Oramed's ORMD-0901 (Oral GLP-1 Analog) Found Safe and Well Tolerated in Phase Ib Study

Preparing to submit IND and commence U.S. FDA Phase IIb trial in 2017

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Nov 29, 2016, 08:30 ET

JERUSALEM, Nov. 29, 2016 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (www.oramed.com), a developer of oral drug delivery systems, today announced it successfully concluded a Phase Ib study of ORMD-0901, the Company's proprietary oral GLP-1 analog. The Phase Ib study on type 2 diabetic patients showed ORMD-0901 to be safe and well tolerated, having no serious adverse events, adverse events or abnormal laboratory findings during the study. In addition, the active oral GLP-1 arms of the study showed encouraging trending efficacy.

"We are very pleased with both the safety and efficacy results observed during this study. Currently we are preparing to submit an IND with the FDA and anticipate initiating a Phase IIb study in 2017," said Oramed CEO Nadav Kidron.

About ORMD-0901 – Oral GLP-1

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently marketed in injectable form only, and is indicated for treatment of type 2 diabetes. Exenatide induces insulin release at increased glucose levels and causes a feeling of satiety, which results in reduced food intake and weight loss. Oramed's oral GLP-1 analog capsule based on the company's POD^TM technology could significantly increase compliance and become a valuable tool in the treatment of diabetes.

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 Protein Oral Delivery (POD^TM) 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).

For more information, the content of which is not part of this press release, please visit www.oramed.com

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 preparation for and timing of our Phase IIb study, or when we discuss increasing compliance and 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.

Company Contact:
Oramed Pharmaceuticals
Estee Yaari
Office: +972-2-566-0001
US: +1-718-831-2512
Email: [email protected]

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SOURCE Oramed Pharmaceuticals Inc.