NEW YORK, Oct. 16, 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, is pleased to provide the following
Shareholder Update from Chief Executive Officer Nadav Kidron.
Dear Shareholders,
We are pleased to announce that based on guidance received from
the U.S. Food and Drug Administration (FDA) as part of the
End-of-Phase 2 meeting process for our oral insulin candidate,
ORMD-0801, we have submitted to the FDA the protocols for our
upcoming pivotal Phase 3 studies. In line with the FDA's
expectations and recommendations, we intend to conduct two Phase 3
studies concurrently in patients with type 2 diabetes (T2D). These
studies involve about 1,125 patients to provide evidence of
ORMD-0801's safety and efficacy in T2D patients over a treatment
period of 6 to 12 months. A geographically diverse patient
population will be recruited from multiple sites throughout the
U.S., European Union countries, and Israel.
As agreed with the FDA, our ORA-D-013-1 study will treat T2D
patients with inadequate glycemic control who are currently on 1, 2
or 3 oral glucose-lowering agents. This U.S. study will recruit 675
patients from 75 clinical sites located throughout the U.S.
Patients will be randomized 1:1:1 in this double-dummy study into
cohorts of: 8 mg ORMD-0801 once-daily at night and placebo 45 mins
before breakfast; 8 mg ORMD-0801 twice-daily, at night and 45 mins
before breakfast; and placebo twice-daily, at night and 45 mins
before breakfast. The primary endpoint of the study is to evaluate
the efficacy of ORMD-0801 compared to placebo in improving glycemic
control as assessed by A1c, with a secondary efficacy endpoint of
assessing the change from baseline in fasting plasma glucose at 26
weeks.
The ORA-D-013-2 study will include T2D patients with inadequate
glycemic control who are managing their condition with either diet
alone or with diet and metformin monotherapy. A total of 450
patients will be recruited through 36 sites in the U.S. and 25
sites in Western Europe and
Israel. Patients will be
randomized 1:1 into two cohorts dosed with: 8 mg ORMD-0801 at
night; and placebo at night. The primary endpoint is to evaluate
the efficacy of ORMD-0801 compared to placebo in improving glycemic
control as assessed by A1c over a 26-week treatment period, with a
secondary efficacy endpoint of assessing the change from baseline
in fasting plasma glucose at 26 weeks.
We plan to commence patient enrollment for both studies this
quarter and expect efficacy data to be available after all patients
have completed the 6-month treatment period. If we
successfully complete the pivotal studies, we expect to conduct a
pre-BLA (Biologics License Application) meeting to finalize the
plans and data for the BLA submission. After BLA submission
and review, if the BLA is approved, a full 12 years of marketing
exclusivity would be granted. Oramed is committed to advancing the
science and clinical development of oral insulin, as we believe it
can deliver meaningful benefits to patients' quality of life and
significantly enhance the treatment of diabetes.
Wishing 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 2 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
efficacy of ORMD-801, the validation of preliminary findings in
future trials, the potential timing of enrollment for our studies
and release of related data, the potential benefits of ORMD-0801,
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
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.