JERUSALEM, July 11, 2017 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has agreed to schedule an End-of-Phase II meeting with Oramed for its successfully completed Phase IIb trial of its oral insulin capsule ORMD-0801 in the treatment of type 2 diabetes. The Phase IIb trial met primary and secondary endpoints by indicating a statistically significant lowering of glucose relative to placebo.
The purpose of the End-of-Phase II meeting, which is expected to take place on August 31, 2017, is to review the Phase IIb results with the FDA and seek guidance from the regulatory agency on the clinical design and protocol of Oramed's upcoming pivotal Phase III trial, in preparation for filing a New Drug Application (NDA).
"Effective and safe oral insulin delivery can change and improve the way diabetes is treated today. We are very encouraged by the Phase IIb results and have been diligently developing our Phase III protocol. We look forward to a very productive meeting with the FDA," stated Oramed CEO Nadav Kidron.
About ORMD-0801 Capsule for Type 2 Diabetes
Intestinally-absorbed oral insulin mimics insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream. ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or eliminating late-stage complications. Orally administered insulin is also expected to enhance patient compliance.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's PODTM technology is based on over 30 years of research by scientists at Jerusalem's Hadassah 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 of ORMD-0801 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).
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Forward-looking statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss the expected timing for our meeting with the FDA and our expected Phase III trial and NDA, as well as when we discuss 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 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 Securities and Exchange Commission.
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