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Oramed Receives Approval to Conduct Clinical Study for Treatment of NASH w/ Oral Insulin

Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that Israel’s Ministry of Health has granted the Company approval 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. Incidence of NASH is rapidly increasing, similar to the rates of increase in diabetes. We look forward to exploring ORMD-0801 as a potential treatment for NASH,” stated Oramed CEO, Nadav Kidron. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).

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