(By Balaseshan) Galectin Therapeutics Inc. (NASDAQ: GALT) said it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on January 30 for the treatment of fatty liver disease.
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. NASH has become a common disease of the liver with the rise in obesity rates, affecting 9 to 15 million people, including children, in the U.S.
The application includes 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.
[Related -Galectin Therapeutics (GALT): FDA OKs Advanced Fibrosis Human Trial]
Galectin said the main purpose of the IND is to share with the FDA the extensive non-clinical data that the company believes predict 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.
On January 22, Galectin announced new preclinical data on the efficacy of anti-galectin therapy on diabetic kidney disease. Treatment of diabetic mice with GR-MD-02 was found to reverse the primary kidney disease associated with diabetes, called diabetic nephropathy, the leading cause of kidney failure, dialysis and kidney transplant.
[Related -Galectin Therapeutics (GALT) Receives Liver Disease Treatment Patent; Shares Jump]
In the preclinical study, diabetic mice developed histological findings consistent with diabetic nephropathy, consisting of glomerular lesions in the form of diffuse mesangial matrix accumulation and proliferation. The kidneys of the diabetic mice also showed fibrosis evidenced by interstitial collagen deposition.
Treatment with GR-MD-02 reduced the mesangial matrix accumulation, which suggests the drug suppressed the production and/or accumulation of extracellular matrix components. Additionally, GR-MD-02 markedly reduced the area of interstitial fibrosis.
GALT is trading down 1.94% at $2.60 on Thursday. The stock has been trading between $1.60 and $6.00 for the past 52 weeks.