JERUSALEM, October 22, 2014 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
(http://www.oramed.com ), a clinical-stage pharmaceutical company
focused on the development of oral drug delivery systems, today
reported positive top-line clinical results from its Phase IIa
clinical trial of ORMD-0801, the company's proprietary oral insulin
capsules, to treat type 1 diabetes. The trial was conducted in
the United States under a U.S.
Food and Drug Administration (FDA) Investigational New Drug (IND)
protocol.
The prospective, randomized, double-blind, placebo controlled
study evaluated the safety and impact of ORMD-0801 given before
meals on the exogenous insulin requirements in 25 established type
1 diabetic patients. The primary endpoint of the study was the
change from baseline in exogenous insulin requirements (basal,
bolus and total) in patients treated with ORMD-0801, compared to
the change from baseline for patients treated with placebo. The
secondary endpoint of the study was the change from baseline in
mean nighttime, daytime and fasting glucose levels (by continuous
glucose monitoring) in patients treated with ORMD-0801, compared to
the change from baseline for patients treated with placebo.
The results showed that ORMD-0801 oral insulin given before
meals appeared to be safe and well-tolerated for the dosing regimen
in this study. Although the study was not powered to show
statistical significance, there were internally consistent trends
observed. Consistent with the timing of administration, the data
showed a decrease in rapid acting insulin, a decrease in
post-prandial glucose, a decrease in daytime glucose by continual
glucose monitoring and an increase in post-prandial hypoglycemia in
the active group.
"We are very pleased with the outcome of this study and look
forward to sharing it with the scientific community," commented
Miriam Kidron, Ph.D., Chief
Scientific Officer of Oramed. "We continue to build our body of
human clinical data in support of the use of ORMD-0801 to treat
both type 1 and type 2 diabetes. With the data gathered so
far, we look forward to initiating our Phase IIb study of ORMD-0801
in type 2 diabetes patients later this year."
The company intends to hold a conference call on November 3rd, 2014 at 10:00 a.m. Eastern Time to present detailed data
from the study. More details to follow.
About Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which the pancreatic
beta cells responsible for insulin secretion are attacked by the
immune system. In the absence of self-produced insulin and the
concomitant glycemic control, there is a need to supply extraneous
insulin in order to regain glycemic control and prevent future
disease complications that include heart disease, blood vessels
disease, nerve and eye disease, infections, hypoglycemic events and
many more ailments. According to the International Diabetes
Federation, type 1 diabetes is on the rise at a rate of 3% per year
and currently affects approximately 36 million people worldwide -
about 10% of the global diabetes population. The disease was
formerly known as juvenile diabetes, and currently affects both
pediatric and adult populations.
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™) 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). Having completed separate
Phase IIa clinical trials in patients with both type 1 and type 2
diabetes, the company anticipates the initiation of separate Phase
IIb clinical trials under an Investigational New Drug application
with the U.S. Food and Drug Administration. In addition, the
company 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 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,
including the expected timing thereof, 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 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 Securities and Exchange
Commission.
Company Contact
Ariella Nachman
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: ariella@oramed.com
SOURCE Oramed Pharmaceuticals Inc.