NEW YORK, Nov, 24, 2020
/PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq/TASE:
ORMP) (www.oramed.com), a clinical-stage pharmaceutical company
focused on the development of oral drug delivery systems, announced
today it has screened the first patients in its global Phase
3 trials of its oral insulin capsule ORMD-0801 for the treatment of
type 2 diabetes (T2D). The patients were screened at U.S.
sites participating in Oramed's ORA-D-013-1 trial, one of two Phase
3 trials being conducted in accordance with U.S. Food and Drug
Administration approved protocols.
Both Phase 3 trials, ORA-D-013-1 and ORA-D-013-2, will treat T2D
patients who have inadequate glycemic control over a period of 6 to
12 months. The double-blinded, placebo-controlled, multi-center
randomized trials will recruit a total of 1,125 patients to
evaluate the efficacy and safety of ORMD-0801. Efficacy data
will become available after all patients have completed the first
6-month treatment period.
"ORMD-0801 is the first oral insulin capsule to achieve the
requisite efficacy and safety data enabling us to run the world's
first FDA Phase 3 oral insulin trial. Oramed is proud to lead the
field in reaching this very significant diabetes treatment
milestone," stated Oramed CEO Nadav
Kidron.
About the Study
ORA-D-013-1 is recruiting 675 patients who are currently on 1, 2
or 3 oral glucose-lowering agents through 75 clinical sites
throughout the U.S. The primary endpoint of the study is to compare
the efficacy of ORMD-0801 to placebo in improving glycemic control
as assessed by A1c, with a secondary endpoint of assessing the
change from baseline in fasting plasma glucose at 26 weeks.
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 (POD™) technology. Oramed is seeking to transform 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
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.
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 efficacy,
safety and toleration of ORMD-801, the validation of preliminary
findings in future trials, the potential of ORMD-0801 to be the
first commercial oral insulin capsule for the treatment of diabetes
or revolutionizing the treatment of diabetes with our products. In
addition, historic results of scientific research and clinical
trials do not guarantee that the conclusions of future research or
trials will suggest identical or even similar conclusions. 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
+1-844-9-ORAMED
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.