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All objectives evaluating DehydraTECH drug delivery platform successfully achieved

KELOWNA, BC / July 22, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to review its successful 2021 antiviral drug program to date and summarize expected next steps.

Lexaria's objectives in its 2021 antiviral drug examination program thus far have been to determine whether:

  • DehydraTECH processing of compounds from leading classes of antiviral drugs for SARS-CoV-2/COVID-19, HIV/AIDS and other infectious diseases could exhibit evidence of superior oral absorption relative to controls,
  • DehydraTECH processing of those compounds would preserve expected viral inhibitory performance upon efficacy testing in infected mammalian cells, and
  • DehydraTECH does not alter nor degrade the drug molecules chemically as to create new molecular entities that could be challenging to guide through the regulatory approval process.

All three of these objectives have been met.

Lexaria has successfully tested and published summary results on five compounds from three antiviral drug classes, and in each of these drug classes has evidenced significant gains with up to a three-fold increase in oral drug delivery into the bloodstream ("Area Under the Curve" or "AUC") upon animal testing when processed with DehydraTECH:

Drug

Drug Class

AUC DehydraTECH Delivery Improvement (hr ng/mL)

Efavirenz

RTI

42% (p=0.028)

Darunavir

PI

54% (p=0.036)

Remdesivir

(GS-441524)

RTI

82% (p=0.12)

Colchicine

TPMI

167% (p=0.0028)

Ebastine

PI

204% (p=0.027)

Protease Inhibitors ("PI"): Darunavir and Ebastine (AKA an antihistamine and 3CL or SARS-CoV-2 main protease "MPro" inhibitor)

Reverse Transcriptase Inhibitors ("RTI"): Efavirenz (AKA a non-nucleoside RTI or "NNRTI") and Remdesivir (AKA a nucleotide RTI or "NtRTI"; quantified in its nucleoside analogue metabolite form GS-441524)

Tubulin Polymerization and Microtubule Inhibitor ("TPMI"): Colchicine (AKA an anti-inflammatory)

Lexaria believes that the absorption gains it has demonstrated with the above compounds from their respective antiviral drug classes could have significant commercial potential given the fact that many antiviral drugs exhibit diminished oral bioavailability in their available forms today due to poor intestinal uptake and/or significant liver biotransformation. The DehydraTECH delivery system is designed to overcome this bioavailability issue.

For example, drugs like colchicine in its currently available oral form demonstrate bioavailability of about 45%, and are also known to have a narrow therapeutic index, meaning that the distinction between toxic and non-toxic doses is marginal. There could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels. DehydraTECH formulations of antiviral compounds such as colchicine have the potential to lead to significantly improved bioavailability while allowing for lower overall dosing requirements and improved safety and tolerability. The majority of drugs that are currently delivered via injection could also experience lower costs of administration and larger market potential if delivery characteristics were enhanced sufficiently to allow for oral dosing.

The next steps in Lexaria's DehydraTECH antiviral drug testing program are expected to include, but not be limited to, larger in vivo efficacy evaluations in animals infected with SARS-CoV-2, HIV or other infectious disease-causing viruses, which Lexaria is planning, subject to further investigation to select lead compounds based on our work to-date for this effort. The Company will release further plans and results related to these upcoming studies as they become available.

Lexaria is working diligently on a comprehensive, multi-pronged program that is intended to demonstrate pivotal proof-of-concept safety, efficacy and formulation/scalability feasibility data to prospective pharmaceutical industry partners with a view to creating opportunities for expanded, collaborative product development. The Company is interested in pursuing strategic collaboration opportunities with established pharmaceutical industry partners who may be interested in incorporating DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated. Lexaria would like to evidence that DehydraTECH works to enhance the oral delivery characteristics of the drugs mentioned above and potentially others which are used to fight many virus triggered diseases, including but not limited to shingles, influenza and viral forms of gastroenteritis, hepatitis, meningitis, and pneumonia.

