Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
today announced the launch of NAVIGATEnash.com, its dedicated trial
website. The new website intends to educate patients and physicians
about liver cirrhosis resulting from non-alcoholic steatohepatitis
(NASH) as well as support NAVIGATE, the Company’s innovative,
seamless adaptive Phase 2b/3 study in NASH cirrhosis.
There is currently no
treatment to stop the progression and more serious complications of
NASH cirrhosis. The NAVIGATE Study is offering patients and their
families an opportunity to contribute to the development of the
first potential therapy targeted specifically at NASH cirrhosis and
designed to improve clinical outcomes.
“Discussions in our broad
community tend to focus on investment and intervention in early
stages of NASH, with little attention given to patients who have
progressed to NASH cirrhosis. However, since assuming my role in
September, I have been moved by the determination of this
overlooked patient community and the physicians who treat them.
Both deserve dedication and investment in finding a meaningful
treatment,” said Joel Lewis, Chief Executive Officer and President
of Galectin Therapeutics. “NAVIGATEnash.com is not only meant to
engage this important community – who may be looking to participate
in NAVIGATE – and inform others about NASH cirrhosis, it is
intended to send a message to a much broader community that we are
willing to overcome the largest challenge in this space.”
“NASH is quickly becoming
the number one cause of liver cirrhosis. Unfortunately, the only
treatment option for patients who progress to NASH cirrhosis is a
liver transplant, something we, at Galectin Therapeutics, hope to
change,” said Pol F. Boudes M.D., Chief Medical Officer of Galectin
Therapeutics. “We want to provide the necessary information to
patients and physicians about our study, since, unlike other
clinical trials in NASH, NAVIGATE specifically targets the
prevention of a potentially life-threatening manifestation of NASH
cirrhosis.”
NAVIGATEnash.com is
designed to educate patients, their families, and friends on the
causes and potential complications of NASH cirrhosis. The site
provides resources for additional information, details about
NAVIGATE, and how, potentially, to participate. A “For Physicians”
section provides physicians information on NASH cirrhosis and
guidance on whether participating or referring patients to NAVIGATE
might be appropriate.
The goal of the NAVIGATE
Study is to prevent the development of esophageal varices, thought
to be an early sign of more serious complications of NASH
cirrhosis. Bleeding esophageal varices are a cause of death in
about one-third of cirrhotic patients. An earlier clinical trial
showed that belapectin, a galectin-3 inhibitor, may prevent the
development of esophageal varices in patients with compensated NASH
cirrhosis and was well tolerated and appeared safe.
About NASH
Cirrhosis
NASH cirrhosis is the end
stage of non-alcoholic steatohepatitis (NASH), which is
characterized by the presence of excess fat in the liver. Over
time, scar tissue and regenerative nodules resulting from the
inflammation and fibrosis of NASH replace healthy liver tissue,
preventing the liver from functioning normally. Over 28 million
people in the U.S. are thought to suffer from NASH, and an
estimated 1 to 2 million of them will eventually progress to NASH
cirrhosis. NASH cirrhosis will soon become the number one reason
for liver transplants.
About Belapectin
(GR-MD-02)
Belapectin (GR-MD-02) is
a complex carbohydrate drug that targets galectin-3, a critical
protein in the pathogenesis of NASH 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. Belapectin binds to galectin-3 and disrupts its function.
Preclinical data in animals have shown that belapectin has robust
treatment effects in reversing liver fibrosis and cirrhosis. A
Phase 2 study showed belapectin may prevent the development of
esophageal varices in NASH cirrhosis. Galectin-3 also has a
significant role in cancer, and the Company is supporting a Phase 1
study in combined immunotherapy of belapectin and Keytruda® in
treatment of advanced melanoma and in head and neck cancer.
About the
NAVIGATE Study
The NAVIGATE Study
(originally named the NASH-RX trial) is an international, seamless,
adaptively-designed Phase 2b/3 trial of the galectin-3 inhibitor
belapectin (GR-MD-02), the company's lead compound, in NASH
cirrhosis patients who have clinical signs of portal hypertension
and are at risk of developing esophageal varices. Belapectin had
previously been shown that it could prevent the development of new
varices in this patient population. The NAVIGATE Study is expected
to enroll approximately 315 NASH patients in the Phase 2b part of
the trial at approximately 130 sites in 12 countries in North
America, Europe, Asia and Australia. After 18 months of treatment,
an interim analysis will be conducted to determine the optimum
dosage of belapectin, and the NAVIGATE Study will move into Phase 3
with additional patients for another 18 months of treatment.
More information on the
NAVIGATE Study can be found at NAVIGATEnash.com.
About Galectin
Therapeutics
Galectin Therapeutics is
dedicated to developing novel therapies to improve the lives of
patients with chronic liver disease and cancer. Galectin’s lead
drug belapectin (formerly known as GR-MD-02) is a
carbohydrate-based drug that inhibits the galectin-3 protein which
is directly involved in multiple inflammatory, fibrotic, and
malignant diseases, for which it has Fast Track designation by the
U.S. Food and Drug Administration. The lead development program is
in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most
advanced form of NASH-related fibrosis. This is the most common
liver disease and one of the largest drug development opportunities
available today. Additional development programs are in treatment
of combination immunotherapy for advanced melanoma and other
malignancies. Advancement of these additional clinical programs is
largely dependent on finding a suitable partner. Galectin seeks to
leverage extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. Additional information is
available at www.galectintherapeutics.com.
Forward Looking
Statements
This 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 belapectin will lead to the first therapy for the
treatment of fatty liver disease with cirrhosis and those regarding
the hope that our lead compounds will be successful in cancer
immunotherapy and in other therapeutic indications. Factors that
could cause actual performance to differ materially from those
discussed in the forward-looking statements include, among others,
that trial endpoints required by the FDA may not be achieved;
Galectin may not be successful in developing effective treatments
and/or obtaining the requisite approvals for the use of belapectin
or any of its other drugs in development; the Company may not be
successful in scaling up manufacturing and meeting requirements
related to chemistry, manufacturing and control matters; the
Company’s current NAVIGATE clinical trial and any future clinical
studies as modified to meet the requirements of the FDA may not
produce positive results in a timely fashion, if at all, and could
require larger and longer trials, which would be 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. Global factors such as COVID-19 may limit access to
NASH patient populations around the globe and slow trial enrollment
and prolong the duration of the trial and significantly impact
associated costs as well as impact other trial related activities
including, amongst others, manufacturing and regulatory reviews.
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, 2020, 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.
Company
Contact:Jack Callicutt, Chief Financial Officer(678)
620-3186ir@galectintherapeutics.com
Media Contact:Gregory
FCALexi Burchmore, Account Supervisor(215)
301-1181lexib@gregoryfca.com
Galectin Therapeutics and
its associated logo is a registered trademark of Galectin
Therapeutics Inc. Belapectin is the USAN assigned name for Galectin
Therapeutics’ galectin-3 inhibitor GR-MD-02.
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