Oramed Enrolls First Patient in Its Clinical Study for Oral Insulin in the Treatment of NASH

NEW YORK, Oct. 4, 2018 /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 enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis (NASH).

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The three-month treatment study, recently approved by Israel’sMinistry of Health, will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH.

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.

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’sHadassah 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).

For more information, the content of which is not part of this press release, please visit www.oramed.com.

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential of ORMD-0801 to reduce inflammation of the liver, the timing of expected clinical development programs and clinical trials or revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the U.S. Securities and Exchange Commission.

Company contact
Oramed PharmaceuticalsJosh Hexter+1-844-9 ORAMED ext. 2
Email:  josh@oramed.com

Cision View original content:http://www.prnewswire.com/news-releases/oramed-enrolls-first-patient-in-its-clinical-study-for-oral-insulin-in-the-treatment-of-nash-300724408.html

SOURCE Oramed Pharmaceuticals Inc.

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