NEW YORK, Feb. 26, 2020 /PRNewswire/ --
- Primary endpoints successfully met
- Results confirm significant clinical benefits of ORMD-0801 at
lower dose treatment
- 0.95% (0.81% placebo adjusted) A1C reduction in patients
treated once daily at 8mg
- Excellent safety profile
- Paves the way for FDA discussions on Phase 3 Study
- Conference Call to Review Results Today at 2:00 p.m. ET
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP), a
clinical-stage pharmaceutical company focused on the development of
oral drug delivery systems, today announced positive topline data
from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety of
its lead oral insulin candidate, ORMD-0801, at lower dose regimens.
ORMD-0801 has the potential to be the first commercially available
oral insulin capsule for the treatment of diabetes.
The placebo-controlled, double-blinded, randomized, 90-day
dose-ranging Phase 2b trial in type 2
diabetes 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
three daily dose ranges (8 mg, 16 mg, 32 mg).
Patients randomized in the trial treated with 8 mg of ORMD-0801
once daily achieved an observed mean reduction of 1.29% from
baseline and a least square mean reduction of 0.95% from baseline,
or 0.81% adjusted for placebo (p value = 0.028). Patients who
had A1C readings above 9% at baseline and received 8 mg of oral
insulin once daily experienced a 1.26% reduction in A1C by week
12.
Treatment with ORMD-0801 at all doses demonstrated an excellent
safety profile, with no serious drug-related adverse events and no
increased frequency of hypoglycemic episodes or weight gain
compared to placebo. The topline data from the second cohort
represents the conclusion of the Phase 2b trial, and the company believes that the
results now pave the way for FDA discussions regarding the
initiation of a Phase 3 trial.
A teleconference call will be held today, Wednesday, February 26, 2020 at 2 p.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 6468688. To view the slides and hear the presentation
connect
at https://webconnect.webex.com/webconnect/onstage/g.php?MTID=e6bfa5a6ceeefb49d48caf1a17f6bf4ef.
Oramed's Chief Executive Officer, Nadav
Kidron, stated, "We believe the strong efficacy shown while
treating patients at a lower dose further demonstrates ORMD-0801's
potential as a safe, non-invasive, and effective oral insulin
solution for the millions of people suffering from diabetes
worldwide. Following this conclusion of our Phase 2b trial, we are excited to further discuss with
the FDA our planned Phase 3 trial."
Joel M. Neutel, MD, the Principal Investigator of the
ORMD-0801 Phase 2b trial, commented,
"The statistically significant efficacy data, coupled with a clean
safety profile, characterized by no reported weight gain, no
increase in serious drug-related adverse events, and no
hypoglycemia, further support ORMD 0801's clinical potential. I
believe the data demonstrated in this second cohort further
validates the clinical potential of Oramed's oral insulin to have a
highly beneficial impact on the treatment of diabetes the world
over. The combined first and second cohort data for the lower
doses illustrates that a lower dose would seem to be the right
dosage level for future Phase 3 trials, and that in this case, less
is more."
About ORMD-0801 Phase 2b Trial
Second Cohort
The second cohort of the Phase 2b
trial was a 90-day, double-blind, randomized, multi-center trial
designed to evaluate the safety and efficacy and determine an
optimal dose 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, a key clinical measure of
blood glucose control) at week 12.
In this second cohort, 78 U.S.-based patients were enrolled,
treated, and 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 once-daily. The same two sites
which were excluded from the statistical analysis in the primary
cohort due to evidence of treatment‐by‐center interaction and a
statistically significant placebo effect, were excluded in the
second cohort, representing a patient population of 13 patients. Of
the 65 patients included in the analysis, 57 completed through week
12.
The once-daily and twice-daily arms of patients dosed at 8 mg
achieved statistically significant (p-value 0.028 and 0.029,
respectively) reductions from baseline in A1C of 0.95% (0.81% with
placebo adjustment) and 0.95% (0.82% with placebo adjustment),
respectively. Patients dosed once-daily at 16 mg and twice-daily at
16 mg did not show statistically significant reductions in A1C.
ORMD-0801 demonstrated an excellent safety profile with no
serious drug-related adverse events, hypoglycemia or weight
gain.
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 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 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, the clinical potential of
Oramed's oral insulin to have a highly beneficial impact on the
treatment of diabetes the world over, the timing of expected
clinical development programs and clinical trials and discussions
with the FDA 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
Email: estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.