- The paper re-iterates the significant anti-fibrotic effect
of Aramchol 300mg BID in patients with metabolic dysfunction
associated steatohepatitis (MASH)
- Data is confirmed using 3 objective measurements;
NASH CRN, paired ranked reading, and Artificial Intelligence
(AI) quantitative digital analysis
- Continuous histological fibrosis scores generated in
antifibrotic trials by digital pathology images analysis (DIA)
quantify antifibrotic effects with greater sensitivity and larger
dynamic range than Conventional Pathology
TEL
AVIV, Israel, Sept. 25,
2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage
biopharmaceutical company for liver, metabolic and
fibro-inflammatory diseases announced today that the one-year
results of the Open-Label part (ARCON ) of its global Phase 3 trial
of Aramchol in 150 patients with NASH and fibrosis (ARMOR) have
been published in Hepatology.
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
histological fibrosis improvement.
Aramchol is the most advanced down regulator of SCD-1 (Stearoyl
– CoA desaturase) in clinical development. Inhibition of SCD-1 has
been recently investigated in multiple indications, re-emphasizing
its metabolic master switch potential and importance in multiple
organs and activities. Aramchol, by targeting this single receptor,
induces a cascade of events that leads to two main changes; in
hepatocytes, Aramchol elevates the fatty acids oxidation (or in
other words – fat burn) and influences AMPK, which results also in
reducing glycemic parameters; and in hepatic stellate cells,
Aramchol has been shown to down-regulate the expression and
activity of stearoyl-CoA desaturase-1 (SCD-1), resulting in a
direct effect on fibrogenesis.
Galmed has long believed that the optimum treatment for MASH
will be combination therapy. The company further believes that
Aramchol' s unique mechanism of action differentiates itself from
others in the competitive landscape, potentially positioning it to
work as a potent anti-fibrotic compound alongside effective
treatments in both approved and pre-approval stages.
Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université,
the paper's lead author and the ARMOR study co-principal
investigator commented: "The publication of the results of the
ARCON cohort in a prestigious medical journal such as Hepatology
speaks to the interest of the scientific community towards this
molecule with an innovative mode of action and its potential for
treating fibrotic MASH. The rigorous multimodality histology
assessment, using both conventional and FibroNest™ AI digital
pathology (PharmaNest Inc, Princeton,
USA), allowed us to see that the
drug was working and identify changes of regression as well as
affirming and extending findings of the AI Digital Pathology
analysis that is relevant to all MASH studies."
"The publication in Hepatology highlights the significant
potential of Aramchol as a therapeutic option for patients
diagnosed with MASH and Fibrosis. We are grateful to all the
patients and clinical sites that participated in the study around
the world. Our sincere thanks to Prof. Vlad Ratziu, Prof.
Arun Sanyal the study co-PIs, and
Prof. Scott Friedman for their
fruitful scientific and clinical guidance. We also extend our
gratitude to Prof. Carolin Lackner,
Prof. Cynthia Behling and Prof.
William Cummings, the study
pathologists for their meticulous reading and interest in exploring
the benefits of Digital Pathology and Artificial intelligence in
the context of MASH clinical trials", said Allen Baharaff,
President and Chief Executive Officer of Galmed.
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of
Aramchol. We have focused almost exclusively on developing Aramchol
for the treatment of liver disease and have been developing
Aramchol for PSC and exploring the feasibility of developing
Aramchol for other fibroinflammatory and oncological indications
outside of liver disease. We are also collaborating with the
Hebrew University in the development of
Amilo5MER, 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, believes or 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, 2023
filed with the SEC on April 4, 2024
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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