The article presents the results of a 12-week multicenter, randomized, placebo-controlled trial assessing the safety and efficacy of multiple active doses of Oramed’s lead drug candidate ORMD-0801 in patients with uncontrolled Type 2 Diabetes (T2DM) on chronic background therapy with Metformin or combination oral therapy. The trial met the primary endpoint of statistically significant reductions of HbA1c from baseline to Week 12. In addition, the treatment doses were safe, well tolerated and not associated with weight gain or hypoglycemia.
“This paper presents interesting and important results of Oramed’s Phase 2 dose ranging study of oral insulin. Based on the results of this study, a bedtime dose of 8 mg is being carried forward into the Phase 3 registration studies,” said
The article can be accessed on Oramed’s website under Scientific Articles and Abstracts.
For more information, 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 plans for Phase 3 registration studies, as well as 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