Oramed Receives FDA Clearance for IND Application for Its Oral GLP-1 Analog Capsule
NEW YORK, Sept. 17, 2018 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: 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 cleared its Investigational New Drug (IND) application for human trials of its oral GLP-1 analog capsule ORMD-0901.
Glucagon-like peptide (GLP-1) analogs, which mimic the natural GLP-1 hormone in the body, are used in the treatment of type 2 diabetes and currently only available via injection. In a prior Phase 1 study on type 2 diabetic patients, Oramed's ORMD-0901 capsule was well tolerated and showed encouraging efficacy, including reducing blood sugar levels following a standard meal as compared to a placebo.
Oramed's planned Phase 1 pharmacokinetic (PK) study is a fully-randomized, single-blind, placebo-controlled 4-way crossover study which will evaluate safety in addition to the pharmacokinetics of ORMD-0901 compared to placebo and to open label Byetta®, a GLP-1 analog currently on the market, in up to 15 healthy subjects.
"We are pleased to receive the FDA's clearance of our IND and we plan to initiate this small PK and dosing study in the current quarter. Upon its completion, we anticipate initiating a broader Phase 2 study of ORMD-0901 in the U.S. in 2019," stated Nadav Kidron, CEO of Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top 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 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. For example, we are using forward-looking statements when we discuss the timing of expected clinical development programs and clinical trials and FDA submissions or 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 final 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 U.S. Securities and Exchange Commission.
Company Contact
Oramed Pharmaceuticals
Josh Hexter
+1-844-9 ORAMED ext. 2
Email: [email protected]
SOURCE Oramed Pharmaceuticals Inc.
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