NEW YORK, Nov. 19, 2019 /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, conducted an investor event and
conference call yesterday, November 18,
2019, where a panel of investigators and Key Opinion Leaders
presented detailed findings from the Company's successful Phase IIb
study of ORMD-0801 in the treatment of type 2 diabetes.
Panelists presenting the data included: Dr. Joel Neutel, Principal Investigator of the study
and Director of Research at Orange County Research Center;
Kenneth Homer, the trial's
biostatistician; Dr. Ramachandra Naik, Professor of
Medicine/Endocrinology at SUNY Upstate Medical
University; and Dr. Alexander
Fleming, CEO of Kinexum, and former Head of Clinical Review
of Endocrine and Metabolic Drugs at the U.S. Food and Drug
Administration (FDA).
Key highlights from the investor event included the
following:
Comments by Dr. Naik:
- ORMD-0801 has the potential to be used as a second, third, and
fourth line oral agent for the treatment of type 2 diabetes. The
Phase IIb data has shown efficacy in patients whose diabetes was
inadequately controlled either on metformin alone, or metformin
with up to two additional oral antihyperglycemic agents, with the
latter group constituting the majority.
- Being on multiple antihyperglycemic agents implies that
patients are in more advanced stage in the natural history of the
disease and it is noteworthy that ORMD-0801 had a statistically
significant and clinically meaningful benefit in those
patients.
- The glycemic efficacy along with reassuring safety profile,
support a unique mechanism of action of ORMD-0801, namely,
replication of normal physiology of insulin secretion and
absorption through the portal vein followed by direct delivery to
the liver leading to an effective treatment with less risk of
hypoglycemia and weight gain.
Comments by Dr. Fleming:
- ORMD-0801 demonstrated an excellent safety profile,
specifically with regards to hypoglycemic events as compared to
other insulin products on the market today, for which hypoglycemia
is a major risk.
- Dosing at night addresses a major challenge of type 2 diabetes:
People with the disease generally awake in the morning at a
metabolic disadvantage. By improving night-time glucose levels, a
person with diabetes can start the day with improved metabolic
condition, which enables better control of blood glucose levels
throughout the day.
- The key advantage of Oramed's oral insulin is its ability to
safely deliver insulin in a more physiologic manner. While
convenience is a benefit of oral administration, the most important
benefit by far is a safer way to give insulin therapy.
Comments by Dr. Neutel:
- The goal of this Phase IIb study was to gather information for
next year's anticipated Phase III trial.
- The primary endpoint, reduction in HbA1c compared to placebo at
week 12, was achieved. 32mg of ORMD-0801 administered orally once a
day demonstrated a reduction of 0.54, after adjusting for placebo,
with a statistically significant p-value of 0.036.
- Significant safety outcomes included no increase in adverse
events when compared to placebo, no increase in hypoglycemic events
when compared to placebo, and no weight gain when compared to
placebo.
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 (PODTM) 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 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, which has potential to
be the first orally-ingestible GLP-1 analog.
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 safety and
efficacy of ORMD-0801, the ability of ORMD-0801 to reduce HbA1c,
the potential uses and advantages of ORMD-0801 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
Oramed Pharmaceuticals
Estee Yaari
Office: +972-2-566-0001
US: +1-844-9-ORAMED
Email: estee@oramed.com
View original
content:http://www.prnewswire.com/news-releases/oramed-provides-highlights-and-data-from-its-phase-iib-oral-insulin-study-investor-event-300960981.html
SOURCE Oramed Pharmaceuticals Inc.