- Completed recruitment and randomization of all patients in the
primary cohort of Phase IIb HbA1c trial for oral insulin
capsule ORMD-0801, potentially the first commercial oral insulin
capsule for the treatment of Type 2 diabetes; results expected in
4Q 2019; following results Oramed plans to initiate end of Phase II
meeting with FDA to plan for Phase III
- Initiated second low dose cohort in Phase IIb HbA1c
trial for oral insulin capsule ORMD-0801 to evaluate
potential efficacy of lower doses; results expected in 1Q 2020
- Evaluating results of Phase I PK study of oral GLP–1
analog ORMD-0901 to assess options for supplemental
studies
- Examination of ORMD-0801 underway for the treatment of
nonalcoholic steatohepatitis (NASH) patients
- Clinical trial for oral leptin capsule for weight loss
initiated
NEW YORK, June 18, 2019 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), a
clinical-stage pharmaceutical company focused on the development of
oral drug delivery systems, today provided a clinical update
regarding four ongoing clinical programs.
"All of our clinical programs continue to advance on-track as
planned with no related serious adverse safety issues. We expect to
provide meaningful clinical results from these ongoing trials in
the coming months," stated Oramed CEO, Nadav Kidron. "We believe we have a
unique oral technology platform that has the potential to
revolutionize the effective delivery of important medication to
improve treatment of diabetes and related conditions."
Oral Insulin:
In mid-May, Oramed completed enrollment and randomization
of close to 300 patients in the primary cohort for its 90-day
dose-ranging Phase IIb HbA1c clinical study of its oral
insulin capsule, ORMD-0801, for Type 2 diabetes.
Over 80% (237 patients) of these patients have
completed treatment in the study.
The Phase IIb double-blind, randomized study for Type 2 diabetes
is designed to identify the optimal dose to take into Phase III
evaluation. The Phase IIb study will assess the primary efficacy
endpoint of reduction in HbA1c as well as safety endpoints. Study
results for the primary cohort are expected by year-end 2019.
Following the results of the primary cohort Oramed plans to
initiate an end of Phase II meeting with the FDA to discuss Phase
III protocol.
In addition, Oramed initiated a secondary cohort of patients
within the 90-day Phase IIb HbA1C clinical study to evaluate
potential efficacy of ORMD-0801 at lower doses. The results are
expected in 1Q 2020.
GLP-1:
Oramed completed its Phase I pharmacokinetic (PK) study for
ORMD-0901, its oral glucagon-like peptide-1 (GLP-1) analog of
exenatide capsule for Type 2 diabetes. This is the first study of
ORMD-0901 under Oramed's existing FDA Investigational New Drug
application (IND). It is a randomized, single-blind,
placebo-controlled, crossover study that aims to evaluate the
safety, in addition to the pharmacokinetics, of ORMD-0901 compared
to placebo and to open-label subcutaneous exenatide (an
FDA-approved GLP-1 analog currently on the market) in 16 healthy
subjects. Oramed is now assessing the results for future study
options. Previous small studies have shown positive
trends.
NASH
Oramed is conducting an exploratory clinical trial with
ORMD-0801 for the treatment of nonalcoholic steatohepatitis (NASH).
Prevalence of NASH is accelerating rapidly and correlates directly
with the rising incidence of Type 2 diabetes. The exploratory
3-month NASH study is ongoing, and Oramed expects to conclude the
first cohort by 4Q 2019.
Oral Leptin
Oramed is conducting an exploratory trial with an oral leptin
capsule to evaluate glucagon reduction in Type 1 diabetes,
with a long-term goal of addressing weight loss.
Leptin, known as the "obesity hormone," is a protein that
regulates hunger. Obesity and diabetes are highly
correlated.
Oramed's proof-of-concept, single-dose study
examining glucagon reduction, the first in humans, is planned
to begin in 3Q 2019. The study will enroll 10 patients with Type 1
diabetes.
Study results are expected in 4Q 2019.
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 that is based on more
than 30 years of research by scientists at Jerusalem's Hadassah Medical Center. 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 Type 2 and Type 1 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, which has
potential to be the first orally-ingestible GLP-1 analog.
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 timing of expected
clinical development programs and clinical trials, including
patient enrollment, release of results, recruitment of additional
cohorts or revolutionizing the treatment of diabetes with our
products. 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
Oramed Pharmaceuticals
Estee Yaari
Office: +972-2-566-0001
US: +1-877-9-ORAMED
Email: estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.