- Topline Pivotal Phase 3 Oral Insulin Data Expected
Mid-January 2023
- Phase 2 NASH Trial Achieved Primary and Secondary
Endpoints
- Definitive Deal Signed to Commercialize Oral Insulin in
South Korea
- $160 Million in Cash and
Investments (as of September 30,
2022)
NEW
YORK, Dec. 21, 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, today issued a Letter to
Shareholders from its Chief Executive Officer, Nadav Kidron.
Dear Shareholders and wider investor community,
The year 2022 was a very strong year for Oramed. The first of
our two Phase 3 oral insulin trials, ORA-D-013-1, completed
enrollment with a wider scope of patients than originally planned,
and we expect to announce topline results in mid-January 2023. Concurrently, our Phase 2 NASH
trial delivered positive efficacy and safety data. We finished out
the third quarter with $160 million
in cash and investments with no debt, giving us a long runway
through topline results for both of our Phase 3 oral insulin trials
and filing for U.S. Food and Drug Administration (FDA) approval of
ORMD-0801, potentially the world's first oral insulin capsule to
reach the market.
Phase 3 Oral Insulin Trials: Top-Line Data Expected
January 2023
ORA-D-013-1, the
first of our two pivotal Phase 3 oral insulin trials for ORMD-0801
in the treatment of type 2 diabetes met and exceeded the number of
planned participants, with 710 people enrolled. We expect to
announce topline results in the next four weeks. ORA-D-013-2, our
concurrent Phase 3 trial, continues to enroll the planned 450
patients, with enrollment expected to be completed in 2023.
Phase 2 NASH Trial Achieved Primary Endpoints
Our
Phase 2 double-blind, randomized, placebo-controlled, multicenter
clinical trial assessing the safety and efficacy of ORMD-0801 in
the treatment of non-alcoholic steatohepatitis ("NASH") in 32
patients with Type 2 diabetes and NASH achieved its primary
endpoint of safety and tolerability, demonstrating consistent
trends across key secondary endpoints with reduction of liver fat,
liver stiffness and lipids. We believe ORMD-0801 may be an ideal
treatment option for the millions of people living with both
diabetes and NASH. We held a Key Opinion Leader webinar in
November discussing the positive data and exciting potential of
Oramed's oral insulin candidate as a treatment option for this
indication. The full webinar can be viewed on the Oramed website.
There is currently no FDA approved treatment for NASH, which is
expected to become an $84 billion
market by 2029.
Definitive Deal with Medicox to Commercialize Oral Insulin in
South Korea
Continuing to build global partnerships, we signed an exclusive
commercial distribution agreement for South Korea with Medicox Co., Ltd. which will
have the exclusive license to apply for regulatory approval and
distribute ORMD-0801 for ten years in South Korea. Medicox will purchase ORMD-0801
at an agreed upon transfer price and will additionally pay Oramed
up to $18 million in developmental
milestones, $2 million of which has
already been received by Oramed, and up to 15% royalties on gross
sales in a large and growing diabetes market.
Phase 1 Oral COVID-19 Vaccine Trial Reported Positive
Preliminary Data
Our subsidiary Oravax's first cohort in its
Phase 1 clinical trial of our oral virus-like particle (VLP)
COVID-19 vaccine for COVID-naive participants achieved its primary
and secondary endpoints of safety and immunogenicity based on
preliminary data. Our oral vaccine elicited a potentially
protective IgG response with significant seroconversion from
baseline. We believe this trial shows proof of concept for oral
delivery of vaccines using Oravax's technology. Complete Phase 1
results are expected in the first quarter of 2023.
Oral GLP-1 Bioavailability Trial
ORMD-0901, our
oral glucagon-like peptide-1 (GLP-1) analog capsule,
is currently being evaluated under an FDA Investigational New Drug
(IND) application and we expect to issue an update
regarding the trial's progress in the coming weeks. GLP-1 is
an incretin hormone that stimulates the secretion of
insulin from the pancreas. Exenatide, a GLP-1 analog,
is currently available in injectable form only. An oral GLP-1 could
significantly increase compliance and become a valuable tool in the
treatment of diabetes.
We are entering 2023 with real excitement for what we believe
will be a monumental year for the Company. We thank you, our
shareholders, for your support and we thank our partners and trial
volunteers for helping advance our clinical and other efforts.
We wish you all a happy and healthy new year and look forward
to keeping all our shareholders updated on news and
developments.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals
(NASDAQ: ORMP) (TASE: ORMP) is a platform technology pioneer in the
field of oral delivery solutions for drugs currently delivered via
injection. The Company's novel Protein Oral Delivery (POD™)
technology is designed to protect drug integrity and increase
absorption. 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). Oramed has offices in the United States and Israel. 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 of
ORMD-0801 to be the first commercial oral insulin capsule for the
treatment of diabetes, the expected release of top-line data for
ORA-D-013-1, 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, the potential development of an oral COVID-19
vaccine, the pace of studies and trials for such oral vaccine and
the potential effectiveness, safety, immunogenicity and other
advantages of the vaccine against current and future coronavirus
strains or for the broader vaccines market, the potential for
regulatory approval or development of ORMD-0801 in South Korea or elsewhere, potential future
payments to Oramed from Medicox, including pursuant to milestone or
royalty payments and expected updates regarding ORMD-0901. 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.