The double-blind, multi-center trial is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline will be measured via MRI-PDFF following 12 weeks of dosing.
“With more than half of NASH patients having diabetes, ORMD-0801 has the potential to improve outcomes for patients in both conditions. NASH is a disease with a significant unmet medical need, as no drugs are currently approved to treat this condition, which is a leading cause of liver transplants in the
The global market for drugs to treat NASH is expected to reach
Non-alcoholic steatohepatitis (NASH) is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few management options.
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Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the safety and potential efficacy of ORMD-0801, the potential of ORMD-0801 to improve outcomes for patients in both NASH and diabetes or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. 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 finally 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