JERUSALEM, May 18, 2016 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ:
ORMP), today announced positive top-line results from its Phase IIb
study, designed to evaluate the safety and efficacy of its oral
insulin capsule (ORMD-0801) in patients with type 2 diabetes. The
study's primary objective, a significant reduction of weighted mean
night-time glucose, was successfully achieved.
"This demonstration of safe and effective oral insulin delivery
represents a transformative event in the treatment of type 2
diabetes," said Nadav Kidron, Oramed
CEO. "We are delighted with the results and look forward to moving
into Phase III trials."
This US based double blind, 28 day, randomized study of 180
adult type 2 diabetic patients showed a statistically significant
decrease in the primary endpoint, pooled night-time glucose mean
percentage change of 6.47% from run-in, between placebo and active
cohorts (p=0.0268). The study additionally demonstrated a good
safety profile with no drug related serious adverse events.
"These are very impressive results that confirm the efficacy of
orally delivered intestinally absorbed insulin," said Dr.
Michael Berelowitz, Head of Oramed's
Scientific Advisory Board. "The promise of this more physiological
delivery system for insulin is the inhibition of hepatic glucose
production, which was clearly demonstrated via the significant
reduction in night-time glucose levels in patients who received
ORMD-0801."
The Company plans to present and publish more comprehensive data
in the future.
Conference Call today, May 18, at
11:00 am Eastern Time
Oramed will host a conference call to discuss the study
results.
Interested parties may access the call at: +1-866-254-0808 (US)
or +44-145-254-1003 (UK). Conference ID: 8327230
About the Phase IIb Oral Insulin Study
The double-blind, randomized Phase IIb study of 180 patients
with type 2 diabetes was initiated on June
30, 2015 and was conducted at 33 clinical sites in
the United States under an IND
that was approved by the FDA. The study was designed to generate
data to assess the safety and efficacy of multiple oral bedtime
doses of ORMD-0801 in adult patients with type 2 diabetes mellitus
who are inadequately controlled with diet and metformin. The study
was comprised of three arms: placebo, ORMD-0801 16mg and ORMD-0801
24 mg. Patients were dosed before bed-time, and their
night-time glucose levels (6 hours post dose) were continuously
monitored.
For more information on the study, which does not form a part of
this press release, see:
https://clinicaltrials.gov/ct2/show/NCT02496000?term=oramed&rank=5
About ORMD-0801
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 even eliminating late-stage complications. Orally
administered insulin is expected to enhance patient compliance. In
addition, intestinally absorbed-oral insulin mimics insulin's
natural location and gradients in the body by first passing through
the liver before entering the bloodstream.
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
(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).
For more information, the content of which is not part of
this press release, please
visithttp://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 Phase IIb study,
that the demonstration of safe and effective oral insulin delivery
represents a transforming event in the treatment of type 2
diabetes, when we discuss moving into Phase III trials, when we
discuss ORMD-0801 and its potential to create a new paradigm in the
treatment of diabetes by oral delivery of insulin, or 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
Office: +972-2-566-0001
US: +1-718-831-2512
Email: estee@oramed.com
SOURCE Oramed Pharmaceuticals Inc.