Epigen Biosciences, Inc. — Department of Health and Human Services SBIR Phase I: 300

Description

Summary The ultimate goal of this application is to develop one of Epigen’s proprietary, selective and drug-like kinase inhibitors for the effective treatment of liver fibrosis associated with chronic diseases such as non-alcoholic steatohepatitis (NASH), a severe type of non-alcoholic fatty liver disease (NAFLD). NAFLD is the most common liver disease and is associated with obesity and type-2 diabetes. There are no effective treatments available for NASH. Our approach will involve the pre-clinical evaluation of one advanced lead compound, identified according to a disease-specific progressive cutoff criteria, in two animal models of NASH to establish the proof-of-concept in this indication. The successful outcome of this work will enable initiation of efforts to establish a more detailed understanding of the pharmacology of the most promising candidate in rodent NASH models and commencement of toxicology and chemistry, manufacturing and controls (CMC) work to support filing of an investigational new drug (IND) application and eventually initiation of clinical trials in humans.Narrative The objective is to develop new drugs for treating diseases that lead to liver fibrosis, including non- alcoholic steato hepatitis (NASH), a significant cause of mortality.