Antiviral Drug Background and DehydraTECH Formulation Strategy
The first antiviral drug was approved for use in the USA in 1963, and over 90 additional antiviral drugs have been approved since, with thousands of other antiviral inhibitors having been proposed. Eleven of the approved drugs are used to treat more than one infectious disease, illustrating that some of these drugs are effectively used for multiple applications.

Antiviral drugs treat those who have been infected and try to preserve life; whereas antiviral vaccines are administered to those who are not infected in an effort to prevent or lessen the severity of subsequent infection.

Of note, "antiviral drugs from the same drug group share similar mechanisms of drug action to inhibit viral reproduction during the viral life cycle." This phenomenon is a crucial component to Lexaria's strategy of evidencing that DehydraTECH improves the delivery characteristics of many drugs from the classes Lexaria has investigated, potentially assisting in their efficacy for both their original approved use, as well as for use treating additional health indications if/when that delivery performance has been enhanced.

For example, there are six main classes of antiviral drugs used to treat HIV, including drugs from the PI and RTI classes, above. There are 37.7 million people currently known to be infected with HIV and 36.3 million people have died from HIV/AIDS since the beginning of the epidemic, roughly equal to the entire population of Canada. There are over 200 drugs approved by the FDA to treat HIV/AIDS. Because of the massive regulatory and scientific response to the onset of HIV, this disease is thankfully killing fewer people now than in the past, although significant demand remains for safe and effective HIV/AIDS therapies that can be used on a chronic treatment basis to preserve life.

Influenza is caused by viruses even though vaccines have been widely available for years and remain the #1 recommended method to prevent infection. Despite that, between 290,000 and 650,000 people die every year from seasonal influenza. The 1918-19 influenza epidemic is thought to have killed up to 50 million people, and the 1958 and 1968 influenza epidemics are thought to have killed between 1 and 4 million people each. There are only 4 drugs approved by the FDA to treat influenza; three of them belong to the Neuraminidase Inhibitors class and must be administered by injection, and one belongs to the PA endonucleases inhibitor class and is taken as an oral tablet.

Over 189 million people have been infected by SARS-CoV-2 in the current global epidemic, and over 4 million have died to date. It is not known today if or when infections and deaths will stop. Many drugs are being investigated for use in treatment of SARS-CoV-2, including but not limited to compounds from each of the PI, RTI, and TPMI drug classes. Only remdesivir has received emergency use authorization from the FDA for treatment of SARS-CoV-2.

Regardless of the efficacy and availability of vaccines to prevent many viral infections including influenza vaccines that have been widely available since 1945, thousands of people die every year because they are infected with viruses while unvaccinated, or live in large areas of the world where vaccines are not available. It is currently estimated that over 99% of the over 200,000 deaths in the US since January 1, 2021 from SARS-CoV-2 have occurred in unvaccinated victims, demonstrating the vital current need for successful treatment options for those who are unvaccinated.

Based on all these facts, the need and demand for effective antiviral drugs via oral delivery that are available to all, has never been more profound than today. Lexaria has progressed significantly in evidencing that its DehydraTECH delivery technology can sufficiently enhance the usable fraction of known antiviral drugs that reach the bloodstream so that they can safely and more effectively do what they are designed to accomplish. Lexaria continues to evaluate the data generated from its 2021 antiviral drug program and will make an announcement regarding next steps as soon as possible.

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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/656564/Lexaria-Summarizes-Successful-Antiviral-Drug-Studies-and-Ongoing-Strategy

Possible Benefits for Treating SARS-CoV-2/COVID-19 and mRNA Vaccine Side Effects

KELOWNA, BC / July 21, 2021 / 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:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/656368/Lexarias-DehydraTECH-Significantly-Enhances-Delivery-of-Colchicine-in-Study-VIRAL-A20-3

VIRAL-MC21-1 Demonstrates Stability of DehydraTECH™-Enabled Antiviral Drugs

KELOWNA, BC / July 15, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce results from its antiviral drug molecular characterization study VIRAL-MC21-1 recently completed by Canada's premier federally funded research organization, the National Research Council ("NRC").

