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ORMP: Positive Takeaways of Preliminary NASH Study Findings

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By M. Marin



Oramed Pharmaceuticals Inc. (NASDAQ:ORMP), a clinical-stage pharmaceutical company with a proprietary oral protein delivery platform technology, presented preliminary data findings from its NASH study at the American Diabetes Association Scientific Session 2020 this week. The company announced that its NASH study has shown ORMD-0801 to be safe and well tolerated thus far, with an encouraging lowering of fatty liver content. NASH is currently estimated to affect 3%-12% of the U.S. adult population, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

ORMD-0801, an oral insulin, that is being tested in both type 1 (T1D) and type 2 diabetics (T2D), is the company’s lead development candidate. The company is also developing ORMD0901, an oral glucagon-like peptide-1 (GLP-1), and an oral leptin for the treatment of obesity in patients with T1D. The company believes that ORMD-0801 could become the first commercial oral insulin capsule for the treatment of diabetes.

NASH Trial Shows Early Positive Signs of Treatment Using ORMD-0801

In October 2018, Oramed began an exploratory clinical study to evaluate ORMD-0801, its oral insulin candidate, in patients with nonalcoholic steatohepatitis (NASH), testing the ability of ORMD-0801 to reduce liver fat, inflammation, and fibrosis in NASH patients.

NASH is inflammation and damage to the liver reflecting a buildup of fat. It is the most severe form of nonalcoholic fatty liver disease (NAFLD). Moreover, many, if not most, people with NASH are relatively asymptomatic and therefore do not even realize that they have a liver problem. However, NASH can be severe and put patients at higher risk to develop cirrhosis, liver failure and hepatocellular carcinoma.

According to the National Institutes of Health (NIH), NAFLD is currently estimated to affect up to one billion people globally. It is estimated to be the most common cause of chronic liver disease in the U.S., with 80 to 100 million people affected and some 25% of afflicted patients progressing to NASH. The number of NASH cases is also expected to increase by as much as 63% from 2015 to 2030, according to NIH, driven by rising obesity rates, unmet medical needs and sedentary lifestyles, among other factors. Estimates of the global NASH drug treatment market range from about $20 billion to higher by the mid-2020’s.

The study of the first eight patients in Oramed’s NASH trial showed that the 12-week, once-daily treatment of ORMD-0801 had no serious adverse events, and induced an observed mean 6.9±6.8% reduction in liver fat content. The relative reduction, as measured by MRI-PDFF, was 30%. The data suggests that ORMD-0801 can have a positive effect in people with type 2 diabetes.

The company announced that its NASH study has shown ORMD-0801 to be safe and well tolerated thus far, with an encouraging lowering of fatty liver content. Oramed is expanding the NASH study to 30 patients and intends to have additional sites in Israel, Europe and potentially the U.S., as well. The study is planned ultimately to enroll 40 patients.

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