- Primary endpoint met: ORMD-0801 was safe and well
tolerated
- Secondary endpoint met: ORMD-0801 showed clinically
meaningful reduction of liver fat from baseline at 12
weeks
- Strong evidence for treatment of NASH using Oramed's oral
insulin
NEW
YORK, Sept. 13, 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 platforms, announced today positive Phase 2
results from its double-blind, fully randomized,
placebo-controlled, multicenter trial to assess the safety and
efficacy of its oral insulin candidate (ORMD-0801), to reduce liver
fat content in Type 2 Diabetes ("T2D") patients with non-alcoholic
steatohepatitis ("NASH").
The 12-week trial enrolled 32 patients (with 30 patients
completing) and 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.
"These results paint an exciting picture for the potential of
our oral insulin candidate to treat patients with both diabetes and
NASH, a very serious condition with few treatment options," said
Oramed's Chief Executive Officer, Nadav
Kidron. "At the same time, we await the top-line data from
our Phase 3 trial of oral insulin for T2D, which we expect in
January 2023."
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 who were administered either
placebo (11 patients) or ORMD-0801 8 mg twice daily (one capsule in
the morning, prior to breakfast, and one capsule at night) (21
patients) for 12 weeks.
About NASH
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. Currently, no pharmacotherapy is
globally approved for the treatment of NASH, and people with NASH
are left with very few treatment options.
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 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 potential safety and
efficacy of ORMD-0801 to reduce liver fat content in T2D patients
with NASH, the timing of results of our clinical trials 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.