The NRC has successfully confirmed Lexaria's study objectives, demonstrating DehydraTECH™ processing and formulation technology does not create a covalently bonded new molecular entity ("NME") and that each drug tested remained stable and did not undergo change in chemical structure. The five drugs studied were remdesivir, ebastine, bepridil, rupintrivir and colchicine, which have antiviral effects through a variety of different modes of action.

These findings are strongly supportive of accelerated regulatory filings such as the 505(b)(2) pathway permitted by the Food and Drug Administration ("FDA") and other international regulators, for more rapid market authorizations of prospective DehydraTECH-enabled, repurposed antiviral drugs. By comparison, NMEs are generally subjected to more involved regulatory examination and approval processes than non-NMEs.

The work carried out by NRC consisted primarily of nuclear magnetic resonance ("NMR") and Liquid Chromatography-High Resolution Mass Spectrometry ("LC-HRMS") evaluations. NMR spectroscopy is an analytical chemistry method that can determine purity and molecular structures. LC-HRMS uses mass spectrometers and can be used to determine elemental compositions and distinguish between different molecules.

As Lexaria's validating datasets continue to grow, the Company will pursue strategic collaboration opportunities with established pharmaceutical industry partners to incorporate DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated.

DRUG USES:

REMDESIVIR is a well-known nucleotide reverse transcriptase inhibitor, available under the trade name Veklury® from Gilead Sciences Inc., that interferes with the SARS-CoV-2 viral replication life cycle and has received emergency use authorization in many regions of the world for treatment of COVID-19. It is also used to treat hepatitis, Ebola disease and Marburg virus infections.

EBASTINE is an antihistamine drug that has potent effects in inhibiting the SARS-CoV-2 main protease (Mpro, also called the 3CL protease) blocking viral entry into human cells, together with effects to reduce COVID-19 inflammatory reactions. It is also used to treat allergic rhinitis, hives, idiopathic urticaria, and relief from mosquito bites and atopic dermatitis.

BEPRIDIL is used primarily to treat angina pectoris due to coronary heart disease and is indicated to treat chronic stable angina; is being investigated to treat atrial fibrillation; and, in at least one cellular study utilizing Vero E6 cells, was shown to inhibit cytopathogenic effect induces by SARS-CoV-2.

RUPINTRIVIR was originally developed for treatment of rhinoviruses (common colds) and is also being investigated for treatment of picornaviruses, norovirus, and coronaviruses such as SARS-CoV-2.

COLCHICINE is an approved therapeutic with anti-inflammatory effects that is principally used to treat gout and conditions like cardiac inflammation (i.e., pericarditis), but also has potent effects in mitigating the cytokine storm associated with SARS-CoV-2/COVID-19. Colchicine is also sometimes 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. It is also used to treat atrial fibrillation and Periodic Fever Syndromes.

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. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine 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-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. 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 over 50 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/655576/Lexaria-Completes-Successful-Antiviral-Drug-Molecular-Characterization-Study-With-Canadas-National-Research-Council

New patent granted in Japan adds to existing patents in the EU, the U.S., India and Australia

KELOWNA, BC / July 13, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces an additional expansion of its intellectual property portfolio with its first-ever patent granted in Japan.

The patent is titled "Stable ready-to-drink beverage compositions comprising lipophilic active agents" and becomes the 20th patent granted to Lexaria, continuing to add to the Company's considerable intellectual property portfolio.

"With our 20th patent granted worldwide, Lexaria continues to demonstrate the versatility of our DehydraTECH drug delivery platform, encouraging innovation in the consumable liquid category around the world," said Chris Bunka, CEO of Lexaria. "This new patent adds to our existing suite of granted patents spanning the EU, the U.S., India and Australia, and continues to build value for Lexaria shareholders and clients."

