Galectin Therapeutics Issued U.S. Patent For GR-MD-02 In Diabetic Nephropathy

(RTTNews) - Galectin Therapeutics Inc. (GALT) said that the U.S. Patent and Trademark Office has issued a patent for the Company's application titled "Galactose-Pronged Carbohydrate Compounds for the Treatment of Diabetic Nephropathy and Associated Disorders." The patent, assigned U.S. Patent No. 8,828,971, was issued September 9, 2014.

The patent covers both composition claim for and uses of the Company's carbohydrate-based galectin inhibitor compound GR-MD-02 in patients with diabetic nephropathy, a type of progressive kidney disease that occurs in individuals with diabetes.

Diabetic nephropathy is the major cause for chronic renal failure in the United States. The patent also covers other glomerulopathies, a set of diseases affecting function of the kidneys, that lead to renal failure. Pre-clinical studies have found that treatment of diabetic mice with GR-MD-02 reversed diabetic nephropathy.

GR-MD-02 is a complex carbohydrate molecule derived from apple pectin material that binds to galectin-3 protein thereby inhibiting its activity.

Galectin Therapeutics noted that it 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 primary endpoints for the Phase 1 trial - safety and pharmacokinetics - have been successfully met for the two cohorts completed. The dose of 4 mg/kg was safe and well tolerated and drug levels showed that the drug acted predictably and with a linear increase from the 2 mg/kg dose. A third cohort, which is currently in progress, will further add to the Company's pharmacokinetic knowledge and guide appropriate dose selection for Phase 2.