Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on January 30, 2013. The IND application supports a proposed indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis, or fatty liver disease.
“This IND submission is the first step in the clinical development program of GR-MD-02 for the treatment of liver fibrosis,” said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. “We are leveraging our leadership in galectin science to bring new treatment options for these severely underserved patients and strongly believe that our novel approach of inhibiting galectin may be the key to the prevention and reversal of liver fibrosis.”
The IND application includes twenty seven (27) individual studies that characterize the pharmacology, pharmacokinetics, and toxicology of GR-MD-02 in a number of animal species, including the effects in various animal models of disease. Additionally, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. This information provides a description of how the drug works and why we believe it is likely to be safe in humans and provides a description of its possible mechanism of action in humans. The main purpose of the IND is to share with the FDA the extensive non-clinical data that we believe predicts for an acceptable safety profile when GR-MD-02 is first administered to humans in the initial early-stage clinical studies. The FDA will review this application and determine the acceptability of the data to predict the safety of GR-MD-02 before Galectin Therapeutics begins an initial human Phase 1 clinical trial. It is possible that the FDA will require additional information. If the FDA determines that the submitted package of data is acceptable, the Company plans on proceeding with a Phase 1 clinical trial. Future communications will outline study design and timing.