Galectin Therapeutics is dedicated to developing novel therapies to
improve the lives of patients with chronic liver disease and cancer.
Galectin’s lead drug (GR-MD-02) is a carbohydrate drug that inhibits the
galectin-3 protein that is directly involved in multiple inflammatory,
fibrotic, and malignant diseases. The lead development program is in
non-alcoholic steatohepatitis (NASH) with cirrhosis, a more advanced
form of NASH-related fibrosis. This is one of the most common liver
diseases and is believed to be amongst the largest drug development
opportunities available today. As many as one in four people globally
suffer from fatty liver disease, also known as NASH (non-alcoholic
steatohepatitis), with a lifetime risk of approximately 20 million
liver-related deaths among fatty liver disease patients currently alive.
Currently, the only treatment for patients with NASH and cirrhosis is a
liver transplant. The potential market opportunity for drugs targeting
NASH and cirrhosis is projected by analysts to be $35 – $40B worldwide
by 2025. Additional exploratory development programs are in combination
immunotherapy for advanced melanoma and other malignancies. Galectin
seeks to leverage extensive scientific and development expertise, as
well as established relationships with external sources, to achieve
cost-effective and efficient development.
GR-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-3 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 as well as experimentally induced pulmonary, renal, vascular
and cardiac fibrosis.
The target population of the Phase 3 clinical program will be patients
with NASH cirrhosis without esophageal varices. The basis for advancing
the drug product to Phase 3 is positive effects of GR-MD-02 on hepatic
venous pressure gradient (HVPG) and possible prevention or postponement
of development of esophageal varices observed in the Phase 2 NASH-CX
trial, which was reported on Dec. 5, 2017. The Company believes the
NASH-CX trial is the first large, randomized clinical trial of any drug
to demonstrate a clinically meaningful improvement in these patients.
The primary endpoint will be chosen from two endpoints that the FDA
agreed may be acceptable: A change in HVPG, which is a measure of liver
blood pressure, or progression to esophageal varices. Both primary
endpoints may be considered surrogate endpoints for clinical outcomes in
the target population with NASH cirrhosis. The potential choice between
two primary endpoints for Phase 3 trials provides enhanced flexibility
in designing the strongest trial to replicate the efficacy demonstrated
in the Phase 2 NASH-CX trial. Additionally, the clinical trial design
discussed with the FDA provides for interim analysis which may provide
confirmation of Phase 2 results and enhanced confidence for the ultimate
results of the Phase 3 trial. Please review important additional
information available at www.galectintherapeutics.com.
Galectin Therapeutics Inc.
Type of Organization:
CEO: Dr. Harold Shlevin
CFO: Jack W. Callicutt
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