Galectin Therapeutics secures US patent for galectin inhibitor in 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, providing patent protection through 2031.

Fatty liver disease, which results in severe scarring of the liver (cirrhosis), affects as many as 15 million Americans. There are no currently approved pharmaceutical therapies. Intervention in fatty liver disease patients with advanced fibrosis, with the intent of reversing the fibrosis, is a potentially important therapeutic approach in this unmet medical need.

Galectin Therapeutics CEO, president and chief medical officer Dr Peter G Traber noted this patent, which provides patent protection through 2031, represents a major milestone for the company in that it covers the use of GR-MD-02 in our primary development program to treat patients with fatty liver disease with advanced fibrosis.

"Patent claims also cover the use of GR-MD-02 in combination with multiple other agents that may have potential activity in the disease that are under investigation elsewhere, including bile acids as in development by Intercept Pharmaceuticals," Traber added.

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. Applications are pending in multiple countries to extend patent protection globally.

Galectin Therapeutics is currently conducting a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics 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.

Last month, the company announced that patient enrollment in the first cohort of the Phase I trial was complete and results are expected to be announced around the end of the first quarter of 2014.