This is the third patent granted from Lexaria's third patent family. Lexaria's patent application suite comprises a total of 13 patent families. Active ingredients that may be used under this new patent include non-psychoactive cannabinoids and NSAIDS (e.g., acetylsalicylic acid, ibuprofen, diclofenac, indomethacin, piroxicam).

Lexaria has patent applications progressing in countries around the world with aggregate populations of nearly 4 billion people and will report on further progress as information becomes available.

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. DehydraTECH 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 U.S. 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/655223/Lexaria-Receives-Patent-Protection-in-Japan

KELOWNA, BC / July 5, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW)(CSE: LXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms announces that on June 30, 2021 it made a request to voluntarily delist its common shares from the Canadian Securities Exchange (the “CSE”). It is expected that the close of business on Wednesday, July 7, 2021 will be the final trading day for Lexaria on the CSE. At the open of the trading day on July 8, 2021, the Company’s shares will only trade on the NASDAQ Capital Markets ('Nasdaq').

Since Lexaria's shares began trading on the Nasdaq in January 2021, the overwhelming majority of trading has moved to Nasdaq, providing more liquidity for shareholders than ever before experienced. The Company expects to realize savings in fees and managerial time and effort that were required to maintain a dual listing that can now be redirected into the Company's applied research and development programs, further advancing the business of the Company. For these reasons, Lexaria's management team and Board of Directors have made the decision to voluntarily delist from the CSE, consolidating the trading of its shares to Nasdaq.

All shareholders can continue trading Lexaria's shares on Nasdaq under the symbol “LEXX”. The Company has confirmed that Nasdaq listed securities are designated as a “qualified investment” for the purposes of maintaining Lexaria shares in Canadian Registered Savings Plans, including RRSP, RESP, RRIF, RDSP and TFSA.

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.

INVESTOR CONTACT:

[email protected]

Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/654192/Lexaria-Announces-Voluntary-Delisting-from-the-Canadian-Securities-Exchange-to-Concentrate-Trading-on-the-Nasdaq-Capital-Markets

KELOWNA, BC / June 29, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW)(CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the results of the 2021 Annual Meeting (the 'Meeting').

On June 28, 2021 at 1:00 p.m. (Pacific Time), the Company held the Meeting whereby there were 2,735,413 shares of the Company represented in person or by proxy at the meeting, constituting 53.6% of the Company's issued share capital as at May 3, 2021, being the record date of the Meeting. The matters voted upon at the Meeting and the final voting results are set forth below:

Matter Being Voted On

For

Against

Abstain

Broker Non-Vote

Percent Approved By1

To Elect Chris Bunka as a director

1,389,144

30,938

7,703

1,307,628

97.2%

To Elect John Docherty as a director

1,175,573

245,394

6,818

1,307,628

82.3%

To Elect Nicholas Baxter as a director

1,171,626

249,276

6,883

1,307,628

82.1%

To Elect Ted McKechnie as a director

1,394,635

26,310

6,840

1,307,628

97.7%

To Elect Albert Reese Jr. as a director

1,393,765

27,167

6,853

1,307,628

97.6%

To Appoint Davidson & Company LLP as Auditors

2,713,114

17,792

4,504

0

99.2%

To Approve an amendment to the Company's Equity Incentive Plan for the issuance of an additional 249,143 common shares

975,355

442,816

9,614

1,307,628

68.3%

To ratify the lawful actions of the directors for the past year

1,225,531

55,303

146,951

1,307,628

85.8%

1 Percentage is calculated based on abstained votes being counted as a vote against the resolution

All of the proposals are described in detail in the Company's proxy statement filed with the Securities Exchange Commission via Edgar and with the BC Securities Commission and Ontario Securities Commission via SEDAR on May 14, 2021.

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.

