Oramed Receives Israel Regulatory Approval to Conduct Human Study for New Oral Leptin Capsule

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JERUSALEM, May 2, 2017 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that based on positive preclinical data, the Company is developing a new drug candidate, a weight loss treatment in the form of an oral leptin capsule. Leptin, also known as the "obesity hormone" is a protein that regulates hunger. According to Grand View Research, the overall obesity market is expected to reach $15.6 billion in 2024.

Israel's Ministry of Health has approved Oramed's commencement of a proof of concept single dose study for its oral leptin drug candidate to evaluate its pharmacokinetic and pharmacodynamics (glucagon reduction) in ten type 1 diabetic patients.

"Obesity rates are increasing worldwide and contributing to many other health conditions including diabetes. Leptin's role in obesity is well defined and we believe an oral leptin capsule would have a role in helping to control and reduce obesity. An oral leptin capsule is an appropriate fit in our portfolio of drug candidates. Obesity and diabetes are highly correlated and insulin resistance has been found to generate leptin resistance," stated Oramed CEO, Nadav Kidron. "We look forward to initiating oral leptin studies in humans later this year."

About Leptin

Leptin, sometimes called the obesity, fat or satiety hormone, is a protein that is produced in fat cells located in adipose tissues and sends signals to the hypothalamus in the brain. Leptin helps to regulate and alter long-term food intake and energy expenditure. Leptin helps to inhibit hunger and regulate energy balance. Although leptin reduces appetite, obese individuals generally exhibit a higher concentration of leptin in their blood than normal weight individuals. These people show resistance to leptin, similar to resistance of insulin in type 2 diabetes.  Leptin has additionally been shown to suppress glucagon secretion and improve glucose levels in type 1 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 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).

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 our belief that an oral leptin capsule would have a role in helping to control and reduce obesity, when we discuss initiating oral leptin studies in humans later this year and 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.

Company Contact
Oramed Pharmaceuticals
Estee Yaari
+1-877-9-ORAMED
Email: [email protected]

SOURCE Oramed Pharmaceuticals Inc.