- Statistically significant clinical and histology
improvements were also demonstrated in a model of inflammatory
bowel disease (IBD)
- Data reinforcing the expansion of Aramchol's Clinical
Development to Additional Indications
TEL
AVIV, Israel, July 7, 2022
/PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD)
("Galmed" or the "Company"), a clinical-stage biopharmaceutical
company for liver, metabolic, fibrosis and inflammatory diseases,
announced today results showing significant effects of Aramchol in
pre-clinical model of both lung and gastrointestinal (GI)
fibrosis.
Fibrosis is a common complication of chronic inflammation and
can affect all organs and tissues. To date, only limited
anti-fibrotic drugs are approved or are in development, most of
which have restricting side effects. Aramchol is a partial
inhibitor of SCD1 with distinctive, direct, anti-fibrotic activity
demonstrated in several pre-clinical models.
Treatment with Aramchol resulted in statistically significant
fibrosis improvement in a validated bleomycin model of lung
fibrosis (IPF), comparable to Pirfenidone which is the gold
standard treatment. Findings were seen across all important
indicators for the severity of fibrosis including hydroxyproline (a
marker for collagen deposition in the fibrotic tissue) P< 0.05,
Ashcroft score P < 0.005, % CPA (Percentage Collagen
Proportionate Area of the lung) P < 0.001, and
immunohistochemistry (type I collagen and a SMA) P < 0.005 for
both staining.
Statistically significant improvements were also demonstrated in
a validated DSS model of inflammatory bowel disease (IBD). Dextran
sulfate sodium (DSS) induced colitis model is widely used because
of its similarities with human ulcerative colitis. Clinical
improvements were statistically significant at least by p value
< 0.05 while in histological score (based on inflammation and
colon structural changes) significance was as low as p<0.01.
Aramchol was found to be the most effective compound tested.
Control groups included 5-ASA and local steroids which are the gold
standards for current treatment.
Galmed continues to assess Aramchol's anti-fibrotic effects also
in kidney and skin.
"I am excited with today's news showing that established data
about the role of SCD1 in lipid metabolism and fibrosis in the
liver, is being replicated in other organs. Today we show that
Aramchol's effect is evident in other organs, such as lung and
gastrointestinal tract and may be as substantial as the one
observed in the liver. The new findings, together with the robust
anti-fibrotic effects demonstrated in clinical studies of patients
with NASH and advanced fibrosis could potentially enable Galmed to
quickly transition to Phase 2/3 clinical studies with Aramchol in
indications with unmet need and faster development pathways."
stated Allen Baharaff co-founder, President and CEO of Galmed."
About Idiopathic pulmonary fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a severe, chronic,
progressive, fibrotic interstitial disease of unknown etiology,
which remains an unmet need despite approved treatments which are
limited by side effects. Bleomycin, an anti-neoplastic agent that
causes lung fibrosis in human patients, has been used extensively
in rodent models to mimic IPF and serves as the standard agent for
induction of experimental pulmonary fibrosis in animals. Bleomycin
reproduces typical features of the human disease.
About 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. Galmed is also collaborating with the
Hebrew University in the development of
Amilo-5MER, a 5 amino acid synthetic peptide.
About Aramchol
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.
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; Galmed's expectations regarding
licensing, acquisitions and strategic operations; and the outcome
of any evaluation of Galmed's strategic alternatives. 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
May 2, 2022, 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.