TEL
AVIV, Israel, March 15,
2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage
biopharmaceutical company for liver, metabolic and fibrotic
diseases announced today the grant of a European patent related to
the use of a combination of Aramchol and Resmetirom (MGL-3196,
REZDIFFRA) for the treatment of NASH/MASH and liver fibrosis. The
patent was granted in France,
Germany, Italy, the
Netherlands and the United
Kingdom and the approval of the patent in the United States and other countries is
pending. With this latest patent, Galmed is strengthening and
extending the patent protection of its lead compound, Aramchol,
until September 2039.
Previously, Galmed reported results from the Open-Label part of
its Phase 3 NASH study, which demonstrated that treatment with
Aramchol 300mg BID resulted in a high rate of subjects with
fibrosis improvement.
https://galmedpharma.investorroom.com/2022-04-28-Galmed-reports-interim-results-from-the-Open-Label-part-of-the-ARMOR-study-with-Aramchol-showing-robust-fibrosis-improvement-across-multimodality-histological-assessment
Galmed has long believed that the optimum treatment for
NASH/MASH will be combination therapy. Aramchol has been shown to
down-regulate the expression and activity of stearoyl-CoA
desaturase-1 (SCD1) in hepatic stellate cells, resulting in a
direct effect on fibrogenesis. Aramchol's unique mechanism of
action differs from others in its competitive landscape,
positioning it to work as a potent anti-fibrotic compound alongside
effective treatments in both approved and pre-approval stages.
Allen Baharaff, CEO and President of Galmed Pharmaceuticals
mentioned that "this new patent for the combination of Aramchol and
Resmetirom reflects the same spirit of earlier patents which were
granted to Galmed by the United States Patent and Trademark
Office (USPTO) for the treatment for hepatic fibrosis." Mr.
Baharaff continued "It is clear today that NASH is a chronic
condition with multiple liver pathologies. Among all
pathologies,
excessive liver fat, high glycemic index and fibrosis are major
treatment challenges. By combining Aramchol and Resmetirom, two
distinct and selective compounds with complementary mechanisms, we
believe this will provide a perfect treatment for NASH."
About Galmed Pharmaceuticals Ltd.
We are a clinical stage biopharmaceutical company focused on the
development of Aramchol for liver and fibro-inflammatory diseases.
We have focused almost exclusively on developing Aramchol for the
treatment of NASH and are currently developing Aramchol for PSC and
exploring the feasibility of developing Aramchol for other
fibro-inflammatory indications outside of liver disease. We are
also collaborating with the Hebrew
University in the development of Amilo-5MER, a 5 amino acid
synthetic peptide.
Forward-Looking Statements:
Forward-looking statements relate to anticipated or expected
events, activities, trends or results as of the date they are made.
Because forward-looking statements relate to matters that have not
yet occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the
forward-looking statements. Forward-looking statements may include,
but are not limited to, statements relating to our objectives plans
and strategies, as well as statements, other than historical facts,
that address activities, events or developments that we intend,
expect, project, believesor anticipate will or may occur in the
future. Many factors could cause our actual activities or
results to differ materially from the activities and results
anticipated in forward-looking statements, including, but not
limited to, the timing and cost of any pre-clinical or clinical
trial, for our product candidates; completion and receiving
favorable results of any pre-clinical or clinical trial; regulatory
action with respect to Aramchol or any other product candidate by
the U.S. Food and Drug Administration, or the FDA, or the European
Medicines Authority, or EMA, including but not limited to
acceptance of an application for marketing authorization, review
and approval of such application, and, if approved, the scope of
the approved indication and labeling; the commercial launch and
future sales of Aramchol and any future product candidates; our
ability to comply with all applicable post-market regulatory
requirements for Aramchol or any other product candidate in the
countries in which we seek to market the product; our ability to
achieve favorable pricing for Aramchol or any other product
candidate; our expectations regarding the commercial market for
non-alcoholic steato-hepatitis, or NASH, in patients or any other
targeted indication; third-party payor reimbursement for Aramchol
or any other product candidate; our estimates regarding anticipated
capital requirements and our 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; our ability to
obtain and maintain adequate protection of our intellectual
property; the possibility that we may face third-party claims of
intellectual property infringement; our ability to manufacture our
product candidates in commercial quantities, at an adequate quality
or at an acceptable cost; our ability to establish adequate sales,
marketing and distribution channels; intense competition in our
industry, with competitors having substantially greater financial,
technological, research and development, regulatory and clinical,
manufacturing, marketing and sales, distribution and personnel
resources than we do; the development and approval of the use of
Aramchol or any other product candidate for additional indications
or in combination therapy; our ability to maintain the listing of
our ordinary share on The Nasdaq Capital Market; and our
expectations regarding licensing, acquisitions and strategic
operations. We believe these forward-looking statements are
reasonable; however, these statements are only current predictions
and are subject to known and unknown risks, uncertainties and other
factors that may cause our or our industry's actual results, levels
of activity, performance or achievements to be materially different
from those anticipated by the forward-looking statements. We
discuss many of these risks in our Annual Report on Form 20-F for
the year ended December 31, 2022
filed with the SEC on March 29, 2023
in greater detail under the heading "Risk Factors." Given these
uncertainties, you should not rely upon forward-looking statements
as predictions of future events. All forward-looking statements
attributable to us or persons acting on our behalf speak only as of
the date hereof and are expressly qualified in their entirety by
the cautionary statements included in this report. We undertake no
obligations to update or revise forward-looking statements to
reflect events or circumstances that arise after the date made or
to reflect the occurrence of unanticipated events. In evaluating
forward-looking statements, you should consider these risks and
uncertainties.
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SOURCE Galmed Pharmaceuticals Ltd.
