- Primary and secondary endpoints of safety and
immunogenicity met
- Oral vaccine elicited a potentially protective IgG
response with significant seroconversion from baseline
- Trial shows proof of concept for oral delivery of
vaccines using Oravax technology
NEW
YORK, Oct. 7, 2022 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com),
a clinical-stage pharmaceutical company focused on the development
of oral drug delivery platforms, today announced that its
subsidiary, Oravax Medical Inc., reported positive preliminary data
from its Phase 1 trial of an oral Covid-19 vaccine candidate.
Preliminary Phase 1 trial results from the first cohort
include:
- Significant antibody response (2-6 fold over baseline) as
measured by multiple markers of immune response to VLP vaccine
antigens observed in majority of the patients dosed
- No safety issues observed, including mild symptoms
Oravax Medical is a clinical-stage vaccine company developing
oral vaccines that combine Oramed Pharmaceuticals' POD™ technology
with Premas Biotech's D-Crypt™ Platform. Oravax's oral Covid-19
vaccine candidate is designed using D-Crypt™ technology as a triple
antigen VLP vaccine that targets three major surface proteins of
the SARS-CoV-2 virus - Spike, Membrane and Envelope. This should
allow the oral vaccine candidate to trigger a protective response
not only against the prevalent strains of the SARS-CoV-2 virus, but
also the emerging mutations.
"We're very encouraged by this initial data, which indicates
that our platform can be safely and successfully used to orally
deliver protein-based vaccines," said Nadav
Kidron, Chairman of Oravax and CEO of Oramed
Pharmaceuticals.
"These results, together with the recent evolution of the Covid
strains, further raise our confidence in the success of an oral
Covid-19 vaccine and the broad potential of our platform along with
Oramed's POD™ platform to explore oral vaccines for other
infectious diseases," said Dr. Prabuddha
Kundu, Co-founder and Managing Director, Premas Biotech.
About the Trial
An open label, Phase 1, first-in-human, proof-of-concept, dose
escalation, dose-finding trial in up to 24 healthy volunteers. The
trial will evaluate the safety, tolerability, and immunogenicity of
two concentrations of Anti-SARS-CoV-2 vaccine administered orally
as a two-dose schedule, administered 21 days apart.
The first cohort of 12 eligible subjects received one capsule
containing the low dose on day 1 and a second oral dose on day 21.
The ongoing trial is to include an additional 12 subjects (subjects
13-24) who are to receive a high dose on day 1 and a second dose on
day 21.
Subjects will be monitored for safety, tolerability and antibody
titers for a period of 24 weeks after the first dose
administration. An end of trial visit will take place 24 weeks
after the first dose.
About Oravax
Oravax Medical Inc. was established in 2021 by Oramed
Pharmaceuticals Inc., the largest shareholder in Oravax, along with
Premas Biotech, MyMD Pharmaceuticals, and certain other
shareholders, with a mission to bring an oral Covid-19 vaccine to
the market. Oravax combines cutting-edge vaccine technology
acquired from Premas Biotech and the proprietary POD™ oral delivery
technology of Oramed Pharmaceuticals. For more information,
please visit www.ora-vax.com
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq: ORMP) (TASE: ORMP) is a
platform technology pioneer in the field of oral delivery solutions
for drugs currently delivered via injection. Established in 2006,
with offices in the United States
and Israel, Oramed has developed a
novel Protein Oral Delivery (POD™) technology. Oramed is seeking to
transform the treatment of diabetes through its proprietary lead
candidate, ORMD-0801, which is being evaluated in two pivotal Phase
3 studies and has the potential to be the first commercial oral
insulin capsule for the treatment of diabetes. 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
development of an oral Covid-19 vaccine, the pace of studies and
trials for such oral vaccine and the potential effectiveness,
safety, immunogenicity and other advantages of the vaccine against
current and future coronavirus strains or for the broader vaccines
market and the potential of ORMD-0801 to be the first commercial
oral insulin capsule for the treatment of diabetes. 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:
Zach
Herschfus
+1-844-9-ORAMED
zach@oramed.com
Logo:
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SOURCE Oramed Pharmaceuticals Inc.