NEW YORK, Jan. 9, 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
letter to shareholders from Chief Executive Officer Nadav Kidron. For a video message from Mr.
Kidron click here.
Dear Shareholders,
2019 was a great year of progress for Oramed. We are excited to
report that the U.S. Food and Drug Administration (FDA) has agreed
to an End of Phase 2 Chemistry Manufacturing and Control (CMC)
meeting on February 4, 2020. We
expect additional meetings with both the FDA and the European
Medicines Agency (EMA), during which we anticipate receiving the
regulatory agencies' guidance on our Phase 3 study design. We
believe this milestone is the culmination of the hard work and
dedication of our employees and investors, and positions us closer
to achieving our goal of developing the world's first oral insulin
capsule for the treatment of diabetes.
2019 Major Milestones Achieved
- ORMD-0801 successfully met its primary endpoint of HbA1C
reduction and demonstrated an excellent safety profile in a Phase
2b trial in type 2 diabetes
- Initiated second cohort of Phase 2b trial to evaluate efficacy and safety of
ORMD-0801 in lower dosage in type 2 diabetes
- Initiated a study of ORMD-0801 in type 1 diabetes to determine
dose in advance of our Phase 3 study which will be conducted in
both type 1 and type 2 diabetes
- FDA granted an End of Phase 2 CMC meeting
2020 Major Anticipated Milestones
- ORMD-0801 (oral insulin)
-
- Results from Phase 2b secondary
cohort in type 2 diabetes (Q1)
- Results from dosing study in type 1 diabetes (Q1)
- Meetings with FDA and EMA in advance of pivotal Phase 3 study
(H1)
- Phase 3 pivotal diabetes (HbA1c) study initiation (H2)
- NASH clinical study data (Q1)
- ORMD-0901 (oral GLP-1)
-
- Complete bioavailability study in type 2 patients
- Leptin Phase 1 clinical study completion (Q1)
Oral Insulin (ORMD-0801)
We are extremely pleased with the results from our successful
placebo-controlled, double-blind, randomized, 90-day dose-ranging
Phase 2b trial in type 2 diabetes.
ORMD-0801 demonstrated an exceptionally clean safety profile with
no serious drug-related adverse events, no weight gain, and
successfully met the primary endpoint with statistically
significant reductions in A1C. Our lower dose cohort study
aims to identify the optimal dose for our Phase 3 trial and we are
pleased to announce the last patient out in this study. We
anticipate announcing results in the first quarter of 2020.
Consistent with our strategy to further our clinical trials in
an optimal fashion, the FDA has agreed to hold an initial End of
Phase 2 (CMC) meeting on February 4,
2020. A second End of Phase 2 meeting for clinical design
(clinical) meeting is expected following the release of data from
the low dose cohort of the Phase 2b
trial. We also expect to have a meeting with the EMA regarding our
Phase 3 study design, as we intend to have some clinical sites in
Europe and file for marketing
approval in Europe.
Our Phase 3 study will evaluate ORMD-0801 in both type 1 and
type 2 diabetes. The dosing study in type 1 diabetes that we
initiated in 2019, with results expected in the first quarter of
2020, will inform our study design.
GLP-1 (ORMD-0901)
We expect to conduct further bioavailability studies of
ORMD-0901 in type 2 diabetic patients. Results are expected later
this year.
NASH Exploratory Clinical Study
The NASH exploratory clinical study of ORMD-0801 in the
treatment of chronic liver disease will assess the efficacy of
ORMD-0801 in reducing liver fat content, inflammation, and fibrosis
in 30 patients with NASH. We expect initial results from the
first group of patients in the first quarter of 2020.
Leptin Exploratory Clinical Study
We expect to initiate a proof of concept single dose study,
evaluating the pharmacokinetic and pharmacodynamics of our oral
leptin drug candidate in 10 type 1 adult diabetic patients. We
anticipate completing this study during the first quarter
of 2020.
Chinese Partnership
To date, we have received a total of $33 million in
payments from China-based
HTIT and expect an additional $17
million upon the achievement of additional milestones.
HTIT has initiated clinical trials of ORMD-0801 in
China.
We are excited to build upon all the progress we made in 2019
and believe that 2020 will be a very productive and event driven
year. We look forward to continuing the advancement of our clinical
programs, particularly the initiation of a Phase 3 trial for
ORMD-0801, which we believe positions Oramed to be the first to
offer an oral insulin capsule for the treatment of
diabetes.
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 (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.
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 expected timing of
initiation and completion of and release of data from clinical
trials, expected meetings with the FDA, the safety and efficacy of
ORMD-0801, the ability of ORMD-0801 to reduce A1C, expected
additional payments from HTIT, 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
Email: estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.