The clinical research and development program will be conducted
in collaboration with the Stravitz–Sanyal Institute for Liver
Disease and Metabolic Health Virginia
Commonwealth University.
TEL
AVIV, Israel, May 9, 2023
/PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD)
("Galmed" or the "Company"), a clinical-stage biopharmaceutical
company for liver, metabolic and fibrotic diseases, today announced
the initiation of a new clinical program to evaluate its lead
compound, Aramchol meglumine for the Treatment of Primary
Sclerosing Cholangitis (PSC).
PSC is a chronic cholestatic liver disease, characterized by
progressive and multifocal fibrosis of the biliary system, which
typically results in cirrhosis and fibrotic liver disease. It is a
rare disease with no approved treatment that qualifies for the
status of an orphan disease in the United
States and EU; it is estimated that ~70% of the PSC patients
have underlying IBD, most frequently ulcerative colitis (UC).
Galmed plans to initiate a Phase 2 study in the last quarter of
2023. The single-arm, open label, proof-of-concept clinical trial
will evaluate the effects of 24 weeks of treatment with Aramchol
meglumine in approximately 15 patients with PSC. The study's
endpoints will include the conventional relevant laboratory
parameters (alkaline phosphatase and bilirubin), sophisticated
imaging including liver stiffness using MR Elastography (MRE),
imaging of the biliary tract using MR cholangiopancreatography
(MRCP) and hepatocyte-specific contrast agents, histological
fibrosis and molecular assessment as well as a range of biomarkers
of disease activity and fibrosis. These endpoints are expected to
provide a robust assessment of the underlying disease and the
effects of Aramchol.
Notably most patients in the study are expected to suffer also
from UC. Building on the strong rationale and pre-clinical data
supporting the use of Aramchol in IBD, the study will also assess
the status of UC, inflammatory markers and patients related
outcomes (PROs).
The study will be conducted at the Stravitz–Sanyal Institute for
Liver Disease and Metabolic Health Virginia
Commonwealth University with Dr. Sayed Obaidullah Aseem as Principal
Investigator.
Prof. Arun Sanyal, Director,
Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at
VCU commented "there is a great unmet need for development of
effective therapeutics for primary sclerosing cholangitis.
This proof-of-concept study should provide insights into the
translatability of the strong preclinical data on the utility of
Aramchol on cholestasis-related fibrosis in humans with PSC and we
are excited to test this new metabolically driven therapeutic
approach for PSC."
Dr. Sayed Obaidullah Aseem
commented "Aramchol has sound scientific rationale for use in
fibrotic liver diseases. We are finding additional supportive data
in pre-clinical models of PSC and cholestasis. Our initial clinical
study will use state of the art modalities in addition to commonly
used disease markers to develop the foundation for larger trials in
PSC. This is an exciting opportunity in figuring out a treatment
for PSC patients who currently do not have any effective options.
"
Allen Baharaff, CEO and President of Galmed Pharmaceuticals
commented "Looking at the significant anti fibrotic effects of
Aramchol in the liver and the robust scientific rationale to use
this compound for other fibrotic liver indications, we believe
Aramchol has a promising clinical potential in patients with
primary sclerosing cholangitis as well as for IBD. We look forward
to the first clinical data during 2024 to further guide future
development of Aramchol"
About Primary Sclerosing Cholangitis (PSC)
PSC is a rare chronic cholestatic liver disease characterized by
fibroinflammatory destruction of the intrahepatic and/or
extrahepatic bile ducts, leading to bile stasis, fibrosis, and
ultimately to cirrhosis, and often requires liver
transplantation.
PSC occurs more commonly in men and is typically diagnosed
between the ages of 30 and 40. Most cases occur in association with
inflammatory bowel disease (IBD).
The etiology of PSC is poorly understood, but an increasing body
of evidence supports the concept of cholangiocyte injury as a
result of environmental exposure and an abnormal immune response in
genetically susceptible individuals.
Growing body of evidence suggests several treatment modalities
mainly focusing on the inflammation aspect of this disorder, yet no
effective therapy is available for halting disease progression.
Learn more about PSC at
https://www.niddk.nih.gov/health-information/liver-disease/primary-sclerosing-cholangitis/definition-facts
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of
Aramchol. Historically, we have focused almost exclusively on
developing Aramchol for the treatment 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. 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, our ability to identify, evaluate and complete any
strategic alternative that yields value for our shareholders; the
timing and cost of our 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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