INVESTOR CONTACT:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/653604/Lexaria-Announces-2021-Annual-Meeting-Results

DehydraTECH™ improves delivery into bloodstream of orally administered remdesivir and ebastine in study VIRAL-A20-2

KELOWNA, BC / June 15, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce positive results from its tolerability and pharmacokinetic ("PK") animal study VIRAL-A20-2, evaluating DehydraTECH-enabled remdesivir and ebastine.

These findings build upon Lexaria's recent announcement that remdesivir and ebastine processed with DehydraTECH were effective at inhibiting the COVID-19 SARS-CoV-2 virus using an in vitro screening assay in infected cells in its study VIRAL-C21-3.

"These are the best results Lexaria has ever generated demonstrating our technology's ability to more effectively deliver antiviral drugs when taken orally," said Chris Bunka, CEO of Lexaria. "We are starting to see circulating drug levels in the bloodstream that are twice or even three-times higher with DehydraTECH than without, which could greatly enhance opportunities to treat viral infections via oral drug delivery."

Drug

Drug Class

Cmax** % Improvement

(ng/mL)

Control

(ng/mL)

AUClast*** % Improvement

(hr ng/mL)

Control

(hr ng/mL)

Remdesivir

*(GS-441524)

Nucleotide Reverse Transcriptase Inhibitor

54.5 ± 69.4

110%

(p=0.11)

26.4 ± 8.9

218.3 ± 244.5

82%

(p=0.12)

119.7 ± 35.5

Ebastine

MPro Inhibitor (a.k.a. 3CL Protease Inhibitor)

9.1 ± 5.7

33%

(p=0.17)

6.8 ± 4.4

29.9 ±28.0

204%

(p=0.027)

9.8 ±9.7

The gains in delivery for remdesivir and ebastine exceed those that Lexaria previously reported on December 1, 2020 for darunavir (35% gain) and efavirenz (42% gain), two other antiviral drugs investigated by Lexaria representative of two classes of antiviral therapies (a protease inhibitor and a reverse transcriptase inhibitor) under investigation against SARS-CoV-2/COVID-19 and already in use against HIV/AIDS.

Remdesivir is a well-known nucleotide reverse transcriptase inhibitor, available under the trade name Veklury® from Gilead Sciences Inc., that interferes with the SARS-CoV-2 viral replication life cycle and has received emergency use authorization in many regions of the world for treatment of COVID-19. Ebastine is an antihistamine drug that has potent effects in inhibiting the SARS-CoV-2 main protease (Mpro, also called the 3CL protease) blocking viral entry into human cells, together with effects to reduce COVID-19 inflammatory reactions. Mpro inhibitors are gaining attention in the fight against COVID-19, as announced by Pfizer with their novel compound PF-07304814.

Remdesivir is only available today in injectable form due to poor oral bioavailability, thereby limiting its ease and potential breadth of use commercially. Ebastine and many other MPro inhibitors also face bioavailability challenges when given orally, which Lexaria hopes to change with its technology.

The positive outcomes from study VIRAL-A20-2 may have relevance both for the therapeutic indications of the drugs that were studied as well as for additional antiviral drugs within their classes for indications including and beyond COVID-19.

DehydraTECH-formulated remdesivir and ebastine were administered via oral gavage, each in a single dose of 10 mg/Kg to male Sprague-Dawley rats compared to concentration-matched controls of the same drugs without DehydraTECH formulation. The study was conducted in a total of 40 animals, broken down into four groups of 10 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***"), whereby the rats were evaluated over a period of 48 hours after dosing to derive the measured AUClast over the entire period. Blood quantitation for remdesivir was performed by measuring it in its GS-441524* nucleoside analogue metabolite form because remdesivir is a prodrug that is known to be rapidly converted by host cells into its active form following administration.

The findings were statistically significant only in the case of ebastine AUClast gains upon administration of DehydraTECH formulations versus the concentration matched controls, suggesting that larger sample sizes may have been necessary to overcome the observed variability. Lexaria currently has another tolerability and PK study actively underway in animals (study VIRAL-A20-3) evaluating delivery for three other antiviral drugs of interest with potential utility against SARS-CoV-2/COVID-19.

