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news.Enzo Biochem has received regulatory approval from Israel's Hebrew University-Hadassah Medical Center to initiate a phase II clinical trial of EGS21 for the treatment of non-alcoholic steatohepatitis, or fatty liver disease.
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Non-alcoholic steatohepatitis (NASH) is one stage in a disease spectrum that ranges from simple fatty liver, or steatosis, to steatohepatitis, advanced fibrosis, and end-stage cirrhosis. There is no effective medical therapy currently available for patients with non-alcoholic fatty liver disease.
This clinical trial 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 trial that showed positive trends towards a possible therapeutic effect of EGS21.
The phase II study is being partially funded by a $1 million grant from the Israel-US bi-national industrial R&D foundation (BIRD) and is expected to be initiated shortly.
The causes of NASH are not well defined, but the disease usually occurs together with obesity, type 2 diabetes and hyperlipidemia. The disease is estimated to affect 19% of the obese population and almost half of morbidly obese individuals.