- ORMD-0801 positioned to potentially be the first FDA approved oral insulin for the treatment of diabetes
- Completed enrollment of 710 patients for the Phase 3 ORA-D-013-1 study
- Top line data expected in
January 2023
ORA-D-013-1 is the larger of Oramed’s two Phase 3 studies being conducted under
“We are thrilled to announce that the world’s first Phase 3 oral insulin study, conducted under an FDA protocol, has achieved a significant milestone with the completion of enrollment. Following the last patient’s six months of treatment, we anticipate announcing topline results in
About the Study
The ORA-D-013-1 study initially aimed to enroll 675 patients and has now completed its enrollment oversubscribed with a total of 710 patients. The enrolled patients are currently on 2 or 3 oral glucose-lowering agents through 96 clinical sites throughout the
About
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 expected timing of topline results of the Phase 3 study 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
Video – https://www.youtube.com/watch?v=t_emiPyO6Ik
Logo – https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg
Company contacts:
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com
egoldstein@lifesciadvisors.com
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