NEW YORK, June 8, 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 that it has enrolled
and randomized over 50% of the 675 patients planned for its Phase 3
ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the
treatment of type 2 diabetes (T2D).
ORA-D-013-1 is the larger of Oramed's two Phase 3 studies 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 study,
ORA-D-013-2, commenced enrollment in March for a planned 450
patients. Efficacy data for ORA-D-013-1 will become available after
all patients have completed the first 6-month treatment period.
"As we continue on pace with randomization in the world's first
Phase 3 oral insulin study conducted under an FDA approved
protocol, we anticipate announcing topline results in 2022," said
Oramed CEO Nadav Kidron.
About the Study
ORA-D-013-1 is recruiting 675 patients who are currently on 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. Efficacy data
will become available after all patients have completed the first
6-month treatment period.
The ORA-D-013-1 trial is a double blind, double dummy study
randomizing patients 1:1:1 for: 8 mg ORMD-0801 once-daily at night
and placebo 45 minutes before breakfast; or 8 mg ORMD-0801
twice-daily at night and 45 minutes before breakfast; or placebo
twice daily at night and 45 minutes before breakfast.
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
randomization and expected timing of topline results of our Phase 3
studies, 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.