NEW
YORK, Nov. 29, 2022 /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, today announced that Diabetes,
Obesity, and Metabolism, has published an original
article titled: "Oral Insulin (ORMD-0801) in Type 2 Diabetes
Mellitus: Dose-Finding 12-Week Randomized Placebo-Controlled
Study," authored by Roy Eldor,
MD PhD, Bruce H. Francis, MD,
Alexander Fleming, MD, Joel Neutel, MD, Kenneth
Homer, MS, Miriam Kidron,
PhD, and Julio Rosenstock, MD.
The article presents the results of a 12-week multicenter,
randomized, placebo-controlled trial assessing the safety and
efficacy of multiple active doses of Oramed's lead drug candidate
ORMD-0801 in patients with uncontrolled Type 2 Diabetes (T2DM) on
chronic background therapy with Metformin or combination oral
therapy. The trial met the primary endpoint of statistically
significant reductions of HbA1c from baseline to Week 12. In
addition, the treatment doses were safe, well tolerated and not
associated with weight gain or hypoglycemia.
"This paper presents interesting and important results of
Oramed's Phase 2 dose ranging study of oral insulin. Based on the
results of this study, a bedtime dose of 8 mg is being carried
forward into the Phase 3 registration studies," said Roy Eldor, MD PhD, Director, Diabetes Unit,
Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv
Sourasky Medical Center, and a member of Oramed's Scientific
Advisory Board.
The article can be accessed on Oramed's website under Scientific
Articles and Abstracts.
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 plans for Phase 3
registration studies, as well as 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:
Zach
Herschfus
+1-844-9-ORAMED
zach@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.