NEW YORK, Nov. 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 that it has enrolled
and randomized over 75% 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. Efficacy data for
ORA-D-013-1 will become available after all patients have completed
the first 6-month treatment period. The concurrent study,
ORA-D-013-2, commenced enrollment in March for a planned 450
patients.
"We are excited to announce that we are nearing the end of
enrollment in the world's first Phase 3 oral insulin study
conducted under the FDA protocols and 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 study 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: ORMP) (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 is being evaluated in two pivotal Phase
3 studies and has the potential to be the first commercial oral
insulin capsule for the treatment of diabetes. 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 and 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.
Company Contact
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.