NEW YORK, May 21, 2019 /PRNewswire/ --
- ORMD-0801 reaches significant milestone on path to potentially
be the first commercial oral insulin capsule for the treatment of
Type 2 diabetes
- Close to 300 patients have now been enrolled. 70% of
patients have already completed treatment in the study
- Top-line data expected in fourth quarter 2019
- Oral insulin delivery offers advantageous treatment for Type 2
diabetes by interacting with the body in a more physiological
way
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 it has completed enrollment for its 90-day dose-ranging Phase
IIb clinical study of its oral insulin capsule main cohort. Close
to 300 patients have now been enrolled. 70% (over 200) of
these patients have completed treatment in the study.
The Phase IIb double-blind, randomized study for Type 2 diabetes
was designed to identify the optimal dose to take into Phase
III studies. A primary efficacy endpoint of reduction in HbA1c
as well as safety endpoints are being assessed. A previous
28-day treatment study of 180 patients revealed a statistically
significant improvement from baseline in HbA1c levels. Longer term
treatment with ORMD-0801 has the potential for a more significant
positive impact on HbA1c, a key clinical measure of blood
sugar.
"Having completed recruitment of close to 300 patients, we are
on track to announce top line data in the fourth quarter this year.
We expect to begin our Phase III clinical trial design immediately
following the results," stated Oramed CEO, Nadav Kidron.
371 million people with Type 2 diabetes worldwide are in need of
treatment, representing an estimated $39
billion market in 2019.
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 (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 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, including
patient enrollment, recruitment for an extension 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 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: +1-877-9-ORAMED
Email: estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.