Oramed Pharmaceuticals (NASDAQ:ORMP) received approval from Israel's Ministry of Health to initiate an exploratory clinical study of its oral insulin capsule, ORMD-0801, in patients with nonalcoholic steatohepatitis (NASH).
The proposed three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. Oramed plans on initiating the study in the coming month.
"Data from our directed preclinical NASH studies and clinical studies of ORMD-0801 in diabetics has revealed, through exploratory endpoints, that our oral insulin capsule has the ability to reduce inflammation of the liver,” CEO, Nadav Kidron, said in a statement.
“Incidence of NASH is rapidly increasing, similar to the rates of increase in diabetes,” he added.