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Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced its clinical development program for the treatment of non-alcoholic steatohepatitis (NASH), or fatty liver disease, with advanced fibrosis. Galectin Therapeutics has selected GR-MD-02, a novel galectin inhibitor discovered by the Company, as its lead candidate for NASH, which is expected to enter clinical trials in early 2013. NASH represents a major unmet medical need, affecting 9 to 15 million Americans, with the only treatment option being liver transplantation.
“Patients who undergo liver transplantation for advanced fibrosis carry a high possibility of disease recurrence because the underlying cause of the fibrosis is not addressed,” said Peter G. Traber, MD, President, CEO and CMO of Galectin Therapeutics. “GR-MD-02 has demonstrated the ability to not only prevent, but reverse liver fibrosis in preclinical mouse models of NASH, suggesting that this candidate could represent a disease-modifying treatment option. We are currently conducting the final preclinical studies and have trial design guidance from the Food and Drug Administration which will support an IND submission by the end of 2012.”
GR-MD-02 is a carbohydrate-based candidate that inhibits galectins, key modulators of liver fibrosis. In several preclinical studies, GR-MD-02 was able to prevent and reverse liver fibrosis in mouse models of NASH. In addition, GR-MD-02 was able to reverse the inflammatory component of NASH (fat accumulation, liver cell degeneration and inflammatory cell infiltration). The ability of GR-MD-02 to reduce existing fibrosis is further supported by studies in toxin-induced fibrosis. Toxicology, pharmacology and manufacturing studies are currently being conducted to support submission of an IND application to the FDA by the end of 2012. A Phase 1 clinical trial in patients with NASH with advanced fibrosis is anticipated to begin in the first quarter of 2013.
NASH is a common disease of the liver, affecting 9 to 15 million people in the United States and 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 NASH can develop fibrosis, or scarring of the liver, that can lead to cirrhosis, a severe liver disease where transplantation is the only current treatment available. Galectin Therapeutics is developing drug candidates as an alternative to transplantation and lead candidates have reversed fibrosis in preclinical disease models.