NEW YORK, June 15, 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 that its pilot study
of its oral insulin candidate ORMD-0801 in type 2 diabetes
patients with non-alcoholic steatohepatitis (NASH), has shown
ORMD-0801 to be safe and well tolerated thus far, with an
encouraging lowering of fatty liver content, as seen by
MRI- derived proton density fat fraction (MRI-PDFF).
The data is being presented in a poster at the 80th
American Diabetes Association (ADA) Scientific Sessions, held
virtually this year, June 12-16,
2020.
The pilot, open-label study of the first 8 patients of a planned
40-patient multi-center study, aimed to assess the safety,
tolerability, and early effects of 16 mg ORMD-0801 (2x8 mg
capsules) on liver fat in type 2 diabetes patients with NASH. The
12-week, once-daily treatment had no serious adverse events, and
induced an observed mean 6.9±6.8% reduction in liver fat content
(sign test p value: 0.035), and the relative reduction was 30%,
[see graph] as measured by MRI-PDFF. In parallel, concentrations of
gamma-glutamyltransferase (GGT), a key marker of chronic hepatitis,
were significantly lower after 12 weeks of treatment as compared to
baseline (-14.6±13.1 U/L; sign test p value: 0.008), as were
fasting insulin levels (-96.5±206.0 pmol/L; sign test p value:
0.035).
Oramed's CEO, Nadav
Kidron, said, "These preliminary observations suggest a
positive effect of oral insulin on NASH in people with type 2
diabetes, as shown by reductions in liver fat content. We look
forward to further validating these encouraging findings in the
larger population of this study and in large-scale, randomized
clinical trials."
In addition to the NASH data, Oramed is presenting two posters
illustrating ORMD-0801's impact on type-2 diabetes mellitus
(T2DM). Oramed's poster presentations at the ADA include:
- Oral Insulin (ORMD-0801) Effects on Glucose Parameters in
Uncontrolled T2DM on Oral Antibiotic Drugs (OADs), Presented by
Dr. Julio Rosenstock,
Director of the Dallas Diabetes Research Center and Scientific
advisory board member at Oramed Pharmaceuticals
- Oral Insulin–Induced Reduction in Liver Fat Content in T2DM
Patients with Nonalcoholic Steatohepatitis (NASH),
presented by Dr. Miriam
Kidron, Chief Scientific Officer at Oramed
Pharmaceuticals
- Evening Oral Insulin (ORMD-0801) Glycemic Effects in
Uncontrolled T2DM Patients, presented by Dr. Julio Rosenstock
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 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
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 potential safety and
toleration of ORMD-801, the validation of preliminary findings in
future trials, 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.
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Company Contact:
Estee Yaari
+1-844-9-ORAMED
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.