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Galectin Therapeutics Announces That Oral Treatment With Galectin-3 Inhibitor GR-MD-02 Is Efficacious In Preclinical Model Of Fatty Liver Disease With Fibrosis

NORCROSS, Ga., June 23, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that a preclinical study in a mouse model of NASH (non-alcoholic steatohepatitis, or fatty liver disease) demonstrated that oral administration of the Company's lead galectin-3 inhibitor, GR-MD-02, resulted in significant disease improvement.

Diabetic mice, fed a high fat diet to induce NASH, were treated after the development of disease with either a vehicle control (n=8) or GR-MD-02 (n=9) administered orally five days out of seven for a total of four weeks. The liver weight, liver-to-body weight ratio, and plasma triglyceride levels were significantly reduced in the GR-MD-02 treated animals as compared to vehicle control animals (p<0.05). Blood indicators of liver damage, including plasma AST (aspartate aminotransferase), plasma ALT (alanine aminotransferase), and plasma total bilirubin (TB) also demonstrated a statistically significant reduction following oral treatment with GR-MD-02 and, in fact, levels were reduced back to near normal levels (see accompanying figure here ). AST, ALT, and TB in normal animals (140 ± 86 U/L, 33 ± 8 U/L, 0.4 ± 0.0 mg/dL) were increased in the NASH animals treated with vehicle (293 ± 59 U/L, 87 ± 16 U/L, 0.56 ± 0.1 mg/dL) and were significantly reduced with oral GR-MD-02 treatment (159 ± 27 U/L, p<0.01; 46 ± 12 U/L, p<0.01; 0.4 ± 0.1 mg/dL, p<0.001). Each of these blood biomarkers indicate liver injury that improved with treatment.

Finally, fibrosis of the liver was significantly reduced with treatment with GR-MD-02, as indicated by the liver hydroxyproline content, a biochemical marker of collagen in the liver. Liver hydroxyproline content in the normal liver (0.48 ± 0.07 µg/mg total protein) was increased in the NASH animals treated with vehicle (0.76 ± 0.14 µg/mg total protein) and was significantly reduced with oral GR-MD-02 treatment (0.56 ± 0.12 µg/mg total protein, p<0.01).

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