Press release

Oramed Initiates Phase 2 NASH Trial of Oral Insulin

NEW YORK, Dec. 2, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company

articleOramed Pharmaceuticals Inc.December 2, 20203/company/oramed-pharmaceuticals-inc/news/oramed-initiates-phase-2-nash-trial-of-oral-insulin-2020-12-02
Oramed Initiates Phase 2 NASH Trial of Oral Insulin

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[{"type":"text","content":"NEW YORK, Dec. 2, 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, announced today it has screened the first patients in a global trial of its oral insulin capsule ORMD-0801 for the treatment of Nonalcoholic steatohepatitis (NASH). The patients were screened at a U.S. site participating in Oramed's trial, being conducted at U.S., EU and Israeli clinical sites.\nThe trial will be comprised of eight clinical sites: three in the EU, three in the U.S. and two in Israel. The trial will measure efficacy endpoints via MRI-PDFF for 12-weeks dosing. For more information on the trial see: https://clinicaltrials.gov/ct2/show/NCT04616014?term=oramed&draw=2&rank=4. \n\"Based on the strong results from our previous study, where ORMD-0801 showed a 30% relative reduction in liver fat, we are excited to be starting this important international NASH trial and we look forward to sharing the data as it becomes available,\" stated Oramed CEO Nadav Kidron.\nAbout Oramed Pharmaceuticals\nOramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in New York and Israel, Oramed has developed a novel Protein Oral Delivery (PODâ„¢) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. The Company has 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 (Glucagon-like peptide-1) analog capsule, ORMD-0901.\nFor more information, please visit www.oramed.com.\nForward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the future sites, data and patient enrollment for the NASH study, the potential efficacy and benefits of ORMD-801, the validation of preliminary findings in future trials, the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes or revolutionizing the treatment...

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