NEW YORK, March 19, 2020 /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 positive feedback
from its initial End-of-Phase 2 (EoP2) meeting with the U.S. Food
and Drug Administration (FDA) to discuss Chemistry Manufacturing
and Control (CMC) of its lead oral insulin capsule ORMD-0801.
The meeting, held in February, followed the successful
completion of Oramed's Phase 2b trial
of ORMD-0801 for the treatment of type 2 diabetes (See Press
Release dated November 12, 2019),
which achieved its primary endpoint, the reduction in HbA1c
compared to placebo at week 12.
During this meeting the FDA provided feedback on key issues
relating to Drug Product manufacture and supported continuing to
Phase 3 clinical development. The Company expects an additional
meeting with the FDA following deeper analysis of the data from the
Phase 2b trial, during which the
Company anticipates receiving the FDA's guidance on the Phase 3
study design.
Oramed's Chief Executive Officer, Nadav
Kidron, said, "We are very pleased with the productive and
constructive feedback from the FDA as we continue on the path to
bring oral insulin to market. We look forward to further
discussions with the FDA and to their guidance in regards to our
anticipated Phase 3 trial."
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 (PODâ„¢) technology that is based on more than 30 years
of research by scientists at Jerusalem's Hadassah Medical
Center. Oramed is seeking to revolutionize 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 type 2 and type 1
diabetes. The Company has completed multiple Phase 2 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 potential of
ORMD-0801 to be the first commercial oral insulin capsule for the
treatment of diabetes, revolutionizing the treatment of diabetes
with our products, the timing of expected clinical development
programs and clinical trials and discussions with and guidance from
the FDA. 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
Estee
Yaari +1-844-9-ORAMED
Email: estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.