Galectin Therapeutics Reports the Positive Outcome of the Third Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
March 16 2023 - 8:00AM
Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading
developer of therapeutics that target galectin-3, today reported
the positive outcome of its third data and safety monitoring board
(DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3
study of belapectin in patients with liver cirrhosis caused by
non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study
of its kind and is a global effort that randomized 357 patients in
14 countries on five continents. The main efficacy objective is the
primary prevention of esophageal varices. Interim topline data from
the Phase 2b portion of NAVIGATE is expected in the fourth quarter
of 2024.
Patients enrolled in the study have liver cirrhosis caused by
NASH and, because of the advancing cirrhotic process, have already
developed portal hypertension but have not yet developed esophageal
varices as a complication of portal hypertension. Portal
hypertension is the consequence of the unrelented inflammatory and
fibrotic process occurring in the liver and dramatically increases
the risk of developing esophageal varices, a potentially
life-threatening complication of liver cirrhosis.
The objective of this third independent DSMB was to further
review the emerging tolerance and safety profiles of belapectin.
Based on its deliberation, which included an unblinded review of
the data collected thus far, the DSMB concluded that NAVIGATE can
continue as designed, without modifications.
Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin
Therapeutics, said: “The third positive recommendation of the DSMB
meeting is an additional important milestone for Galectin
Therapeutics and for patients affected by liver cirrhosis caused by
NASH. The study is now fully randomized, and we are continuing to
collect a large amount of safety data. This third recommendation
further strengthens our confidence that belapectin will offer a
beneficial risk-benefit profile. Because of the cirrhotic process
and the multiple co-morbidities of the metabolic syndrome, as well
as the high incidence of type 2 diabetes and obesity, NAVIGATE
patients are generally on several medications and at risk of
multiple complications, including infectious events triggered by an
immune deficient state. In this context, a candidate drug designed
for cirrhotic patients must be safe and well-tolerated. Currently,
patients with decompensated liver cirrhosis have no hope other than
to receive a liver transplantation. A liver transplantation is a
complex and expensive procedure, requiring life-long
immunosuppression and specialized follow-up, and is dramatically
rationed by a global shortage of organs. With the NASH epidemy and
the resulting increasing number of patients that will suffer from
liver cirrhosis, the liver organ shortage is only going to get
worse, further highlighting the urgent need for new treatments. I
again want to take this opportunity to thank patients and their
families, investigators and their teams for participating in this
innovative study.”
About BelapectinBelapectin 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, and these results provide the
basis for the conduct of the NAVIGATE trial. The NAVIGATE trial
(www.NAVIGATEnash.com), titled “A Seamless Adaptive Phase 2b/3,
Double-Blind, Randomized, Placebo-controlled Multicenter,
International Study Evaluating the Efficacy and Safety of
Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in
NASH Cirrhosis,” began enrolling patients in June 2020, and is
posted on www.clinicaltrials.gov (NCT04365868).
Galectin-3 has a significant role in cancer, and the Company has
supported a Phase 1b study in combined immunotherapy of belapectin
and KEYTRUDA in advanced melanoma and in head and neck cancer. This
trial provided a strong rationale for moving forward into a
Company-sponsored Phase 2 development program, which the company is
exploring.
About Fatty Liver Disease with Advanced Fibrosis and
CirrhosisNon-alcoholic steatohepatitis (NASH) has become a
common disease of the liver with the rise in obesity and other
metabolic diseases. NASH is estimated to affect up to 28 million
people in the U.S. It is characterized by the presence of excess
fat in the liver along with inflammation and hepatocyte damage
(ballooning) in people who consume little or no alcohol. Over time,
patients with NASH can develop excessive fibrosis, or scarring of
the liver, and ultimately liver cirrhosis. It is estimated that as
many as 1 to 2 million individuals in the U.S. will develop
cirrhosis as a result of NASH, for which liver transplantation is
the only curative treatment available. Approximately 9,000 liver
transplants are performed annually in the U.S. There are no drug
therapies approved for the treatment of liver fibrosis or
cirrhosis.
About Galectin TherapeuticsGalectin
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 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 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,
findings of safety of a drug candidate are not indicative of the
drug candidate’s efficacy; 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 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 coronavirus may
continue to impact NASH patient populations around the globe and
further slow trial enrollment and prolong the duration of the trial
and significantly impact associated costs. 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, 2021,
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
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
belapectin (GR-MD-02).
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