREST Study").
The ARREST Study is a global, multi-center, randomized, double
blind, placebo-controlled, Phase IIb clinical trial evaluating the
treatment effects and safety of Aramchol in 240 patients with
biopsy proven NASH who are overweight or obese, and who are
pre-diabetic or type-II-diabetic. The ARREST Study duration is 52
weeks with 12 weeks' follow-up period. Results are anticipated to
be announced in Q2 2018.
The ARREST Study primary endpoint, previously demonstrated in a
Phase IIa study, is reduction in liver fat content measured by
magnetic resonance spectroscopy (MRS). The secondary
histological endpoints include improvement of fibrosis, two-point
improvement in NAS (NAFLD Activity Score) and resolution of NASH.
The ARREST Study will also evaluate surrogate metabolic
endpoints.
Patients enrolled in the ARREST Study have advanced NASH with
more than 60% having fibrosis in stages 2 (19%) and 3 (42%) and a
mean NAS score of 5.
"ARREST is a global NASH study, operating across four continents
including North America,
Europe, LatAm and China. "The design of the study took advantage
of lessons learned from other large Phase II studies by enrolling a
population at increased risk for disease progression." stated Allen
Baharaff President and chief executive officer of Galmed.
"The ARREST study is the largest study to date to incorporate
both MRI and histology endpoints. I expect that Aramchol will
demonstrate the effects seen in pre-clinical and clinical studies
on the three pathologies of NASH: steatosis, inflammation and
fibrosis", commented Professor Vlad
Ratziu, the ARREST Study's global principal investigator.
Professor Ratziu continued, "The ARREST Study is a fully global
outreach trial with spectacular rates of inclusion from numerous
investigators. This speaks to the excitement for testing Aramchol
and generating a large set of data on invasive and non-invasive
assessments that will move the field of liver diseases forward, but
also, more generally, to the potential of conducting large clinical
trials globally which will be the key to further phase III
developments".
About Aramchol and Non-alcoholic Steatohepatitis
(NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel
fatty acid bile acid conjugate, causing beneficial modulation of
intra-hepatic lipid metabolism. Aramchol's ability to modulate
hepatic lipid metabolism was discovered and validated in numerous
animal species and models by leading Israeli and European research
groups led by the Company's founder, the late Prof. Tuvia Gilat. Recently, anti-inflammatory and
anti- fibrotic effects were observed in mice treated with Aramchol
using a methionine-choline deficient (MCD) diet treatment model and
rats' prevention thioacetamide (TAA) model.
To date, over 400 subjects have been dosed with Aramchol in five
Clinical trials, including the ARREST Study. Our Phase IIa Study
with 60 nonalcoholic fatty liver disease (NAFLD) and NASH patients
demonstrated that Aramchol 300mg per day significantly reduced
liver fat content after 12 weeks of treatment.
The FDA granted Fast Track designation status to Aramchol for
the treatment of NASH.
NASH is an emerging health crisis impacting 3% to 5% of the U.S.
population and 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 fatty liver
disease that can lead to cardiovascular disease, cirrhosis and
liver-related mortality in persons who drink little or no
alcohol.
About Galmed Pharmaceuticals Ltd.:
Galmed is a
clinical-stage biopharmaceutical company focused on the development
of a novel, once-daily, oral therapy for the treatment of
nonalcoholic steatohepatitis, or NASH and liver diseases utilizing
its proprietary first-in-class family of synthetic
fatty-acid/bile-acid conjugates, or FABACs. Galmed is
currently conducting 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 also sponsors the ARRIVE Study, a
proof-of-concept Phase IIa clinical trial designed to evaluate the
safety and efficacy of Aramachol in up to 50 patients with
HIV-associated NAFLD and lipodystrophy. The ARRIVE Study is an
investigator-initiated trial, conducted at the University of California San Diego by Professor
Rohit Loomba. More information about
the ARREST Study and the ARRIVE Study may be found on
ClinicalTrials.gov identifieries: NCT02279524 and NCT02684591,
respectively.
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. Applicable
risks and uncertainties include risks and uncertainties associated
with the initiation, timing, progress and results of the Company's
research, preclinical studies and clinical trials as well as risks
and uncertainties identified under the heading "Risk Factors"
included in Galmed's most recent Annual Report on Form 20-F filed
with the Securities and Exchange Commission, or the SEC, on
March 22, 2016, 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.