NEW YORK, March 23, 2021 /PRNewswire/ -- 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 it has screened the first
patients in its ORA-D-013-2 study, the second of two concurrent
Phase 3 studies of its oral insulin capsule, ORMD-0801, for the
treatment of type 2 diabetes (T2D).
The studies are taking place under U.S. Food and Drug
Administration (FDA) approved protocols to treat T2D patients who
have inadequate glycemic control over a period of 6 to 12 months.
[Enrollment for the other Phase 3 study, ORA-D-013-1, is ongoing
and has surpassed 25%]. The double-blinded,
placebo-controlled, multi-center randomized studies will recruit a
total of 1,125 patients to evaluate the efficacy and safety of
ORMD-0801. Efficacy data for the studies will become available
after all patients have completed the first 6-month treatment
period.
"With both concurrent Phase 3 studies now enrolling, we have
achieved another world-first milestone, as the only company to
conduct two Phase 3 oral insulin studies under an FDA protocol.
While ORA-D-013-1 will help us evaluate our oral insulin capsule in
patients who are already on two or three glucose-lowering
medications, ORA-D-013-2 will help us assess our oral insulin
capsule in patients who are on diet control alone or on diet and
metformin monotherapy. Evaluating ORMD-0801 in these diverse
population groups is expected to yield compelling results for use
cases upon potential approval," stated Oramed CEO Nadav Kidron.
About the Study
The ORA-D-013-2 study is recruiting
450 T2D patients with inadequate glycemic control who are managing
their condition with either diet alone or with diet and metformin
monotherapy. Patients will be recruited through 28 sites in the
U.S. and 25 sites in Western
Europe and Israel. The
double-blind study will randomize patients 1:1 into two cohorts
dosed with 8 mg of ORMD-0801 at night and placebo at night. The
primary endpoint of the study is to compare the efficacy of
ORMD-0801 to placebo in improving glycemic control as assessed by
A1c over a 26-week treatment period, with a secondary endpoint of
comparing ORMD-0801 to placebo in maintaining glycemic control over
a 52-week treatment period.
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 the United
States 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 2 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 enrollment for our
studies, the potential efficacy, safety and toleration of ORMD-801,
the validation of preliminary findings in future trials and the
timing of results thereof, 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.