TEL AVIV, Israel, Oct. 5, 2017 /PRNewswire/ -- Galmed
Pharmaceuticals, Inc. (GLMD), a clinical-stage biopharmaceutical
company focused on the development of a once-daily, oral therapy
for the treatment of nonalcoholic steatohepatitis, or NASH and
other liver diseases, today announced the publication of a paper
entitled "Role of Aramchol™ in steatohepatitis and fibrosis in
mice" in Hepatology Communications, a peer-reviewed, online
open access journal.
The paper summarizes the work conducted by a collaboration of
key international, basic and clinical scientists, who are well
known NASH experts. "The paper reinforced the previously published
effects of Aramchol on steatosis in patients,ˮ said Dr.
Liat Hayardeny, Chief Scientific
Officer of Galmed. Dr. Hayardeny continued, "The data have helped
us understand the mechanism by which Aramchol exerts its effect on
steatosis and steato-fibrosis and identify its potential direct
anti fibrotic effectsˮ.
Prof. José M Mato, senior author, and director of CIC bioGUNE
commented, "We have identified two disparate consequences of
Aramchol treatment that result in antisteatotic, anti-inflammatory
and antifibrotic effects. Aramchol treatment improved
steatohepatitis and steato-fibrosis by decreasing SCD1 and by
maintaining cellular redox homeostasis. Our MCD model resembles the
metabolic phenotype observed in NASH patients, which supports the
potential use of Aramchol for this indication.ˮ
Prof. Arun Sanyal, co-author, and
Professor of Medicine and Chairman, Division of Gastroenterology,
Hepatology and Nutrition at the Virginia
Commonwealth University (VCU) department of Internal
Medicine and Chairman of the NIH NASH Clinical Research Network and
the Liver Forum for NASH and fibrosis added: "This pre-clinical
study provides a strong pathophysiological rationale for the use of
Aramchol. The results of the ongoing clinical trial are now eagerly
awaited.ˮ
"The ongoing ARREST Phase IIb study is designed to evaluate the
efficacy and safety of two Aramchol doses versus placebo
in patients with NASH. One of the key secondary endpoints is
measuring the ability of Aramchol to improve fibrosis without
worsening of NASH, and over 60% of the 248 enrolled patients showed
advanced fibrosis at baseline biopsy," said Dr. Tali Gorfine, Chief
Medical Officer of Galmed. Top line ARREST study data are expected
to be available in Q2 2018.
The company will present the preclinical data at the Liver
Meeting® AASLD which will take place in Washington D.C., 20-24
October 2017.
The paper can be accessed online at:
http://onlinelibrary.wiley.com/doi/10.1002/hep4.1107/full
About Methionine and Choline Deficiency (MCD) Mouse
Model:
Feeding mice a methionine and choline deficient (MCD)
diet constitutes a commonly used nutritional model of NASH that
induces aminotransferase elevation and changes in hepatic
histological features characterized by steatosis, local
inflammation, hepatocyte necrosis and fibrosis. These changes
occur rapidly and have been shown to be morphologically close to
those observed in human NASH.
About AramcholTM and Non-alcoholic Steatohepatitis
(NASH)
AramcholTM (arachidyl amido cholanoic
acid) is a novel fatty acid bile acid conjugate, inducing
beneficial modulation of intra-hepatic lipid metabolism.
AramcholTM'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
AramcholTM on fibrosis is mediated by down regulation of
steatosis and directly on human collagen producing cells.
AramcholTM 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 is a
clinical-stage biopharmaceutical company focused on the development
of AramcholTM, a first in class, novel, once-daily, oral
therapy for the treatment of NASH for variable populations, as well
as other liver associated disorders. 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 AramcholTM 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 Aramchol 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 identifiers: 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. 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 ongoing Phase IIb ARREST
Study, and planned Phase III trials for AramcholTM, or
whether Phase III trials will be conducted at all; completion and
receiving favorable results of these Phase IIb ARREST Study and
Phase III trials for AramcholTM; regulatory action with
respect to AramcholTM by the FDA or the EMA; the
commercial launch and future sales of AramcholTM or any
other future products or product candidates; Galmed's ability to
comply with all applicable post-market regulatory requirements for
AramcholTM in the countries in which it seeks to market
the product; Galmed's ability to achieve favorable pricing for
AramcholTM; Galmed's expectations regarding the
commercial market for NASH in patients who are overweight or obese
and have pre diabetes or type II diabetes mellitus; third-party
payor reimbursement for AramcholTM; Galmed's estimates
regarding anticipated capital requirements and Galmed's needs for
additional financing; market adoption of AramcholTM by
physicians and patients; the timing, cost or other aspects of the
commercial launch of AramcholTM; the development and
approval of the use of AramcholTM 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 23, 2017, 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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