TEL
AVIV, Israel, Nov. 20,
2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage
biopharmaceutical company for liver, metabolic and fibrotic
diseases, announced today a delay of at least 6 months in the
initiation of its Primary Sclerosing Cholangitis (PSC) Ph 2a
Study.
In May 2023, Galmed announced the
pivoting of its clinical program to evaluate the safety and
efficacy of its lead compound, Aramchol meglumine, for the
treatment PSC. All work was designed to ensure the initiation of a
proof-of-concept Phase 2a study in the last quarter of 2023. Prior
to the initiation of the Ph 2a study, Galmed had planned to
complete a Ph1 pharmacokinetic (PK) study to determine the
bioavailability of the newly improved Aramchol meglumine
formulation and then submit a new IND application for Aramchol
meglumine for PSC to the US FDA.
Due to the unexpected events of October
7th, Galmed no longer will be able to meet the original
planned timelines of its Ph1 study. As new time estimates depend on
timelines established by our US and European partners and vendors,
Galmed currently estimates a delay of 6-9 months in the initiation
of the Ph2a PSC Study.
Allen Baharaff, CEO and President of Galmed Pharmaceuticals
commented " The brutal attack of Hamas on October 7th resulted in a disruption
of our work. Notwithstanding the Israel's declaration of "being at war",
over the past few weeks we have been returning to full activity
together with our local vendors and consultants. The unfortunate
events result in delays which would prohibit us from meeting our
original timelines. We are diligently working together with our
local and international partners to mitigate the delays and will
continue to update as soon as practical".
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. 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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SOURCE Galmed Pharmaceuticals Ltd.
