Galectin Therapeutics Announces Important Milestones towards Completion of NASH CX Trial
June 13 2017 - 8:30AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins to
treat fibrosis, skin disease, and cancer, announces the independent
data safety monitoring board (DSMB) recently concluded that, from a
safety perspective, the Company’s NASH-CX trial should continue.
This was the third time the DSMB met to evaluate the NASH-CX trial,
all concluding with a positive review of the Company’s safety
results and overall conduct of the trial. As of the time of their
evaluation, therapy had been completed in 68% of subjects in the
NASH-CX trial. The Company expects to report the topline results of
this trial in December 2017, as previously announced.
The DSMB is a panel of experts not affiliated
with the Company nor involved in the conduct of the trial who are
tasked with monitoring the safety of subjects enrolled. The panel
recently met to review safety data of all enrolled subjects who had
completed the trial. The feedback from the committee to the Company
was positive. First, the experts concluded that there were no
safety concerns and that the clinical trial should continue as per
the protocol. Second, in reviewing the drug levels in subjects,
there were no issues noted and the results appeared consistent
across all subjects. Finally, the panel congratulated the company
for a trial that has run so smoothly.
“We are pleased that the independent DSMB has
determined that our NASH-CX trial is being conducted in a safe,
consistent and efficient manner,” said Peter G. Traber, M.D.,
Galectin’s president, chief executive officer and chief medical
officer. “This phase 2b clinical trial is designed to assess the
efficacy of our lead compound GR-MD-02 in patients with NASH
cirrhosis. This trial was designed and is being conducted with a
primary endpoint that the U.S. Food and Drug Administration views
may be a surrogate for outcomes for registration trials in this
patient population.”
The NASH-CX trial enrolled 162 biopsy-confirmed
NASH cirrhosis patients into the treatment phase and, after only 11
subjects dropped out of the study, there are 151 potential patients
completing the trial. Enrolled patients are receiving either 8
mg/kg or 2 mg/kg of GR-MD-02 or placebo every other week for 52
weeks, for a total of 26 infusions.
The primary study endpoint is a reduction in
hepatic venous pressure gradient (HVPG), which is a measure of
portal pressure and is correlated with patient outcome in this
patient population. Patients treated with GR-MD-02 will be
evaluated to determine the change in HVPG as compared to patients
treated with placebo. Key secondary endpoints include liver biopsy
with qualitative fibrosis staging and fibrosis quantification,
measurement of liver stiffness (FibroScan(R)), and assessment of
liver metabolism (13C-methacetin breath test, Exalenz), as well as
multiple serum biomarkers of fibrosis. More information on the
NASH-CX trial may be found in a post on Dr. Traber’s blog, CEO
Perspectives and at www.clinicaltrials.gov.
“NASH cirrhosis, and indeed all causes of
cirrhosis, represent a large unmet medical need with no currently
approved medical therapies,” said Dr. Traber. “A drug that can halt
progression of, or reverse existing fibrosis, in NASH cirrhosis
patients would be a breakthrough therapeutic intervention that may
prevent complications, alleviate the need for liver transplant, and
even prevent death. While progression to cirrhosis in NASH is not
common, the enormous number of people with fatty liver disease
globally suggests that nearly 20 million people currently with
fatty liver disease across the world may die of their disease. Read
more about the global scope of this problem in my CEO
Perspective.”
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 scarring 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 fatty liver disease
(NAFLD) has become the most common disease of the liver, generally
associated with the rise in obesity rates. NAFLD is
characterized by the presence of fat in the liver in people who
consume little or no alcohol, and when associated with inflammation
and cell damage is called non-alcoholic steatohepatitis (NASH).
Over time, patients with NASH can develop fibrosis, or scarring of
the liver, which may progress to severe fibrosis, called cirrhosis.
Approximately one in four people in the world have NAFLD, with 5%
of those developing cirrhosis, and 2% eventually dying of the
disease. These data translate into ~20,000,000 liver-related deaths
among patients currently alive with NAFLD. There are no drug
therapies approved for the treatment of NASH, liver fibrosis, or
cirrhosis, for which liver transplant is the only treatment
available. 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. 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 complete or 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, 2016, 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.
Galectin Therapeutics and its associated logo is a registered
trademark of Galectin Therapeutics Inc.
Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
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