NEW YORK, Aug. 24, 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 platforms,
announced today that it has enrolled and randomized over 25% of the
planned 450 patients for its Phase 3 ORA-D-013-2 trial of its oral
insulin capsule ORMD-0801 for the treatment of type 2 diabetes
(T2D).
ORA-D-013-2 is the second of Oramed's two Phase 3 trials being
conducted 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. The concurrent trial,
ORA-D-013-1, completed enrollment and randomization of nearly 65%
of its 675 planned patients and is on track to complete
randomization with topline results expected in 2022.
"We are pleased with the pace of patient enrollment in the
world's first Phase 3 oral insulin trials conducted under a U.S.
FDA protocol, and look forward to providing further updates," said
Oramed Chief Executive Officer, 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
are being 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 (Nasdaq/TASE: ORMP) 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 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 pace of enrollment
and randomization and expected timing of topline results of our
Phase 3 studies or the potential of ORMD-0801 to be the first
commercial oral insulin capsule for the treatment of diabetes. 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.
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Company Contact:
Josh Hexter
+1-844-9-ORAMED
josh@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.