JERUSALEM, April 5, 2016 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ:
ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical
company focused on the development of oral drug delivery systems,
announced today that all follow-up visits in the Company's Phase
IIb study of its oral insulin capsule, ORMD-0801, have been
completed.
The double-blind, randomized Phase IIb study of 180 patients
with type 2 diabetes was initiated on June
30, 2015 and conducted at 33 clinical sites in the United States. The study was designed to
generate ample data for both safety and efficacy endpoints.
Top-line results are expected later this quarter.
"We are pleased with the successful and timely completion of
this comprehensive study," stated Oramed CEO Nadav Kidron. "We look forward to
reporting top-line results shortly."
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 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 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). On December 29, 2015, Oramed announced the closing
of a $50 million + 10% royalties
licensing and investment agreement with Hefei Tianhui Incubation of
Technologies Co. Ltd. for its oral insulin capsule in China.
For more information, the content of which is not part of
this press release, please visit
http://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 clinical trials 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
Ariella Vaystooch
Office: +972-2-566-0001 ext.2
US: 1-718-831-2512 ext.2
Email: ariella@oramed.com
SOURCE Oramed Pharmaceuticals Inc.