Lexaria
Summarizes
Successful Antiviral Drug Studies
and Ongoing
Strategy
All
objectives evaluating
DehydraTECHTM
drug
delivery platform successfully
achieved
Kelowna,
British Columbia, Canada -- July 22, 2021 -- InvestorsHub NewsWire
-- Lexaria Bioscience
Corp. (Nasdaq:
LEXX) (Nasdaq:
LEXXW) (the "Company" or
"Lexaria"), a global innovator in drug
delivery platforms is pleased to
review its
successful
2021 antiviral
drug program to date and summarize expected next
steps.
Lexaria's objectives
in its 2021 antiviral drug
examination program thus far have been to
determine
whether:
-
DehydraTECH
processing of compounds from leading
classes of
antiviral
drugs
for
SARS-CoV-2/COVID-19, HIV/AIDS and other infectious
diseases could exhibit evidence of
superior oral absorption
relative to
controls,
-
DehydraTECH
processing of those compounds would preserve expected viral
inhibitory performance upon efficacy testing
in infected
mammalian cells, and
-
DehydraTECH
does
not alter
nor
degrade the drug molecules
chemically
as to create new
molecular entities that could be challenging to guide
through the regulatory approval process.
All three of
these
objectives have been met.
Lexaria has successfully
tested and published summary results on five compounds from
three antiviral drug classes, and in each of these drug
classes has evidenced significant gains with up to
a three-fold increase in oral drug delivery into the bloodstream
("Area Under the
Curve" or "AUC") upon animal testing
when processed
with DehydraTECH:
Protease Inhibitors ("PI"): Darunavir and
Ebastine (AKA an antihistamine
and 3CL
or
SARS-CoV-2 main protease "MPro"
inhibitor)
Reverse Transcriptase Inhibitors ("RTI"):
Efavirenz
(AKA a
non-nucleoside
RTI
or
"NNRTI")
and Remdesivir (AKA a
nucleotide
RTI
or
"NtRTI";
quantified in
its nucleoside analogue metabolite
form
GS-441524)
Tubulin Polymerization and Microtubule Inhibitor
("TPMI"):
Colchicine (AKA
an
anti-inflammatory)
Lexaria believes that the
absorption gains it has demonstrated with the above
compounds from their respective antiviral
drug classes could have significant commercial
potential given
the fact that many antiviral drugs exhibit diminished oral
bioavailability in their available forms today due to poor
intestinal uptake and/or significant liver
biotransformation. The DehydraTECH delivery system
is designed to overcome this bioavailability
issue.
For example,
drugs like
colchicine in its currently available oral form demonstrate
bioavailability of
about 45%, and are also known to
have a
narrow therapeutic index, meaning that the
distinction between toxic and non-toxic doses is
marginal.
There could be significant
benefits in allowing its dosing to be reduced while maintaining
therapeutic delivery levels. DehydraTECH formulations of
antiviral compounds such as colchicine
have the
potential to lead to significantly
improved bioavailability while
allowing for lower overall dosing requirements and improved safety
and tolerability. The majority of
drugs that
are currently delivered
via
injection
could also experience lower costs of
administration and larger market potential if delivery
characteristics were enhanced sufficiently to
allow for oral dosing.
The next steps in Lexaria's
DehydraTECH antiviral drug testing program are expected to
include,
but not be limited to,
larger
in
vivo efficacy
evaluations in animals infected with
SARS-CoV-2, HIV or other infectious
disease-causing
viruses,
which Lexaria is
planning,
subject to
further
investigation
to select lead
compounds based on our work to-date for this
effort. The Company will
release further plans and
results
related to
these
upcoming
studies as they
become available.
Lexaria is working diligently
on a comprehensive, multi-pronged program that is intended to
demonstrate pivotal
proof-of-concept safety, efficacy and
formulation/scalability
feasibility data to prospective
pharmaceutical industry partners with a view to creating opportunities for
expanded,
collaborative
product development. The Company is interested in
pursuing strategic collaboration opportunities with established
pharmaceutical industry partners who may be interested in
incorporating DehydraTECH technology with antiviral drugs including
and/or similar to
those that are
currently being investigated. Lexaria would like to
evidence that DehydraTECH
works to
enhance the oral delivery characteristics
of the drugs mentioned above
and potentially
others which are used to fight many
virus triggered diseases, including
but not limited
to shingles, influenza and viral forms of
gastroenteritis, hepatitis, meningitis, and pneumonia.
Antiviral
Drug Background and
DehydraTECH
Formulation Strategy
The first antiviral drug was
approved for use in the USA in 1963, and over 90 additional
antiviral drugs
have been approved since, with thousands of
other antiviral inhibitors having been proposed.
Eleven of the
approved drugs are used to treat more than one infectious disease,
illustrating that some of these drugs are effectively used for
multiple applications.
Antiviral drugs treat those
who have been infected and try to preserve life; whereas antiviral
vaccines are administered to those who are not infected
in an
effort to prevent or lessen the severity
of subsequent
infection.
Of note, "antiviral drugs from the
same drug group share similar mechanisms of drug action to inhibit
viral reproduction
during the viral life cycle."
This phenomenon is a crucial component to Lexaria's strategy of
evidencing
that DehydraTECH improves the delivery characteristics of
many drugs from the classes Lexaria has
investigated,
potentially assisting in their efficacy for both their original
approved use, as well as for use treating additional health
indications if/when that delivery performance has been
enhanced.
For
example,
there are
six main classes of antiviral drugs
used to treat
HIV, including drugs from the PI and RTI classes, above.
