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.
Company Contact
Estee Yaari
Office: +972-2-566-0001 ext. 2
US: 1 844 9 ORAMED ext. 2
Email: estee@oramed.com
View original
content:http://www.prnewswire.com/news-releases/oramed-announces-last-patient-treated-in-pivotal-phase-iib-trial-of-oral-insulin-ormd-0801-300919465.html
SOURCE Oramed Pharmaceuticals Inc.