Lexaria's
Newest
DehydraTECHTM
2.0
Formulation
Tested
in Study
HYPER-A21-2 Demonstrates
Its
Strongest
CBD
Absorption
Results
Ever
-
New
formulation delivers up to
2,708%
more
CBD
into
bloodstream*
-
Human
clinical
hypertension
study
HYPER-H21-1
also
progressing
Kelowna,
British Columbia,
May
20,
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
test
results of
two new "DehydraTECH™
2.0" cannabidiol
("CBD") formulations
in its
second
2021
applied research and
development study
program, HYPER-A21-2.
"One of our
latest
DehydraTECH 2.0 formulations
gave us the
strongest absorption enhancement
results
we've ever
recorded, at 2,708% more CBD into the bloodstream
during
the
study
period than the representative industry
standard
MCT
control formulation. It was also 174% more effective than the original DehydraTECH
2.0 formulation
from
2019," said Chris Bunka, CEO
of
Lexaria. "This is a 27-fold improvement
in
CBD
delivery compared to
the
control formulation."
Study HYPER-A21-2 included three additional new DehydraTECH
2.0
formulation
variations designed to enhance CBD delivery performance and pharmacokinetic
optimization.
Two of the
three new DehydraTECH 2.0
formulations
delivered improved performance
when
compared to both Lexaria's original DehydraTECH 1.0 and 2019 DehydraTECH
2.0
concentration-matched
formulations,
as
well as to
a
medium chain
triglyceride ("MCT") oil based control formulation representative of
standard industry
practices. The final formulation provided useful
data but did not deliver
enhanced performance
compared
to the original DehydraTECH
2.0. 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
5
(4)
|
187 ± 95
|
1,322%
(p=0.0001)
|
190%
(p=0.001)
|
39%
(p=0.08)
|
**NEW**
DehydraTECH 2.0
Formulation 6 (4)
|
370 ± 172
|
2,708%
(p=0.00005)
|
472%
(p=0.0001)
|
174%
(p=0.0008)
|
(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
Lexaria
continues
to build a robust
body
of evidence demonstrating that
its patented
DehydraTECH
technology
can significantly
enhance
the
delivery of lipophilic
active ingredients
such as
CBD
across a range of
uptake
levels,
with ultimate
applications
to
wide ranging areas
including
consumer
packaged goods as well as drugs with potential
for disease treatment
applications.
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 taken to assess delivery into the bloodstream
and tissues comparing the
DehydraTECH formulations to
certain
controls. There were a total of
120
animals for the new DehydraTECH 2.0
formulations evaluated in studies HYPER-A21-1 and HYPER-A21-2. Both studies HYPER-A21-1 and HYPER-A21-2 were conducted by
an independent, premier animal testing
laboratory located in the United
States.
Lexaria also confirms
that its
HYPER-H21-1
human
clinical
hypertension
study
is
currently
underway
and dosing is nearly
complete,
utilizing
a
formulation
most closely resembling
the
original 2019
DehydraTECH 2.0.
Along with a more than
3-fold increase in dose
quantity,
these
formulation
improvements are
expected to
be more effective
than
the original DehydraTECH
1.0
formulation
used in Lexaria's
foundational
2018 human clinical study
that
nonetheless
evidenced significant blood pressure reduction,
as
published
and available
at
PubMed.
Lexaria
thus
expects
improved
pharmacokinetic
performance
in
its
current
human clinical
study
to
translate
into
further improved
pharmacodynamic performance.
Lexaria will provide
details
on the outcomes of study HYPER-H21-1 when they become
available.
* 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
19
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