Lexaria's
DehydraTECH
Significantly Enhances Delivery of Colchicine in
Study
VIRAL-A20-3
Possible
Benefits for Treating
SARS-CoV-2/COVID-19
and mRNA
Vaccine Side Effects
Kelowna,
British Columbia, Canada -- July 21, 2021 -- InvestorsHub NewsWire
-- Lexaria Bioscience
Corp. (Nasdaq:
LEXX) (Nasdaq:
LEXXW) (the "Company" or
"Lexaria"), a global innovator in drug
delivery platforms is pleased to
announce
that
its
tolerability and
pharmacokinetic study VIRAL-A20-3 has been completed
with positive
results.
This study demonstrated that
DehydraTECHTM
enabled
colchicine, the latest of several drugs Lexaria has successfully
tested with known SARS-CoV-2
antiviral properties, benefited from our proprietary formulation
and processing, resulting in increased
delivery:
Drug
|
Cmax*
% Improvement
(ng/mL)
|
Control
(ng/mL)
|
AUClast**
% Improvement
(hr·ng/mL)
|
Control
(hr·ng/mL)
|
Colchicine
|
31.97
91%
(p=0.0005)
|
16.73
|
104.43
167%
(p=0.0028)
|
38.97
|
Colchicine is an approved
therapeutic with anti-inflammatory effects that is principally used
to treat gout and conditions such as cardiac inflammation
(i.e.,
pericarditis), and also has potent effects in
mitigating the cytokine storm associated with
SARS-CoV-2/COVID-19. Colchicine is
occasionally
recommended and
used to treat emergent pericarditis in children in cases
where this
form of cardiac inflammation develops following
administration of mRNA
COVID-19 vaccines.
Similar to
other antiviral
agents that Lexaria has
processed
with
DehydraTECH (e.g., darunavir, efavirenz,
remdesivir's nucleoside analogue GS-441524 and
ebastine), oral colchicine in its
available forms today exhibits diminished bioavailability in
humans, which Lexaria believes it can improve upon for better
safety and efficacy outcomes. Currently available oral
colchicine demonstrates bioavailability of
about 45%.
Colchicine is
also
known to have
a
narrow therapeutic index, meaning the distinction
between toxic and non-toxic doses is marginal and there could be
significant benefits in allowing its dosing to be reduced while
maintaining therapeutic delivery levels. Lexaria hopes to improve the
bioavailability of colchicine to a sufficient level
which
could potentially allow for lower
overall dosing requirements.
Study VIRAL-A20-3 was
performed using Sprague-Dawley rats, with twenty rats dosed via
oral gavage using either DehydraTECH or control
colchicine formulations (i.e,. 10 rats per test
article). The
study evaluated peak
concentration ("Maximum Concentration" or "Cmax"*)
and total
drug delivery into the rodent bloodstream ("Area
Under the Curve"
or "AUClast**").
The study was
conducted by an independent, premier animal testing laboratory
located in the United States.
The study also examined
absorption with two other antiviral drugs previously untested by
Lexaria. The
bloodstream
delivery findings were unremarkable with these two
drugs,
which Lexaria believes was correlated to
analytical
methodology limitations related to discerning blood levels for the
two drugs in question. Further work
would
be required
should Lexaria decide to pursue additional testing with these two
drugs, however, Lexaria will
likely
focus on
DehydraTECH-processed colchicine and other antiviral drugs
it has
tested given the superior results already
demonstrated.
Lexaria will summarize
and provide
guidance on the 2021 antiviral program to
date and
next steps it is planning in an imminent press
release. Chris Bunka, CEO, is
responsible for the accuracy of this press release. 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