NORCROSS, Ga., Sept. 10, 2013 (GLOBE NEWSWIRE) — Galectin Therapeutics ( GALT ), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of issuance from the U.S. Patent and Trademark Office for Patent Application Number 13/573,454 titled “Galacto-rhamnogalacturonate compositions for the treatment of non-alcoholic steatohepatitis and non-alcoholic fatty liver disease.” The patent covers the Company’s carbohydrate-based galectin inhibitor compound GR-MD-02 for use in patients with fatty liver disease with or without fibrosis or cirrhosis. Fatty liver disease affects as many as 15 million Americans, results in severe scarring of the liver (cirrhosis), and there are no currently approved pharmaceutical therapies.
The U.S. Food and Drug Administration (FDA) recently granted GR-MD-02 Fast Track designation for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis. Galectin Therapeutics is currently conducting a Phase 1 clinical trial to evaluate the safety, tolerability and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 over four weekly doses of GR-MD-02 treatment in patients with fatty liver disease with advanced fibrosis.
“The issuance of this patent provides broad coverage in the U.S. for the use of GR-MD-02 in fatty liver disease through September 2031 and international patent coverage is pending for the same intellectual property,” said Peter G. Traber, MD, President, CEO and CMO of Galectin Therapeutics. “There is a truly vast unmet medical need for the treatment of fatty liver disease with fibrosis, as the most prevalent liver disease in the U.S. We are hopeful that our development program for GR-MD-02 will lead to the first therapy for this unmet medical need.”
The patent inventors include Peter Traber, Eliezer Zomer and Anatole Klyosov with assignment to Galectin Therapeutics. The major claims are for methods of obtaining galectin inhibitor compounds, obtaining a composition for parenteral or enteral administration in an acceptable pharmaceutical carrier and administering to a subject having at least one of the following: fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, non-alcoholic hepatitis with liver fibrosis, non-alcoholic steatohepatitis with cirrhosis, or non-alcoholic steatohepatitis with cirrhosis and hepatocellular carcinoma. The use covers reversing or slowing the progression of disease activity or medical consequences of the disease. Moreover, additional claims cover the use of the galectin inhibitor compounds in combination with multiple other agents that may have potential activity in the disease that are under investigation elsewhere.
About Fatty Liver Disease with Advanced Fibrosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual