RCS - Lexaria Bioscience - Lexaria to Evaluate Impact of DehydraTECH

Novo Nordisk A/SAnnouncement

21/09/2023 15:15

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230921:nRSU1527Na&default-theme=true

RNS Number : 1527N  Lexaria Bioscience Corp.  21 September 2023

Lexaria to Evaluate Impact of DehydraTECH on Oral Performance of GLP-1 drugs
used in products such as Ozempic, Wegovy and Rybelsus, Alone or Together with
DehydraTECH-CBD

DehydraTECH-powered GLP-1 drugs will be evaluated for potential improvements
such as:

·      Reduced side effects;

·      Enhanced weight loss;

·      Improved health outcomes for diabetes and other conditions;

·      Improved oral bioavailability;

·      Reduced cost.

KELOWNA, BC / ACCESSWIRE / September 21, 2023 / Lexaria Bioscience Corp.
(Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator
in drug delivery platforms announces its intention to launch new human and
animal studies to examine DehydraTECH™-processed glucagon-like peptide-1
("GLP-1") drugs such as, but not limited to, semaglutide sold under Novo
Nordisk's brand names Ozempic®, Wegovy® and Rybelsus®, for purposes of
improved bioavailability, cost-effectiveness, tolerability, weight loss
potential, management of diabetes and other health conditions.

Through these studies, Lexaria hopes to achieve superior pharmacokinetic
("PK") performance using DehydraTECH-powered GLP-1 drugs which could enable
drug delivery via oral capsule at lower costs than current injectables, with
reduced side effects and enhanced health benefits.

This is a significant expansion of Lexaria's ongoing and planned diabetes
study program to examine its patented DehydraTECH-CBD for diabetes control in
humans. The Company now intends to evaluate this alongside and together with
DehydraTECH-processed GLP-1 agents. Program design has already commenced, and
initial study work will begin as soon as possible.

Lexaria has demonstrated in many previous R&D programs, including five
human clinical studies, that DehydraTECH can greatly improve the PK
performance of many orally administered drugs into the bloodstream, such as
certain antiviral drugs, estradiol, PDE-5 Inhibitors, cannabinoids and more.
Like many of these agents, GLP-1 drugs also exhibit low oral bioavailability
without the use of absorption enhancement technology, such as Lexaria's
DehydraTECH. Lexaria has also previously shown in animal studies that its
patented DehydraTECH-CBD lowered body weight over a sustained dosing period by
7%, and also lowered blood sugar and triglyceride levels.

The Company has also demonstrated that specific customized DehydraTECH oral
capsule formulations can achieve remarkable improvements in PK performance.
For example, the particular DehydraTECH-CBD formulation that was used in its
recently completed DIAB-A22-1 (https://pr.report/w9ycLFVP) diabetes study
demonstrated almost a 3-fold improvement in drug delivery into blood than the
differentiated DehydraTECH-CBD formulation that was used in Lexaria's
HYPER-H21-4 hypertension study that, itself, demonstrated significantly better
PK (https://pr.report/Inmqy9Qf) performance and effectiveness than
pharmaceutical-grade CBD industry comparators like Epidiolex
(https://pr.report/dUSF1kDP) ®.

About GLP-1 Drugs.

GLP-1 drugs have recently been approved by the Food and Drug Administration
("FDA") for type two diabetes and weight loss management. Weight loss of
between 10 pounds to 33 pounds
(https://www.cnbc.com/2023/05/22/pfizer-weight-loss-drug-compares-to-ozempic-by-novo-nordisk.html?&qsearchterm=Ozempic%20and%20Wegovy)
, or more, has been widely reported. One 68-week study of 667 people reported
an average loss of 15% of body weight (https://pr.report/RWp1sThN) .

Widely reported anecdotal commentary is also suggesting that some patients are
experiencing reduced cravings for alcohol, nicotine and opioids
(https://www.cnbc.com/2023/09/10/ozempic-wegovy-drinking-smoking-what-we-know.html?&qsearchterm=Ozempic%20and%20Wegovy)
while taking GLP-1 drugs. Other trials are examining their effects on heart
disease and even dementia
(https://www.cnbc.com/2023/09/07/weight-loss-drugs-wegovy-ozempic-tested-to-treat-addiction-dementia.html?&qsearchterm=Ozempic%20and%20Wegovy)
in part because of evidence that GLP-1 drugs may reduce the build-up of the
proteins amyloid and tau in the brain, thought to be partly responsible for
Alzheimer's disease.

