Oramed Announces Last Patient Treated in Pivotal Phase IIb Trial of Oral Insulin ORMD-0801
NEW YORK, Sept. 17, 2019 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced the treatment of the last patient in the primary cohort of the Phase IIb HbA1c trial evaluating Oramed's lead oral insulin candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of Type 2 diabetes.
The Phase IIb double-blind, randomized, 90-day dose-ranging trial will assess the primary efficacy endpoint of reduction in HbA1c, as well as safety endpoints. Topline data from the primary cohort of the Phase IIb trial are expected to be released in the fourth quarter of 2019.
Oramed Chief Executive Officer Nadav Kidron said, "Our lead oral insulin program could be a major advancement for the diabetes community as we believe it should offer a healthier way to treat diabetes. With the last patient out in this pivotal trial, we have positioned ourselves as the leader in the clinical development of oral insulin."
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, with offices in New York and Israel, Oramed has developed a novel Protein Oral Delivery (PODTM) technology that is based on more than 30 years of research by scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of Type 2 and Type 1 diabetes. The Company has 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 (Glucagon-like peptide-1) analog capsule, ORMD-0901, which has potential to be the first orally-ingestible GLP-1 analog.
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 potential for ORMD-801 to be the first commercial oral insulin capsule for the treatment of Type 2 diabetes, the expected timing of release of topline data for the Phase IIb trial, the possibility that Oramed's oral insulin program would be a major advancement or healthier way to treat diabetes or revolutionizing the treatment of diabetes with Oramed's 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.
SOURCE Oramed Pharmaceuticals Inc.
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