- Achieved primary endpoint of safety and tolerability in
participants with Type 2 diabetes with NASH.
- Oral insulin candidate demonstrates consistent trends across
key secondary endpoints with reduction of liver fat, liver
stiffness and lipids.
- Key opinion leaders' discussion highlights new data and is
available on demand.
NEW
YORK, Nov. 17, 2022 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP), a clinical-stage
pharmaceutical company focused on the development of oral drug
delivery platforms, today announced additional positive data from
its Phase 2 double-blind, fully randomized, placebo-controlled,
multicenter clinical trial (ORA-D-N02) to assess the safety and
efficacy of its oral insulin candidate (ORMD-0801), to reduce liver
fat content in Type 2 Diabetes patients with non-alcoholic
steatohepatitis ("NASH"). The presentation of this new data,
including a discussion by key opinion leaders, was featured in a
webinar today with a replay available on Oramed's website under
Events and Presentations.
Professor Yaron Ilan, M.D.,
Director of the Department of Medicine at the Hebrew University-Hadassah Medical Center, and
principal investigator for the clinical trial, commented, "The
clinical data scientific results of ORMD-0801 demonstrated positive
safety results on key liver-related endpoints such as reduction of
fat and fibrosis. In this patient population, the safety of a
potential therapy is of paramount importance."
"We are very encouraged by the detailed data reported today
demonstrating a positive safety profile and signs of efficacy for
our oral insulin program to treat NASH," said Oramed's Chief
Executive Officer, Nadav Kidron. "We
also saw consistent trends across key secondary endpoints. This
indicates that our oral insulin may be an ideal treatment option
for the millions of diabetes and NASH patients, as the global
market for drugs to treat NASH is expected to reach $84 billion by 20291. Using oral
insulin to treat NASH opens a world of possibilities."
Phase 2 Trial Results
As previously announced, the
Phase 2 trial enrolled 32 patients (with 30 patients completing)
over a treatment period of 12-weeks. The trial demonstrated that
ORMD-0801 was safe and well tolerated at 8 mg twice daily dosing,
meeting the primary endpoint of no difference in adverse events for
ORMD-0801 compared to placebo. The trial also evaluated the
effectiveness of ORMD-0801 in reducing liver fat content over the
12-week treatment period by observing several independent measures.
These measurements included MR PDFF (%) as measured by MRI,
Steatosis and Fibrosis as measured by Fibroscan, Lipids and HbA1c.
All the measurements showed a consistent clinically meaningful
trend in favor of ORMD-0801.
Safety Data Summary
- Primary objective of safety met with no serious adverse events
and no difference in the incidence rate of adverse events between
ORMD-0801 and placebo.
Efficacy Data Summary
Overall, the Phase 2 trial
achieved the proof of concept that ORMD-0801 may be a potential
candidate for the reduction in liver fat and stiffness and lipids
in patients with T2D and NASH.
- Secondary objective of reducing liver fat content in patients
with NASH and T2D (Percent Change from Baseline to Week 12 in MR
PDFF (%):
- Whole Liver showed a placebo adjusted mean decrease of 0.96 with
a placebo adjusted median decrease of 6.0 for ORMD-0801.
- Exploratory objective of median change from baseline in
Fibroscan fibrosis levels:
- Median Change from Baseline to Week 12 in Fibrosis
Median (kPa) showed a placebo adjusted median decrease of 1.1
for ORMD-0801.
- Median change from Baseline to Week 12 in Steatosis
Median (dB/m) showed a placebo adjusted median
decrease of 29 for ORMD-0801.
- Exploratory objective of change from baseline in Lipid
levels:
- Mean Change from Baseline to Week 12 in Total Cholesterol
(mmol/L) showed a placebo adjusted mean decrease
of 0.40 for ORMD-0801.
- Results were similar for LDL, HDL
and Triglycerides.
About the Trial
ORA-D-N02 is a Phase 2 double-blind,
randomized, placebo-controlled, multicenter trial to assess the
safety and efficacy of Oramed's oral insulin candidate, ORMD-0801,
to reduce liver fat content in T2D patients with NASH. The trial's
primary endpoint was to evaluate the safety of oral insulin in
patients with NASH and T2D, with a secondary endpoint to assess,
non-statistically, ORMD-0801's efficacy in reducing liver fat
content in patients with NASH and T2D. The trial recruited 32
patients with a diagnosis of T2D and of NAFLD by non-invasive
determination of hepatic steatosis grade S1, defined as hepatic
steatosis > 8% by MRI-PDFF and CAP FibroScan ≥ 238 dB/m. The
patients were administered either placebo (n=11) or ORMD-0801 8 mg
twice daily (one capsule in the morning, prior to breakfast, and
one capsule at night) (n=21) for 12 weeks.
About NASH
Nonalcoholic steatohepatitis (NASH) is a
serious, progressive liver disease caused by a buildup of fat in
the liver and accompanied by inflammation, liver cell damage, and
in some cases, scarring of the liver. Over time, NASH may progress
to cirrhosis, liver cancer, liver failure, and even death. NASH is
the most common chronic liver disease and is associated with Type 2
diabetes in almost 60% of the cases2. Currently, no
pharmacotherapy is globally approved for the treatment of NASH, and
people with NASH are left with very few treatment options.
1 Source: Research and Markets report on the Global
Non-Alcoholic Steatohepatitis (NASH) Drugs Market.
2Source: Rev Med Suisse, 2020 Jun
10;16(697):1197-1199.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals
(Nasdaq/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 trials
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 potential safety and
efficacy of ORMD-0801 to treat diabetes and NASH, the expected
market for drugs to treat NASH, the potential of ORMD-0801 to be a
well-tolerated and convenient oral insulin product for the
treatment of patients with diabetes and NASH and 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.
Company Contact
Zach
Herschfus
+1-844-9-ORAMED
zach@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.