- Recruiting and Dosing Patients Across Growing Number of
U.S. Sites in Phase 3 Oral Insulin Trial
- Clinical Advancements in NASH & Leptin
- Discussions with Potential Partners Under
Way
- To view a video message from the CEO, click
here
NEW YORK, Jan. 27, 2021 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com),
a clinical-stage pharmaceutical company focused on the development
of oral drug delivery technology, is pleased to provide the
following Letter to Shareholders from Chief Executive Officer
Nadav Kidron.
Dear Shareholders,
We begin 2021 with new hope as vaccines and treatments essential
to returning our global community to a new, and better normal are
rolling out. During 2021, we are focused on achieving
significant advancements with the world's first pivotal Phase 3
oral insulin trial conducted through an FDA approved
protocol. We're excited by the progress being made in
bringing oral insulin to fruition.
Phase 3 Oral Insulin: Enrolling and Randomizing
Patients
The FDA approved Oramed's two double blind, placebo controlled,
multicenter protocols which will evaluate our oral insulin
(ORMD-0801) in type 2 diabetes (T2D) as follows:
- ORA-013-1: Evaluation of efficacy and safety of
ORMD-0801 in 675 subjects in the U.S. who have inadequate glycemic
control and are currently taking two or three oral glucose-lowering
agents
- ORA-013-2: Evaluation of efficacy and safety of
ORMD-0801 in 450 subjects in the U.S., Europe, and Israel who have inadequate glycemic control
and are on diet modification without medication, or on metformin
monotherapy
- In November 2020, we initiated
screening patients for ORA-013-1, and we continue to screen and
randomize patients at a growing number of sites in the United States, making ORMD-0801 the first
insulin capsule to enter Phase 3 trials in the U.S. under an FDA
approved protocol. We look forward to sharing recruitment numbers
later in Q1 2021 and plan to provide updates as we reach enrollment
milestones.
- Efficacy data from the trials will become available after
patients have completed the first 6 months of treatment. Safety
will be further monitored as patients will be exposed to the drug
over an additional 6 months. The trial's topline results are
expected in 2022.
Oral Insulin: NASH Phase 2 Initiated
We are enrolling patients in our global Phase 2 nonalcoholic
steatohepatitis (NASH) study which was initiated in December 2020 when the first patients were
screened in the U.S. Additional clinical sites in Europe and Israel are expected to begin recruitment later
in Q1 2021. The trial will measure efficacy endpoints via
MRI- derived proton density fat fraction (MRI-PDFF) for 12 weeks,
as well as percent change in liver fibrosis and liver steatosis. We
anticipate completing this NASH study in 2021.
Data from our pilot study of ORMD-0801 in diabetic patients with
NASH showed impressive results, including a 30% relative reduction
in fatty liver content, as measured by MRI-PDFF.
Gamma-glutamyltransferase (GGT), a key marker of chronic hepatitis,
and fasting insulin levels were both significantly lower after 12
weeks of treatment as compared to baseline. The study found
ORMD-0801 was safe and well tolerated in this patient
population.
Oral GLP-1 and Leptin: Additional Studies Expected in
2021
This year we anticipate initiating a bioavailability study for
ORMD-0901, our oral glucagon-like peptide-1 (GLP-1) analog capsule,
in T2D patients. A prior Phase 1 pharmacokinetic (PK) study showed
ORMD-0901, in healthy volunteers, preserved the biological
activity of orally delivered GLP-1 and curbed blood sugar
excursions following glucose challenge. An effective GLP-1 analog,
in addition to decreasing blood glucose levels, can also reduce
HbA1c, preserve beta cell function, and promote weight loss.
In 2020, we conducted an exploratory oral leptin trial to
evaluate glucagon reduction in type 1 diabetes (T1D). Leptin
is a protein that regulates hunger and is of interest to us as a
potential addition to our clinical development platform. The
proof-of-concept study evaluated the pharmacokinetic and
pharmacodynamics of our oral leptin drug candidate in adult T1D
patients and showed that patients who received leptin, on average,
had a decrease in glucose as compared to the placebo group during
the first 30-180 minutes following dosing. We anticipate initiating
a larger double-blind, placebo-controlled study for our oral leptin
capsule later this year.
I am pleased to confirm that we entered 2021 with a strong
balance sheet and solid financial position which allows us to move
forward on all fronts. From this position of strength, we are
holding discussions with potential partners and collaborators
across the globe.
All of us at Oramed wish you and yours good health.
Sincerely,
Nadav Kidron
Chief Executive Officer
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 expected recruitment
and enrollment for our trials and studies, the expected timing of
initiating and completing our trials and studies, the potential for
FDA approval of our oral insulin, our expectation that we have
enough cash to move forward, expected updates regarding future
milestones, potential safety and toleration and efficacy of
ORMD-801, the validation of preliminary findings in future trials,
discussions with potential partners and collaborators, 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.
Company Contact
Estee Yaari
+1-844-9-ORAMED Ext: 2
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.