TEL AVIV, Israel, Aug. 19, 2021 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company for liver, metabolic and
inflammatory diseases announced today the publication in The
Journal of Autoimmunity for its IND ready compound, Amilo-5MER
entitled: "MTADV 5-MER peptide suppresses chronic inflammations as
well as autoimmune pathologies and unveils a new potential
target-Serum Amyloid A."
Amilo-5MER, is a five amino acid in a specific sequence that was
originally isolated from synovial fluid of rheumatoid arthritis
(RA) patients. This human peptide displays an efficient
anti-inflammatory effect to ameliorate pathology and clinical
symptoms in mouse models of RA, inflammatory bowel disease (IBD)
and multiple sclerosis (MS). The presumed MoA by which Amilo-5MER
affects chronic inflammation is binding to SAA and preventing its
ability to activate immune cells for pro inflammatory cytokine
secretion.
Studies have demonstrated that Amilo-5MER significantly inhibits
the release of pro-inflammatory cytokines IL-6 and IL-1β from SAA
activated human fibroblasts, THP-1 monocytes and peripheral blood
mononuclear cells. Amilo-5MER suppresses the pro-inflammatory IL-6
release from SAA-activated cells, but not from non-activated cells
providing selective anti inflammatory properties.
Prof. David Naor, a winner
of 2021 Kaye Prize for scientific innovation and affiliated
with the Lautenberg Center of Immunology and Cancer Research,
Faculty of Medicine, Hebrew University of
Jerusalem, Israel and the inventor of Amilo-5MER commented
"Serum Amyloid A (SAA) initiates and activates the cascade of
events leading to chronic inflammation by stimulating release
of the pro-inflammatory cytokines IL-6,IL-1β and TNFα, generating a
"cytokine storm" and subsequently damage to the body tissues.
Amilo-5MER, specifically binds to subunits of SAA, thereby
neutralizing its pathological structure and consequently its
ability to stimulate "cytokine storm", thus interfering with the
inflammatory process. Challenged by the unmet needs of treating
inflammatory diseases and preserving the immune surveillance of
these patients, Amilo-5MER attenuates inflammation as a specific
immune modulator while not interfering with acute immune
response."
Allen Baharaff, Galmed co-founder and CEO commented: "I
congratulate Prof. Naor for the publication of his pioneering
research work on Amilo-5MER, unveiling its unique mechanism of
action. Amilo-5MER demonstrated interference with SAA
polymerization and aggregation which is essential for the activity
of SAA. Aggregated SAA is the main cause and a bio - marker of
chronic inflammation. Amilo-5MER has a unique mode of action
up stream to all pro inflammatory cytokine and can potentially be a
therapeutic agent in numerous SAA-associated pathologies."
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 developing Amilo-5MER, a 5 amino
acid synthetic peptide and recently initiated a first in human
study.
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 18, 2021, 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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