Side effects of the GLP-1 drugs (https://pr.report/9s0mQP7O) vary but can
include nausea, vomiting, diarrhea and more. A small number of GLP-1 drugs
have already been approved in oral format but some studies have reported worse
side effects with the oral form (https://pr.report/jr2qf48m) . The drugs are
also being investigated for their relationship to bone density, muscle loss
and more. Because of potential serious side effects, it may be beneficial to
treat patients with lower oral doses of the drugs, something that Lexaria's
DehydraTECH technology may enable if it can improve the PK performance of
GLP-1 drugs through oral capsules.

Although the GLP-1 drugs are effective at controlling diabetes and promoting
weight loss, they are expensive, and the benefits often reverse if the patient
stops taking the drug. Typical non-insured costs of US$900/month
(https://pr.report/kdhFHc9p) or more are common. If DehydraTECH improves the
PK performance of oral GLP-1 drugs it could potentially result in cost savings
for the patient through lower doses.

Because GLP-1 drugs have experienced FDA approvals as recently as 2021 and
2022, and because the health benefits of this drug class are still being
discovered and understood, the potential market size is still unknown.
Published reports are widely estimating $100 billion in sales per year, by
2030. At least one analyst from Guggenheim Partners published a note on
September 12 in which he explained how "the total addressable market for these
so-called incretin drugs could balloon to $150 billion to $200 billion
(https://pr.report/37aT5wzg) ."

About Lexaria's Diabetes Study Program.

Lexaria began its DehydraTECH diabetes-related formal studies in 2022. On
March 2, 2023 (https://pr.report/QGjWLAvZ) and June 16, 2023
(https://pr.report/Hq9Dc3Fo) Lexaria announced that in pre-clinical diabetes
study DIAB-A22-1 (https://pr.report/wNBheF27) in obese diabetic-conditioned
animals, DehydraTECH-CBD achieved each of the following:

·      Lowered blood glucose levels by 19.9% (p<0.05)

·      Lowered overall body weight by 7% sustained over 8 weeks

·      Increased locomotor activity (p<0.05)

·      Lowered triglyceride levels by more than 25% (p<0.007)

·      Lowered blood urea nitrogen levels by 27.9% (p<0.001)

On August 2, 2023 Lexaria announced its intention (https://pr.report/gTy0vu7V)
to study weight loss and diabetes control in a human population using
DehydraTECH-CBD.

Lexaria's goals within its diabetes study program have significantly expanded
and now include the concept of applying DehydraTECH technology, individually,
to each of CBD and GLP-1 drug(s), but also to potentially utilize a
combination of drugs that includes both a GLP-1 component and DehydraTECH-CBD,
together. At this time, no other company in the world is utilizing DehdyraTECH
technology relative to GLP-1 drugs.

DehydraTECH-CBD's ability to reduce blood sugar levels in animals is extremely
encouraging and warrants additional investigation. According to the Center for
Disease Control, managing your blood sugar levels
(https://www.cdc.gov/diabetes/managing/manage-blood-sugar.html#:~:text=It's%20important%20to%20keep%20your,improve%20your%20energy%20and%20mood.)
is important to avoid diabetes-related conditions such as vision loss, heart
disease, and kidney disease. Limited research, mostly in animal studies,
indicates that without DehydraTECH's noteworthy performance enhancements,
generic CBD might be ineffective in controlling blood sugars
(https://diabetes.org/healthy-living/medication-treatments/cbd-diabetes#:~:text=There's%20a%20lot%20of%20hype,people%20with%20type%202%20diabetes.)
.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform
technology Lexaria has developed and is investigating for a variety of
beneficial molecules. DehydraTECH is designed to improve the way active
molecules enter the bloodstream upon oral ingestion. DehydraTECH has also
demonstrated enhanced delivery of certain active molecules into brain tissue,
which Lexaria believes to be of particular importance for centrally active
compounds. Lexaria has also developed DehydraTECH formulations for other
applications demonstrating superior bio-absorption when administered
intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™,
improves the way active pharmaceutical ingredients (APIs) enter the
bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly
demonstrated the ability to increase bio-absorption with cannabinoids,
antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an
ability to deliver some drugs more effectively across the blood brain barrier.
Lexaria operates a licensed in-house research laboratory and holds a robust
intellectual property portfolio with 36 patents granted and many patents
pending worldwide. For more information, please visit
www.lexariabioscience.com (https://pr.report/XNTHfPWU) .

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. The Company provides links to third-party websites only
as a courtesy to readers and disclaims any responsibility for the
thoroughness, accuracy or timeliness of information at third-party websites.
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 or links to third-party websites contained herein, whether as a
result of any new information, future events, changed circumstances or
otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
ir@lexariabioscience.com (mailto:ir@lexariabioscience.com)

Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRALBMTTMTATMFJ