Lexaria
Issues Successful
Results
from First 2021 Study,
HYPER-A21-1
-
Up to
2,178%
more
CBD
delivered into
bloodstream*
-
Up
to
1,737%
more CBD delivered
into brain
tissue*
Kelowna,
British Columbia,
May
6,
2021 –
InvestorsHub NewsWire - Lexaria Bioscience Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (CSE: LXX) (the "Company"
or
"Lexaria"), a global innovator in
drug delivery platforms, is pleased to announce
successful
outcomes in its first sets of data from its
2021 applied research and development
(R&D) study programs.
Study HYPER-A21-1 included three new "DehydraTECH
2.0" formulation variations
designed
to enable
cannabidiol
("CBD") delivery
performance
enhancements and pharmacokinetic
optimization.
All three
new DehydraTECH
2.0 formulations delivered
improved
performance
when
compared to both Lexaria's original DehydraTECH 1.0 and 2.0 concentration-matched
formulations,
as well as
to a medium chain
triglyceride ("MCT") oil based control formulation
representative
of standard industry
practices Summary data is shown
below:
Formulation
|
AUClast
(1)
(hr·kg·ng
/mL/mg)
|
%
Improvement over MCT
Formulation
(p
value)
|
%
Improvement over original
DehydraTECH
1.0
(p
value)
|
%
Improvement over original DehydraTECH 2.0
(p
value)
|
MCT
Control (2)
|
13.17
± 6.78
|
--
|
--
|
--
|
Original
(2)
DehydraTECH 1.0
|
64.6
±
23.7
|
390%
(p=0.00002)
|
--
|
--
|
Original
(3)
DehydraTECH
2.0
|
134.7
±
63.7
|
923%
(p=0.00009)
|
108%
(p=0.0036)
|
--
|
**NEW**
DehydraTECH 2.0
Formulation 1 (4)
|
153.9 ± 62.8
|
1,068%
(p=0.00003)
|
138%
(p=0.0006)
|
14%
(p=0.253)
|
**NEW**
DehydraTECH 2.0 Formulation
2
(4)
|
216.0 ± 94.9
|
1,540%
(p=0.00004)
|
234%
(p=0.0003)
|
60%
(p=0.018)
|
**NEW**
DehydraTECH 2.0
Formulation 3 (4)
|
300.1
±
126.6
|
2,178%
(p=0.00007)
|
364%
(p=0.0002)
|
123%
(p=0.002)
|
(1)
AUC: Area Under
the Curve,
or total CBD delivery into the
rodent bloodstream
(2)
60-minute
study
duration
(3)
60-minute study
duration evaluated in 2019
(4)
120-minute study
duration evaluated in 2021
"Not only did the three latest DehydraTECH 2.0 formulations
deliver
between 1,068%
and 2,178%
more CBD
during the study period than the standard MCT control formulation, they also were
up to 123%
more
effective than the original DehydraTECH
2.0 formulation,"
said
Chris
Bunka, CEO
of
Lexaria. "Said another way,
for every 1 mg of
CBD delivered by the industry standard
MCT
control formulation, these
latest
DehydraTECH 2.0
formulations delivered 10 to 21
mg
of
CBD."
The study demonstrated
that each of the new DehydraTECH 2.0 formulations
delivered
very
high levels of CBD absorption
into brain tissues,
dwarfing
the levels
achieved
with
the
MCT oil-based
control formulation.
The three new DehydraTECH 2.0 formulations delivered between
907%-1,737%
more CBD into brain tissue
than the MCT oil
based control formulation,
similar
to the
up to
1,937% increase over the MCT oil
based control
formulation announced previously for Lexaria's original DehydraTECH
2.0 formulation.
In each arm of the study,
ten male
Sprague-Dawley rats
were dosed orally
at a level
of 25 mg/Kg CBD, and over the next 120
minutes multiple measurements
were made of delivery into the bloodstream
and tissues comparing the
DehydraTECH formulations to
certain
controls.
These
study findings
add
significantly to Lexaria's
body
of evidence demonstrating the
ability of its DehydraTECH
technology
to
be
engineered
to
enhance the
delivery of lipophilic
active ingredients
such as
CBD
across a range of
uptake
levels,
whereby higher
delivery
level
targets may be
most
applicable to pharmaceutical
dosage forms and lower
delivery
level
targets
more suited
to
consumer packaged
goods.
Additional DehydraTECH 2.0
formulations are being evaluated in Lexaria
study
HYPER-A21-2 presently underway,
and results are
expected in late May
or early
June,
2021. Thereafter,
Lexaria
is planning additional work that will evaluate impacts upon real-time blood pressure
in
animals using select
formulations pursuant to these
studies. Lexaria will provide more details on
this
upcoming blood pressure testing in animals as they become
available. As well, advanced DehydraTECH 2.0
formulations are already being used by Lexaria in
ongoing human studies
and
will be monetized for
commercial
use when
applicable.
* Compared
with control
formula
utilizing
medium chain triglycerides
(coconut
oil) representative
of standard
industry practices
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
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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