TEL AVIV, Israel, Jan. 11, 2022 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (NASDAQ-CM: GLMD) ("Galmed" or the "Company"),
a clinical-stage biopharmaceutical company for liver, metabolic and
inflammatory diseases announced today that the United States Patent
and Trademark Office (USPTO) granted Galmed new patents related to
the use of Aramchol for the treatment of fibrosis and for the
treatment for modulating gut microbiota. An additional patent grant
protects the low dose composition of Aramchol salt until
June 8, 2036. With these latest
patents, Galmed is strengthening and extending the IP protection of
its lead compound, Aramchol, until December
2038.
The three new patents relate to:
- The grant of a US patent (US 11,197,870 B2, expiring
October 20, 2037) claims the use of
Aramchol or salts thereof (e.g. Aramchol Meglumine) for the
treatment of hepatic fibrosis. The patent supports the direct anti
fibrotic effect of Aramchol in liver, where the hepatic fibrosis is
not associated with NAFLD or NASH.
- The grant of a US patent (US 11,166,964 B2), directed to the
use of Aramchol or salts thereof (e.g. Aramchol Meglumine) for the
treatment of dysbiosis of the gastrointestinal (GI) tract opens
potential new treatment modalities for Aramchol in GI pathology and
extends Galmed's proprietary Aramchol Meglumine patent protection
until December 1, 2038.
- The grant of a US patent (US 10,849,911 B2) for low dose
composition of Aramchol salt extends Aramchol intellectual property
protection until June 8, 2036,
claiming a salt of Aramchol, including the Meglumine Salt, as a
composition of matter and for the treatment of NAFLD and NASH.
"The past 12 months have been an exciting time for Galmed as we
reported positive, interim data from the Open Label part of our
Phase 3 ARMOR clinical trial for the treatment of NASH and
fibrosis. As such, we are delighted that these newly granted
patents help secure broad IP rights underpinning Aramchol and its
salts. We believe the granting of these patents provides us the
necessary protection to expand our clinical development program,"
noted Allen Baharaff, President and CEO of Galmed.
Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Their 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.
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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SOURCE Galmed Pharmaceuticals Ltd.