TEL AVIV, Israel, Jan. 10, 2022 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company for liver, metabolic and
inflammatory diseases announced today results of a Phase 1 clinical
trial of Amilo-5MER in healthy volunteers that demonstrated an
excellent safety profile and tolerability.
Amilo-5MER is a synthetic peptide consisting of 5 amino acids
that significantly reduces symptoms and histopathological hallmarks
of IBD in animal models (TNBS, DSS). TNBS and DSS are
well-established and widely recognized models of acute colitis.
Amilo-5MER also showed anti-inflammatory effects in animal models
of multiple sclerosis and rheumatoid arthritis. Amilo-5MER exerts
its anti-inflammatory effects by binding with high affinity to
pro-inflammatory amyloid proteins, preventing polymerization of
Serum Amyloid A (SAA) monomers and thereby interfering with
SAA-induced immune cell activation.
The safety, tolerability, and pharmacokinetics of single and
multiple doses of Amilo-5MER were assessed in a first-in-human
study in healthy subjects. The Phase I study was conducted in
a single-center, using a double-blind, randomized,
placebo-controlled design. Overall, 64 healthy male and female
subjects were enrolled in the study. Cohorts of 8 subjects were
randomized to receive Amilo-5MER or placebo by subcutaneous
injection in a ratio of 6:2. In Part 1, cohorts of young male
adults received single ascending doses of 10, 30, 90, 180 and 360
mg; in Part 2, a single cohort received doses of 180 mg BID for 5
consecutive days and in Part 3 a single cohort of healthy elderly
male and female subjects received a single dose of
All doses of Amilo-5MER were well tolerated with no clinically
significant adverse events and none considered related to the
investigational product. All subjects completed the study as
per protocol. Plasma concentrations of Amilo-5MER increased
in proportion to dose.
Prof John Posner Visiting Professor, School of Life Sciences
& Medicine, King's College London who served as medical monitor
commented, "Serum Amyloid A is an important inducer of inflammation
and Amilo-5MER has real potential to serve as a first in class,
specific anti-inflammatory agent with multiple disease
indications. It also has the potential to inhibit cytokine
"We are excited to bring Amilo-5MER into the clinical phase and
look forward to advancing our product pipeline to address
additional important indications for the benefit of patients around
the world," noted Allen Baharaff, President and CEO of Galmed.
Galmed is developing Amilo-5MER for multiple routes of
administration and multiple indications. The Company plans to
submit an IND for mild to moderate ulcerative colitis in 2022.
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 collaborating with the
Hebrew University in the development of
Amilo-5MER, a 5 amino acid synthetic peptide.
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.
SOURCE Galmed Pharmaceuticals Ltd.