Press release
Oramed Announces Positive Initial Clinical Trial Results for Treatment of NASH With Oral Insulin
Data Presented at the American Diabetes Association Scientific Session 2020 NEW YORK, June 15, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP)
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"Data Presented at the American Diabetes Association Scientific Session 2020\n\n\nNEW YORK, June 15, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced that its pilot study of its oral insulin candidate ORMD-0801 in type 2 diabetes patients with non-alcoholic steatohepatitis (NASH), has shown ORMD-0801 to be safe and well tolerated thus far, with an encouraging lowering of fatty liver content, as seen by MRI- derived proton density fat fraction (MRI-PDFF).\n\n \n \n \n \n \n \n\n \nThe data is being presented in a poster at the 80th American Diabetes Association (ADA) Scientific Sessions, held virtually this year, June 12-16, 2020.\nThe pilot, open-label study of the first 8 patients of a planned 40-patient multi-center study, aimed to assess the safety, tolerability, and early effects of 16 mg ORMD-0801 (2x8 mg capsules) on liver fat in type 2 diabetes patients with NASH. The 12-week, once-daily treatment had no serious adverse events, and induced an observed mean 6.9±6.8% reduction in liver fat content (sign test p value: 0.035), and the relative reduction was 30%, [see graph] as measured by MRI-PDFF. In parallel, concentrations of gamma-glutamyltransferase (GGT), a key marker of chronic hepatitis, were significantly lower after 12 weeks of treatment as compared to baseline (-14.6±13.1 U/L; sign test p value: 0.008), as were fasting insulin levels (-96.5±206.0 pmol/L; sign test p value: 0.035). \nOramed's CEO, Nadav Kidron, said, \"These preliminary observations suggest a positive effect of oral insulin on NASH in people with type 2 diabetes, as shown by reductions in liver fat content. We look forward to further validating these encouraging findings in the larger population of this study and in large-scale, randomized clinical trials.\" \nIn addition to the NASH data, Oramed is presenting two posters illustrating ORMD-0801's impact on type-2 diabetes mellitus (T2DM). Oramed's poster presentations at the ADA include:\nOral Insulin (ORMD-0801) Effects on Glucose Parameters in Uncontrolled T2DM on Oral Antibiotic Drugs (OADs), Presented by Dr. Julio Rosenstock, Director of the Dallas Diabetes Research Center and Scientific advisory board member at Oramed Pharmaceuticals Oral...