TEL AVIV, Israel, Oct. 19, 2017 /PRNewswire/ -- Galmed
Pharmaceuticals, Inc. (Nasdaq: GLMD), a clinical-stage
biopharmaceutical company focused on the development of a
once-daily, oral therapy for the treatment of nonalcoholic
steatohepatitis, or NASH and other liver diseases, today announced
that it will host a Key Opinion Leader (KOL) meeting on NASH on
Thursday, October 26, 2017 in
New York City.
The meeting will feature a presentation by KOL Professor
Scott Friedman, MD (Icahn School of
Medicine at Mount Sinai), who will
discuss the current treatment landscape and unmet medical need for
patients with NASH. Professor Friedman will be available to
answer questions at the conclusion of the event.
Galmed's management team will also provide an overview of the
scientific rationale and ongoing clinical development program of
Aramchol™, a novel, once-daily, oral therapy for the treatment of
NASH. The Company's ARREST Phase IIb study in 248 patients is
evaluating the efficacy and safety of two Aramchol™ doses versus
placebo in patients with NASH. Top-line data is expected to be
reported in Q2 2018.
Professor Scott L. Friedman, MD
is Dean for Therapeutic Discovery and Chief of the Division of
Liver Diseases, at Icahn School of Medicine at Mount Sinai in New
York. A graduate of the Icahn School of Medicine at
Mount Sinai, Professor Friedman
served as President of Alpha Omega Alpha Honor Society and was
awarded the Arthur Aufses, Sr. Prize in Surgery. He was a Medical
Resident at Beth Israel Hospital, Harvard
Medical School, Boston, and
Gastroenterology Fellow at UCSF before assuming a 10-year faculty
position there. Recipient of many international honors, Professor
Friedman has mentored over 75 postdoctoral fellows and students,
and is listed among "America's Top Doctors." He has been a named
lecturer or Visiting Professor at more than 30 institutions
worldwide, and has authored more than 300 peer-reviewed
publications. Professor Friedman is a member of the American
Society of Clinical Investigation, Association of American
Physicians and has been elected Fellow of the American
Gastroenterological Association, American College of Physicians,
American Association for the Study of Liver Diseases (where he is
also past-president) and American Association for the Advancement
of Science. Professor Friedman is Associate Editor for the Journal
of Hepatology and Series Editor for the Mount Sinai Handbooks of
Disease, having previously been Associate Editor of Hepatology. He
has served on multiple Editorial Boards and is on the Scientific
Advisory Board of the US–Israel Binational Science Foundation. He
currently consults for over 40 pharmaceutical and biotech
companies, and is widely viewed as one of the leading experts in
fibrosis in the world.
This event is intended for institutional investors, sell-side
analysts, investment bankers, and business development
professionals only. Please RSVP in advance if you plan to attend,
as space is limited. For those who are unable to attend in
person, a live webcast will be accessible here.
About Aramchol™ and Non-alcoholic Steatohepatitis
(NASH)
Aramchol™ (arachidyl amido cholanoic acid) is a
novel fatty acid bile acid conjugate, inducing beneficial
modulation of intra-hepatic lipid metabolism. Aramchol™'s ability
to modulate hepatic lipid metabolism was discovered and validated
in animal models, demonstrating downregulation of the three key
pathologies of NASH: steatosis, inflammation and fibrosis. The
effect of Aramchol™ on fibrosis is mediated by downregulation of
steatosis and directly on human collagen producing cells. Aramchol™
has been granted Fast Track designation status by the FDA for the
treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5%
of the U.S. population and an estimated 2% to 4% globally. It is
the fastest growing cause of liver cancer and liver transplant in
the U.S. due to the rise in obesity. NASH is the progressive form
of non-alcoholic fatty liver disease that can lead to
cardiovascular disease, cirrhosis and liver-related mortality.
About Galmed Pharmaceuticals Ltd.
Galmed is a
clinical-stage biopharmaceutical company focused on the development
of Aramchol™, a first in class, novel, once-daily, oral therapy for
the treatment of NASH for variable populations, as well as other
liver associated disorders. Galmed is currently conducting the
ARREST Study, a multicenter, randomized, double blind,
placebo-controlled Phase IIb clinical study designed to evaluate
the efficacy and safety of Aramchol™ in subjects with NASH, who are
overweight or obese, and who are pre-diabetic or type-II-diabetic.
Galmed also sponsors the ARRIVE Study, a proof-of-concept Phase IIa
clinical trial designed to evaluate the safety and efficacy of
Aramchol™ in up to 50 patients with HIV-associated NAFLD and
lipodystrophy. The ARRIVE Study is an investigator-initiated trial,
conducted at the University of California San
Diego by Professor Rohit
Loomba. More information about the ARREST Study and the
ARRIVE Study may be found on ClinicalTrials.gov identifiers:
NCT02279524 and NCT02684591, respectively.
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 ongoing
Phase IIb ARREST Study, and planned Phase III trials for Aramchol™,
or whether Phase III trials will be conducted at all; completion
and receiving favorable results of these Phase IIb ARREST Study and
Phase III trials for Aramchol™; 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 in patients who are
overweight or obese and have pre diabetes or type II diabetes
mellitus; 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 23, 2017, 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.
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SOURCE Galmed Pharmaceuticals, Inc