TEL AVIV, Israel, Oct. 31, 2019 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of Aramchol, a liver targeted, oral, SCD1 modulator, currently in
Phase 3/4 clinical trial for the treatment of nonalcoholic
steatohepatitis (NASH) and fibrosis announced today that it will
present new data at The Liver Meeting®, the annual meeting of the
American Association for the Study of Liver Diseases (AASLD) in
Boston, November 8-12, 2019. This new pre-clinical data
elucidates the mechanism by which Aramchol affects glucose
metabolism in the liver that resulted in a reduction of HbA1C in
patients in the Company's Phase IIb trial. The data suggests that
Aramchol improves liver glucose homeostasis in patients and murine
models. Galmed will also present clinical data on the rationale for
the Phase 3/4 dose selection and its potential increased
efficacy.
"At this year's Liver Meeting, we look forward to sharing new
mechanistic data that will emphasize the role of Aramchol in the
disease progression, treating multiple aspects of NASH including
also normalization of glucose metabolism. These new data are
particularly important for the patients enrolling in our ongoing
ARMOR Phase 3/4 study who are overweight/obese and have
prediabetes/diabetes," stated Allen Baharaff, Chief Executive
Officer of Galmed. "In addition, the clinical data we are
presenting demonstrated a significant increase in exposure
following twice daily treatment, potentially increasing
efficacy."
Galmed will be exhibiting at booth #602 througout the The Liver
Meeting®.
The following posters will be presented during The Liver
Meeting® as a part of Session: NAFLD and NASH: Experimental
Clinical
Monday, November 11, 2019 –
08:00 a.m. – 05:30 p,m, ET
"Aramchol, SCD1 inhibitor, improves liver glucose homeostasis
in NASH" (Abstract #2304)
Laura de laCruz-Villar, David Fernández-Ramos,
Fernando Lopitz-Otsoa, Marta Iruarrizaga-Lejarreta, Jon Bilbao, Diana
Cabrera, Sebastiaan M van Liempd1,
Cristina Alonso, Shelly C Lu, Liat
Hayardeny, Tali Gorfine, José M. Mato
"Increased exposure of Aramchol by using a split dose –
potential for greater efficacy in NASH" (Abstract #2326)
Graham Trevitt, Richard Weaver, John
Posner, Liat Hayardeny, Tal
Gorfine, Shaul Kadosh
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Our lead compound, Aramchol™, a backbone drug candidate
for the treatment of NASH and fibrosis is currently in a Phase 3/4
registrational study.
Forward-Looking Statements:
This press release may include forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to Galmed's objectives, plans and strategies,
as well as statements, other than historical facts, that address
activities, events or developments that Galmed intends, expects,
projects, believes or anticipates will or may occur in the future.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements. Many factors could cause Galmed's actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, the following: the timing and cost of Galmed's
planned pivotal Phase 3/4 ARMOR trial, or the ARMOR Study or
whether a pivotal trial will be conducted at all; completion and
receiving favorable results of the ARMOR Study for Aramchol or any
other pre-clinical or clinical trial; regulatory action with
respect to Aramchol by the FDA or the EMA; the commercial launch
and future sales of Aramchol or any other future products or
product candidates; Galmed's ability to comply with all applicable
post-market regulatory requirements for Aramchol in the countries
in which it seeks to market the product; Galmed's ability to
achieve favorable pricing for Aramchol; Galmed's expectations
regarding the commercial market for NASH patients; third-party
payor reimbursement for Aramchol; Galmed's estimates regarding
anticipated capital requirements and Galmed's needs for additional
financing; market adoption of Aramchol by physicians and patients;
the timing, cost or other aspects of the commercial launch of
Aramchol; the development and approval of the use of Aramchol for
additional indications or in combination therapy; and Galmed's
expectations regarding licensing, acquisitions and strategic
operations. More detailed information about the risks and
uncertainties affecting Galmed is contained under the heading "Risk
Factors" included in Galmed's most recent Annual Report on Form
20-F filed with the SEC on March 13,
2019, and in other filings that Galmed has made and may make
with the SEC in the future. The forward-looking statements
contained in this press release are made as of the date of this
press release and reflect Galmed's current views with respect to
future events, and Galmed does not undertake and specifically
disclaims any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Logo -
https://mma.prnewswire.com/media/595923/Galmed_Pharmaceuticals_Ltd_Logo.jpg
View original
content:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-to-present-new-data-on-aramchol-effect-on-glucose-metabolism-moa-and-clinical-results-at-aasld-2019-300949020.html
SOURCE Galmed Pharmaceuticals Ltd.