- Aramchol is the most clinically advanced, first-in-class,
Stearoyl-CoA desaturase1 (SCD1) oral inhibitor, demonstrating in
Ph2 and Ph3 (open label part) an excellent safety profile with
metabolic and anti-fibrotic effects.
- Galmed raised an aggregate of $7.5
million in warrant exercises and drawdowns on
its recently adopted equity line
TEL
AVIV, Israel, Sept. 19,
2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage
biopharmaceutical company for fibroinflammatory indications
announced today that based on the recently published results from
the Open-Label part of its Phase 3 NASH study, new scientific
publications on the role of SCD1 as a critical metabolic signaling
hub as well as an extended cash runway, it plans to broaden its
drug development activities.
The planned expansion consists of two additional programs over
the next two years. One program aims to identify novel
Aramchol-based drug combinations to overcome resistance to
standard-of-care oncological treatments for patients with advanced
colorectal and hepatic cancers. Another program aims to unravel new
mechanisms of action that will allow the development of a novel
Aramchol-based drug combination targeting cardiac fibrosis, or
scarring of the heart, which occurs in many cardiovascular diseases
that can lead to heart dysfunction and failure. The Company plans
on releasing new data from in-vitro and ex-vivo studies in these
programs during the fourth quarter of 2024.
Recent scientific publications reveal that:
-
- SCD1 inhibition emerges as a novel therapeutic strategy
for clinically important cardiometabolic diseases
which affect more than 60 million people in the United States alone.
- The combination of SCD1 inhibitor with standard-of-care
oncology agents has the potential of the prevention of drug
resistance thus ameliorating the prognosis of patients with
hepatoma (hepatocellular carcinoma,
HCC), colorectal cancer and glioma
(GBM).
- The newly discovered link between lipid metabolism and
synucleinopathies (Parkinson disease and some forms of
dementia) provides validation of SCD inhibition as
a neuroprotective treatment.
Allen Baharaff, President and CEO of Galmed Pharmaceuticals
commented: "The conditions Galmed plans to focus upon in the
coming years are major public health problems impacting millions of
people worldwide and posing huge financial burden on health
providers. SCD1 is a key enzyme that critically regulates many
physiological processes, thereby promoting the progression of
cardiovascular, cancer and neurodegenerative diseases. We are
leveraging on two decades of development of the most clinically
advanced SCD1 inhibitor (Aramchol) to date as we broaden our drug
development activities. Recent scientific breakthroughs identifying
the role of SCD1 as a "master-switch" in lipid metabolism together
with our recent infusion of cash, encourage us to expand from liver
diseases to major cardiometabolic and cancer indications in dire
need of new therapies. In this research, Galmed is collaborating
with both leading academia and industry, employing cutting-edge
drug development methodologies like AI data mining and proprietary
"organ-on-a-chip" systems to accelerate our development processes."
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of
Aramchol. We have focused 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.
Logo: https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/galmed-announces-an-expansion-of-its-activities-to-cancer-and-major-cardiometabolic-diseases-302252949.html
SOURCE Galmed Pharmaceuticals Ltd.