NEW YORK, November 12, 2019 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), a clinical-stage
pharmaceutical company focused on the development of oral drug
delivery systems, today announced positive results from the initial
cohort of the Phase IIb trial evaluating the efficacy and safety of
its lead oral insulin candidate, ORMD-0801, which has the potential
to be the first commercial oral insulin capsule for the treatment
of diabetes.
The placebo-controlled, double-blinded, randomized, 90-day
dose-ranging phase IIb trial in type 2 diabetes (T2D) patients with
inadequate glycemic control on oral antihyperglycemic agents,
assessed the change in A1C, the primary efficacy endpoint, from
baseline to week 12, as well as safety endpoints, when ORMD-0801
was given in different regimens across a dose range.
Patients randomized in the trial to
once-daily ORMD-0801 achieved a reduction in mean A1C of
0.60% from baseline, or a reduction of 0.54% adjusted
for placebo (p value = 0.036). This 0.54% reduction in
A1C is considered clinically meaningful, reflecting an improved
glucose control that would result in reduced risk of developing
diabetes-related complications.
Treatment with ORMD-0801 demonstrated an excellent safety
profile, with no serious drug-related adverse events and with no
increased frequency of hypoglycemic episodes. In addition, during
this 90-day trial, no weight gain was observed.
Oramed's Chief Executive Officer, Nadav
Kidron, said, "These results further demonstrate that
ORMD-0801 is a safe and efficacious insulin treatment for
improving disease management for the millions of people
living with diabetes. As a next step, we look forward to the
read-out of data from a second cohort of the trial in the
first quarter of 2020 and further discussions with the U.S. FDA
about Phase III trials. We are enthusiastic about ORMD-0801's
potential as we transition into the final stages of
development."
Joel M. Neutel, MD, the Principal Investigator of the Phase
IIb trial of ORMD-0801, commented, "This Phase IIb study provides
statistically significant efficacy data which, coupled with
no reported hypoglycaemia, support a unique mechanism of action of
Oramed's oral insulin. The intestinal absorption of insulin enables
direct delivery of insulin to the liver mimicking the natural
transport of insulin in the body. The result is a more
physiologic replacement of insulin, leading to an effective
treatment with less risk of hypoglycaemia and weight
gain. Based on these positive results and the demonstrated
meaningful reduction in A1C in T2D patients, with inadequate blood
glucose control, many of whom were on multiple diabetes
medications, I believe the use of ORMD-0801 could be clinically
beneficial to patients." Dr. Neutel is the Director of Research at
Orange County Research Center in Tustin,
California.
A teleconference call will be held today, Tuesday, November 12, 2019, at 8:30 a.m. ET. The dial-in numbers for the
conference call are 1-866-966-1396 for domestic callers and +44 (0)
207-192-8000 for international callers. The conference ID is
1288697.
On November 18, 2019, Oramed will
host an investor event and an additional teleconference call to
further review the data details of its ORMD-0801 Phase IIb trial.
The dial-in numbers for the additional conference call are
1-866-966-1396 for domestic callers and +44 (0) 207-192-8000 for
international callers. The conference ID is 9469607. To
view the slides and hear the presentation connect at
https://webconnect.webex.com/webconnect/onstage/g.php?MTID=ea5e270cfeb418bfbd1fa7b53824a26c7
About ORMD-0801 Phase IIb Study
The Phase IIb study was a 90-day, double-blind, randomized,
multi-center trial designed to evaluate the safety and efficacy of
ORMD-0801 as a treatment for patients with Type 2 diabetes. The
primary efficacy endpoint was a reduction in Hemoglobin A1c (A1C,
also known as HbA1c, is a key clinical measure of blood sugar
control) at Week 12.
In the initial cohort, 269 U.S. based patients were enrolled and
treated with a dose-increasing approach: 16 mg initial dose,
titrated to 24 mg per dose, and then titrated to 32 mg per dose.
Patients were randomized into three groups to assess dosing
frequency: once-daily (32mg per day), twice-daily (64mg per day),
thrice-daily (96mg per day). There was a corresponding placebo for
each treatment arm. Two hundred nine (209) patients completed
treatment to the 12-week endpoint and were included in the data
analysis (24 subjects did not complete the full 12 weeks of
treatment). In addition, due to the evidence of
treatment-by-center interaction, two sites (36 patients
(13.4% of enrolled subjects)) were excluded from the statistical
analysis.
The once-daily and twice-daily arms achieved statistically
significant (p-value 0.036 and 0.042, respectively) reductions from
baseline in A1C of 0.60% ( 0.54% with placebo adjustment ) and
0.59% ( 0.53% with placebo adjustment ) respectively. The
thrice-daily arm did not meet statistical significance (p-value
0.093). ORMD-0801 demonstrated an excellent safety profile with no
serious drug-related adverse events.
The ongoing second cohort is designed with a sample size of 15
subjects per treatment group to identify the optimal dose of
ORMD-0801 for the Phase III trial. In the low-dose second cohort,
75 patients have been randomized into five groups: 8 mg dosed
once-daily; 8 mg dosed twice-daily; 16 mg dosed once-daily; 16 mg
dosed twice-daily; and placebo dosed twice-daily. Oramed expects to
announce the results from the second cohort in Q1 of 2020.
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 (PODTM) 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 potential of
ORMD-0801 to be the first commercial oral insulin capsule for the
treatment of diabetes, the safety and efficacy of ORMD-0801, the
ability of ORMD-0801 to reduce A1C, 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. 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:
Oramed
Pharmaceuticals
Estee Yaari
Office: +972-2-566-0001
US:+1-844-9-ORAMED
Email: estee@oramed.com
View original
content:http://www.prnewswire.com/news-releases/oramed-announces-successful-phase-iib-study-of-oral-insulin-in-type-2-diabetes-300956274.html
SOURCE Oramed Pharmaceuticals Inc.