There are
37.7 million people
currently known to be infected with
HIV and 36.3 million
people
have died from HIV/AIDS since the
beginning of the epidemic, roughly equal to the entire population
of Canada. There are over
200 drugs approved by
the
FDA to
treat HIV/AIDS. Because of the massive regulatory and scientific
response to the onset of HIV, this disease is thankfully
killing fewer
people now than in the past, although significant demand
remains for safe and effective HIV/AIDS therapies that can be used
on a chronic treatment basis to preserve life.
Influenza is caused by
viruses even though
vaccines have
been widely available for years and remain the #1 recommended
method to prevent infection. Despite that, between 290,000 and
650,000 people
die
every year
from seasonal influenza. The 1918-19 influenza
epidemic is thought to have killed up to 50 million people, and the
1958 and 1968 influenza epidemics are thought to have killed
between
1 and 4 million people each. There are
only 4 drugs approved by
the
FDA to
treat influenza; three of them belong to the
Neuraminidase Inhibitors class and must be administered by
injection, and one belongs to the PA endonucleases inhibitor class
and is taken as an oral tablet.
Over 189 million people have
been infected by SARS-CoV-2 in the current global epidemic, and
over 4 million
have died to date. It is not known
today if
or when
infections and deaths will stop. Many drugs are being
investigated for use in treatment of SARS-CoV-2, including but not
limited to compounds from each of the PI,
RTI, and TPMI drug classes.
Only remdesivir
has received emergency use authorization from the FDA for treatment
of SARS-CoV-2.
Regardless of the efficacy and
availability of vaccines to prevent many viral infections
including
influenza vaccines that have been widely
available since 1945, thousands of people die
every year because they are infected with viruses while
unvaccinated, or
live
in large areas of
the world where vaccines are not available.
It is currently
estimated that
over 99% of the over
200,000
deaths in
the US since January 1, 2021
from SARS-CoV-2
have occurred in unvaccinated victims, demonstrating the
vital current need for successful treatment
options for those who are
unvaccinated.
Based on all these facts, the
need and demand for effective antiviral drugs via oral delivery
that are available to all, has never been more profound than today.
Lexaria has progressed significantly
in evidencing that its DehydraTECH delivery
technology can sufficiently enhance the usable fraction of known
antiviral drugs that reach the bloodstream so that they
can safely
and more
effectively do what they are designed to accomplish.
Lexaria
continues to
evaluate the data generated from its 2021
antiviral drug program and will make an announcement
regarding next steps as soon as
possible.
The Company is not making any
express or implied claims that its products have the ability to
eliminate, cure
or contain the COVID-19 pandemic (or SARS-CoV-2 or novel
Coronavirus) or any other virally induced diseases at this
time.
About
Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s
proprietary drug delivery technology, DehydraTECH™, improves the
way active pharmaceutical ingredients (APIs) enter the bloodstream
by promoting healthier oral ingestion methods and increasing the
effectiveness of fat-soluble active molecules, thereby lowering
overall dosing. The Company's technology can be applied to many
different ingestible product formats, including foods, beverages,
oral suspensions, tablets, and capsules. DehydraTECH has repeatedly
demonstrated since 2016 with cannabinoids and nicotine the ability
to increase bio-absorption by up to 5-10x, reduce time of onset from 1
- 2 hours to minutes, and mask unwanted tastes; and is planned to
be further evaluated for orally administered bioactive molecules,
including anti-virals, cannabinoids, vitamins, non-steroidal
anti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has
licensed DehydraTECH to multiple companies including a
world-leading tobacco producer for the development of smokeless,
oral-based nicotine products and for use in industries that produce
cannabinoid beverages, edibles, and oral products. Lexaria operates
a licensed in-house research laboratory and holds a robust
intellectual property portfolio with 20 patents granted and
approximately 60 patents pending worldwide. For more information,
please visit
www.lexariabioscience.com.
CAUTION
REGARDING FORWARD-LOOKING
STATEMENTS
This press release includes
forward-looking statements. Statements as such term is defined
under applicable securities laws. These statements may be
identified by words such as "anticipate," "if," "believe," "plan,"
"estimate," "expect," "intend," "may," "could," "should," "will,"
and other similar expressions. Such forward-looking statements in
this press release include, but are not limited to, statements by
the company relating the Company's ability to carry out research
initiatives, receive regulatory approvals or grants or experience
positive effects or results from any research or study. Such
forward-looking statements are estimates reflecting the Company's
best judgment based upon current information and involve
a number of
risks and
uncertainties, and there can be no assurance that the Company will
actually achieve the plans, intentions, or expectations disclosed
in these forward-looking statements. As such, you should not
place undue reliance on these forward-looking
statements. Factors which could cause
actual results to differ materially from those estimated by the
Company include, but are not limited to, government regulation and
regulatory approvals, managing and maintaining growth, the effect
of adverse publicity, litigation, competition, scientific
discovery, the patent application and approval process, potential
adverse effects arising from the testing or use of products
utilizing the DehydraTECH technology, the Company's ability to
maintain existing collaborations and realize the benefits
thereof, delays or cancellations of
planned R&D that could occur related to pandemics or for other
reasons, and other factors which may be
identified from time to time in the Company's public announcements
and periodic filings with the US Securities and Exchange Commission
on EDGAR. There is no assurance that any of Lexaria's postulated
uses, benefits, or advantages for the patented and patent-pending
technology will in fact be realized in any manner or in any part.
No statement herein has been evaluated by the Food and Drug
Administration (FDA). Lexaria-associated products are not
intended to diagnose, treat, cure or prevent any
disease. Any forward-looking statements
contained in this release speak only as of the date hereof, and the
Company expressly disclaims any obligation to update any
forward-looking statements contained herein, whether
as a result
of any new
information, future events, changed circumstances or otherwise,
except as otherwise required by law.
INVESTOR
CONTACT:
ir@lexariabioscience.com
Phone: 250-765-6424,
ext
202