Lexaria
to
Evaluate
DehydraTECHTM
in
Multiple
New
Markets
-
Undertaking
new
2021
R&D programs
in additional
drug markets
with combined market potential
of
$87
Billion.
Kelowna,
British Columbia,
Canada -- April
6,
2021 -- InvestorsHub NewsWire – Lexaria Bioscience
Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (CSE: LXX) (the "Company" or "Lexaria"), a global innovator in
drug delivery platforms, will begin
important
new
applied
research and
development (R&D) study programs planned
in
2021.
Lexaria's new study programs will
target four drug markets including
NSAIDs,
nicotine replacement therapies, tetrahydrocannabinol
and erectile dysfunction.
Each of the
studies will evaluate the rate of absorption
and
speed
(pharmacokinetics
or
"PK" assessments)
with which
various
new enhanced DehydraTECHTM
experimental formulations
–
"DehydraTECH 2.0" – deliver the drugs being
studied into the bloodstream
and, in some cases the brain, after oral dosing. Evidencing
improvements in delivery
efficiencies or reductions in time
required to deliver drugs into bloodstream and brain is intended to support further study and commercial
exploitation through prospective pharmaceutical
industry
strategic partnering.
"Our 2021 study program
–
already
the largest in
our company's history – is growing," commented
Chris Bunka,
CEO of
Lexaria. "All of our studies are
designed
to generate must-have data allowing us to have more meaningful
business
discussions with various industry leaders and as such,
can
shorten the time required for
positive commercial developments."
Ibuprofen
(such
as Advil) and
Naproxen
(such as
Aleve):
NSAID-A21-1.
Test articles are
planned
to be
manufactured in April
and animal dosing is expected
in
July. The global NSAID market was
US$15.6 Billion in 2019,and is
expected to grow
to $24.4
Billion
in 2027.
Although
NSAIDs are
in widespread use they can cause
serious side effects such as gastrointestinal
toxicity, irreversible kidney damage,
and
16,500 deaths
per year. Lexaria will
investigate
whether
DehydraTECH-processed NSAIDs might achieve higher
bioavailability
and brain
uptake than conventional
formulations
and, in turn,
be able to be
used at lower dosage levels, in order to
lower
unwanted side
effects. Lexaria has selected
ibuprofen and
naproxen for this exercise, as two
of the most common NSAIDs in use
today, predominantly
for
management
of chronic inflammation
and pain
respectively. DehydraTECH for
oral
NSAID
delivery
is
covered by
existing
granted Lexaria patents in the USA
and
internationally as well as additional patent
applications pending
globally.
THC:
THC-A21-1.
Test articles
are
planned
to be
manufactured in July and animal dosing is expected in
August/September. Lexaria has a successful
track
record through strategic partners and licensees who use DehydraTECH technology
and
have demonstrated improved delivery
and performance
of tetrahydrocannabinol
("THC") in both subjective
human studies and marketed
consumer
packaged goods
product
offerings. Furthermore,
Lexaria
has repeatedly
demonstrated
that
DehydraTECH-processed
cannabidiol (CBD) (another common
cannabinoid)
has superior
delivery
characteristics into the bloodstream and brain
compared to
generic CBD, and expects to generate
similar
results with THC. Successful results from
this
study will
support efforts to
commercialize
DehydraTECH
within the registered THC industry. The global
licensed
dispensary market for
cannabis
is projected
to be $40.6 Billion in 2024. DehydraTECH for
oral THC
delivery is covered by
existing
granted Lexaria patents in the USA and internationally
as well as additional patent
applications pending
globally. Lexaria divested
certain of its
THC-related business assets as it
prepared for its uplisting to
the Nasdaq
marketplace, however, it retained all rights to
use its
DehydraTECH technology with
THC
related
to pharmaceutical
purposes or registered drugs within its wholly
owned subsidiary
Lexaria
Pharmaceutical Corp.
Oral
Nicotine:
NIC-C21-1
Test articles
have been
manufactured and dosing is expected
in
September/October. The global market for
smokeless
tobacco and nicotine replacement
therapy (NRT) pharmaceutical
products
was $15.5 Billion in 2018. Lexaria has repeatedly demonstrated that
DehydraTECH-processed
nicotine has
superior delivery characteristics compared to
generic nicotine when
dosed
orally
and swallowed for intestinal delivery
to the bloodstream.
Lexaria's
limited
subjective
human testing
utilizing
DehydraTECH-processed
nicotine
formulations
have
demonstrated
nicotine absorption
and onset of nicotine effectiveness
in as little as
1.5-4
minutes after an oral dose
compared to average 8-10
minutes
with
comparable pouches.
The upcoming
PK test will
measure the delivery of
nicotine directly into
oral mucosal
tissues to evaluate
potential
superior
delivery characteristics
without the need to swallow. Both cigarette and
e-cigarette sales are trending lower due to well-publicized
issues regarding
health;
whereas
oral nicotine products were the first ever to receive an
FDA reduced
risk notice.
Modern
oral
nicotine
products
contain no tobacco, unlike older consumer products which contain moist tobacco. DehydraTECH for oral nicotine
is covered
by existing
granted Lexaria patents in the USA and internationally
as well as additional patent
applications pending
globally.
Sildenafil
(such
as Viagra):
PDE5-A21-1
Test article
manufacturing is planned
for
October
and
animal
dosing is expected
in
November/December. The erectile
dysfunction market was worth $4.8 Billion in 2018
and
expected to reach
$7.1
billion in 2024. Phosphodiesterase-5
inhibitor (PDE5)
drugs
work
using
a process of
vasodilation and most
are considered to
be slow acting,
requiring 1-2 hours to reach peak levels in the
bloodstream for maximum
effectiveness. Lexaria has
repeatedly
evidenced a greatly reduced delivery time of
another drug that encourages
vasodilation
–
DehydraTECH CBD – and theorizes whether
DehydraTECH might
likewise
deliver PDE5
drugs more
quickly and effectively. Some of the most
popular
existing erectile
dysfunction drugs have seen
their primary patents expire.
DehydraTECH for PDE5
drugs is
patent pending.
All scheduling is
subject to
change, postponement
or even
cancellation, but as of the date of this
press
release are reasonable expectations.
All studies
referenced
within this
press
release
are fully
funded from existing Company resources and are being performed
by
third-party
laboratories to ensure study objectivity.
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 18 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.
The CSE
has not
reviewed and
does
not accept
responsibility
for the adequacy or accuracy
of this
release.
INVESTOR
CONTACT:
ir@lexariabioscience.com
Phone:
866-221-3341