NEW
YORK, Jan. 11, 2023 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), a clinical-stage
pharmaceutical company focused on the development of oral drug
delivery platforms, announced today top-line results from its Phase
3 randomized, double-blind, placebo-controlled, multicenter
clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to
placebo in patients with Type 2 Diabetes (T2D) at 26 weeks.
ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic
control on two or three oral glucose-lowering agents.
The ORA-D-013-1 trial did not meet its primary endpoint, which
compared the efficacy of ORMD-0801 to placebo in improving glycemic
control as assessed by the mean change from baseline in A1C at 26
weeks. The trial also did not meet its secondary endpoint, which
assessed the mean change from baseline in fasting plasma glucose at
26 weeks. There were no serious drug-related adverse events.
Therefore, Oramed expects to discontinue its oral insulin clinical
activities for T2D.
Nadav Kidron, Oramed's Chief
Executive Officer, commented, "Today's outcome is very
disappointing, given the positive results from prior trials. Once
full data from the studies are available, we expect to share
relevant learnings and future plans. We thank all the patients,
families and healthcare professionals who participated in the
trial."
Additional Information About the ORA-D-013-1 Phase 3 Clinical
Trial
In the ORA-D-013-1 trial, patients were randomized 2:2:1:1 into
four groups: 8 mg dosed once-daily; 8 mg dosed twice-daily; placebo
dosed once-daily; and placebo dosed twice-daily. Patients completed
an initial 21-day Screening Period, followed by a 26-week
Double-Blind Treatment Period. More information on the trial can be
found here: ORA-D-013-1.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/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 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
our future strategy, plans and prospects, providing further
clinical and business updates based on additional analyses, and our
discontinuation of clinical trial activities for ORMD-0801. 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 risk that the Company may not be able to successfully
implement its strategic plans; the risks and uncertainties related
to the progress, timing, cost, and results of current and future
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; that products may
harm recipients; and other factors discussed in the "Risk Factors"
section of the Company's most recent Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q, each of which is on file with the
Securities and Exchange Commission and in other filings that the
Company makes with the Securities and Exchange Commission in the
future. All of these factors and uncertainties 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.