NEW YORK, March 16, 2021 /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 that it has enrolled
and randomized 25% 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 one of two concurrent Phase 3 studies 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 double-blinded, placebo-controlled,
multi-center randomized study will evaluate the efficacy and safety
of ORMD-0801. Efficacy data will become available after all
patients have completed the first 6-month treatment period.
"We are very pleased with the pace of patient enrollment in this
ORA-D-013-1 study, which keeps us on track to complete
randomization of all 675 patients by the end of 2021, as we look
ahead to topline results next year," 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 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 timing of the
completion of patient enrollment and topline results of the
ORA-D-01301 study, the potential efficacy and safety of ORMD-801,
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.