Oramed Pharmaceuticals has enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis (NASH).
The three-month treatment study, recently approved by Israel's Ministry of Health, will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH.
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Data from preclinical studies and clinical studies of ORMD-0801 demonstrate Oramed's oral insulin capsule has the potential to reduce inflammation of the liver.
"Prevalence of NASH is accelerating rapidly and correlates directly with the rising incidence of type 2 diabetes. As we continue our focus on the development of our oral insulin for the treatment of diabetes, we are excited about its potential in this greatly needed NASH indication," stated Oramed CEO, Nadav Kidron.
NASH, a chronic liver disease caused by excessive fat in the liver, can lead to fibrosis, cirrhosis, liver failure and death. According to the Journal of Hepatology, prevalent NASH cases are expected to increase 63% from 16 million in 2015 to 27 million cases in 2030.