Enzo Biochem's EGS21 to enter Ph II trial

US gene-based health care firm Enzo Biochem has received regulatory approval from the Helsinki Committee of the Hebrew University-Hadassah Medical Center in Jerusalem, Israel, to initiate a Phase II randomized, double-blind clinical trial of EGS21 for the treatment of non-alcoholic steatohepatitis or fatty liver disease.

This clinical evaluation is based on successful preclinical studies carried out by Enzo scientists and collaborators followed by a Phase I safety trial of the drug and a pilot open-label clinical study that showed positive trends towards a possible therapeutic effect. This study is being partially funded by a $1.0 million grant from the Israel-US Binational Industrial R&D Foundation and is expected to be initiated shortly.

Non-alcoholic fatty liver disease is one of the most common causes of liver pathology in the USA. The condition is one stage in a disease spectrum that ranges from fatty liver or steatosis to steatohepatitis, advanced fibrosis and end-stage cirrhosis. It is estimated that approximately 8.6 million obese adult Americans may have NASH and another 30.1 million may have the milder form of fatty liver.