Galectin Therapeutics Announces Complete Enrollment in its Phase 2 Trial with GR-MD-02 in NASH Patients with Advanced Fibrosi...
May 11 2016 - 8:00AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins to
treat fibrosis and cancer, announces the completion of enrollment
in its Phase 2 clinical trial with GR-MD-02 in patients with
non-alcoholic steatohepatitis (NASH) with advanced fibrosis (stage
3) (the NASH-FX trial). The Company expects to report the top
line results of this trial by the end of September 2016, as
previously planned.
“We are pleased that enrollment in our NASH-FX
trial was completed right on schedule,” said Peter G. Traber, M.D.,
Galectin’s president, chief executive officer and chief medical
officer. “This is one of two Phase 2 trials we are conducting
in subjects with NASH, and is designed to assess the efficacy of
our lead compound GR-MD-02 in patients with NASH with advanced
fibrosis (stage 3). Since the diagnosis of NASH and the monitoring
of the disease are hampered by the need for liver biopsy, in
addition to providing proof-of-concept on the efficacy of GR-MD-02,
this study explores the utility of three non-invasive measures of
fibrosis which may be useful in the design and execution of later
stage clinical studies and perhaps have relevance in commercial
clinical settings.”
The NASH-FX trial has enrolled a total of 30
liver biopsy-confirmed NASH patients with advanced fibrosis (stage
3) - 15 patients to receive 8 mg/kg of GR-MD-02 and 15 patients to
receive placebo every other week for 16 weeks, for a total of nine
doses. The effect of GR-MD-02 on liver fibrosis will be assessed by
three independent non-invasive tests following the treatment
period. The primary endpoint will be an assessment of fibrosis
using multi-parametric magnetic resonance imaging
(LiverMultiScan®), which is a validated and proprietary MRI
protocol developed by Perspectum Diagnostics. Secondary endpoints
will evaluate liver stiffness, which correlates to the degree of
liver fibrosis, as assessed by magnetic resonance-elastography and
by FibroScan®. More information on the NASH-FX trial may be found
in a post on Dr. Traber’s blog, CEO Perspectives and at
www.clinicaltrials.gov.
This single-site study is being conducted by
Stephen A. Harrison, M.D., FACP, FAASLD, Colonel, Medical Corps
U.S.A., Director, Medical Education, Associate Dean, San Antonio
Uniformed Services Health Education Consortium, Professor of
Medicine, Uniformed Services University of the Health Sciences and
Consultant to The Army Surgeon General for Gastroenterological
Diseases, San Antonio Military Medical Center. Dr. Harrison
is also the co-lead investigator for Galectin’s Phase 2 NASH-CX
trial, which is studying two different doses of GR-MD-02 against
placebo in 156 patients with NASH with cirrhosis (the NASH-CX
trial).
About GR-MD-02GR-MD-02 is a
complex carbohydrate drug that targets galectin-3, a critical
protein in the pathogenesis of fatty liver disease and fibrosis.
Galectin-3 plays a major role in diseases that involve scaring of
organs including fibrotic disorders of the liver, lung, kidney,
heart and vascular system. The drug binds to galectin proteins and
disrupts their function. Preclinical data in animals have shown
that GR-MD-02 has robust treatment effects in reversing liver
fibrosis and cirrhosis.
About Fatty Liver Disease with Advanced
Fibrosis and CirrhosisNon-alcoholic steatohepatitis
(NASH), also known as fatty liver disease, has become a common
disease of the liver with the rise in obesity rates. NASH is
estimated to affect up to 28 million people in the U.S. Fatty
liver disease is characterized by the presence of fat in the liver
along with inflammation and damage in people who consume little or
no alcohol. Over time, patients with fatty liver disease can
develop fibrosis, or scarring of the liver, and it is estimated
that as many as 1-2 million individuals in the U.S. have cirrhosis,
a severe liver disease for which liver transplant is the only
treatment available. Approximately 6,300 liver transplants are
performed annually in the U.S. There are no drug therapies approved
for the treatment of NASH or liver fibrosis. A recent analyst
estimate indicated that by 2025 the worldwide market for NASH
treatments could approach $35 billion.
About Galectin
TherapeuticsGalectin Therapeutics is developing promising
carbohydrate-based therapies for the treatment of fibrotic liver
disease and cancer based on the Company's unique understanding of
galectin proteins, which are key mediators of biologic function.
Galectin seeks to leverage extensive scientific and development
expertise as well as established relationships with external
sources to achieve cost-effective and efficient development. The
Company is pursuing a development pathway to clinical enhancement
and commercialization for its lead compounds in liver fibrosis and
cancer. Additional information is available at
www.galectintherapeutics.com.
Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These statements relate to future events or future financial
performance, and use words such as “may,” “estimate,” “could,”
“expect” and others. They are based on management’s current
expectations and are subject to factors and uncertainties that
could cause actual results to differ materially from those
described in the statements. These statements include those
regarding the hope that Galectin’s development program for GR-MD-02
will lead to the first therapy for the treatment of fatty liver
disease with advanced fibrosis and/or cirrhosis and/or moderate to
severe psoriasis. Factors that could cause actual performance to
differ materially from those discussed in the forward-looking
statements include, among others, that Galectin may not be
successful in developing effective treatments and/or obtaining the
requisite approvals for the use of GR-MD-02 or any of its other
drugs in development. The Company’s current clinical trial and any
future clinical studies may not produce positive results in a
timely fashion, if at all, and could prove time consuming and
costly. Plans regarding development, approval and marketing of any
of Galectin’s drugs are subject to change at any time based on the
changing needs of the Company as determined by management and
regulatory agencies. Regardless of the results of any of its
development programs, Galectin may be unsuccessful in developing
partnerships with other companies or raising additional capital
that would allow it to further develop and/or fund any studies or
trials. Galectin has incurred operating losses since
inception, and its ability to successfully develop and market drugs
may be impacted by its ability to manage costs and finance
continuing operations. For a discussion of additional factors
impacting Galectin’s business, see the Company’s Annual Report on
Form 10-K for the year ended December 31, 2015, and subsequent
filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause
its views to change, management disclaims any obligation to update
forward-looking statements.
Contacts:Jack Callicutt, Chief Financial
Officer(678) 620-3186ir@galectintherapeutics.com
LHAKim Golodetz(212)
838-3777kgolodetz@lhai.com
Galectin Therapeutics and its associated logo is a registered
trademark of Galectin Therapeutics Inc.
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