Galectin Therapeutics Provides Final Randomization Status of NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
March 02 2023 - 8:00AM
Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading
developer of therapeutics that target galectin-3, announced that in
late December 2022, it ended the enrollment of new patients into
NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in
patients with liver cirrhosis caused by non-alcoholic
steatohepatitis (NASH). The last patient was randomized into
NAVIGATE at the end of February 2023. In order to be randomized,
the screening process documented the presence of clinical signs of
portal hypertension and validated the absence of esophageal and/or
gastric varices by a central adjudication of video recording of
upper esophago-gastric endoscopies. NAVIGATE has randomized 357
patients, above its initial objective of approximately 315
patients.
NAVIGATE is the first study of its kind and is a global effort
that recruited patients in 14 countries and on five continents. The
main efficacy objective is the primary prevention of esophageal
varices. Patients enrolled in the study have cirrhosis caused by
NASH and, because of the advancing cirrhotic process, have already
developed portal hypertension but have not yet developed dilated
veins in the esophagus known as esophageal varices, a clinically
concerning 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.
Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin
Therapeutics, said: “We are very pleased to achieve our
randomization objective for this study, the first of its kind to
address liver cirrhosis with portal hypertension. The treatment
period of the phase 2b portion is 18 months; therefore, the topline
results of the interim analysis are expected in the fourth quarter
of 2024. This will be a very important milestone for patients
affected by this disease and for their families, and we hope to
demonstrate a positive risk benefit for belapectin.”
Mr. Joel Lewis, the Company’s President and Chief Executive
Officer said: “We are gratified to reach this important milestone.
The last randomization will allow us to focus on efficiently
executing our program and other stated goals for the rest of the
year. On behalf of the whole team at Galectin Therapeutics, I again
want to personally thank our investigators and their teams, along
with all of the patients in the trial, for participating in this
innovative study. I also am extremely grateful for the commitment
and dedication of all of our employees in enabling us to reach this
milestone.”
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,” 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 affect 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.comGalectin
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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