Additionally, Lexaria is also awaiting results from a molecular characterization study (study VIRAL-MC21-1) testing all formulations from studies VIRAL-A20-2 and VIRAL-A20-3. The Company is planning to pursue expanded in vivo PK and efficacy testing in larger animal populations using the best-performing antiviral drugs from these current investigations to achieve statistical powering of its findings when necessary.

The Company will release results from its ongoing studies as well as plans for future expanded in vivo PK and efficacy modelling as they become available. As Lexaria's validating datasets continue to grow, the Company will pursue strategic collaboration opportunities with established pharmaceutical industry partners allowing them to incorporate DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated.

Chris Bunka, CEO, is responsible for the accuracy of this press release. Study VIRAL-A20-2 was conducted by a leading, independent testing laboratory. 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 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:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/651674/Lexaria-Drug-Delivery-Platform-Enables-up-to-Three-Fold-Increase-in-Oral-Delivery-of-Antiviral-Drugs

  • All studies are using DehydraTECH™ 2.0 formulations for multiple market applications, including antivirals, hypertension, NSAIDs and oral nicotine
  • These studies are part of Lexaria's 2021 applied R&D program intended to enable opportunities for strategic partnerships

KELOWNA, BC / June 9, 2021 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides this progress report on several studies within its 2021 applied research and development (R&D) program. Other studies actively underway and planned will be reported on separately.

VIRAL-A20-2 - A tolerability and pharmacokinetic or "PK" study in animals using antiviral drugs remdesivir and ebastine.
Animal dosing and all in-life procedures and sample analyses have been completed. Data analyses is underway with a view to reporting soon. There were 4 groups of 10 animals dosed to determine if DehydraTECH-enhanced remdesivir and ebastine were well tolerated and enabled improved overall quantity of drug delivery ("Area Under the Curve", or "AUC") relative to non-enhanced controls as Lexaria has successfully evidenced for other antiviral drugs. Lexaria hopes to build on recently announced positive findings from its VIRAL-C21-3 study that evidenced effective inhibition of the COVID-19 SARS-CoV-2 virus using these DehydraTECH-enhanced compounds in an in vitro screening assay.

VIRAL-A20-3 - An additional tolerability and PK study in animals evaluating AUC for 3 other antiviral drugs.
Animal dosing and all in-life procedures have been completed, and sample analyses is ongoing. There were 6 groups of 10 animals dosed in this study examining tolerability and quantity of drug delivery for 3 other antiviral drugs of interest with potential utility against the COVID-19 SARS-CoV-2 virus. This study is expected to generate reportable results during July or August.

VIRAL-MC21-1 - A molecular characterization ("MC") study being performed by Canada's National Research Council.
In this study, Nuclear Magnetic Resonance ("NMR") and Liquid Chromatography-High Resolution Mass Spectrometry ("LC-HRMS") are being applied to 5 DehydraTECH-enhanced antiviral drug formulations currently being investigated by the Company in studies VIRAL-A20-2 and VIRAL-A20-3. Molecular characterization is an important step in determining whether Lexaria's DehydraTECH technology alters the underlying drugs to a degree significant enough to result in formation of a covalently bonded new molecular entity ("NME"). NMEs are generally subjected to more involved regulatory examination and approval processes than non-NMEs. Lexaria has previously reported findings evidencing that NME formation did not occur following DehydraTECH formulation with other substances of interest such as nicotine and cannabidiol ("CBD"). Results from this work are expected to be reported ahead of schedule, by the first half of July.

HYPER-A21-1 and HYPER-A21-2 - Follow on blood pressure testing in animals pursuant to previously reported successful PK study findings.
Most results from these animal studies were released on May 6 and May 20, 2021 respectively demonstrating statistically significant gains in CBD absorption relative to controls using Lexaria's latest DehydraTECH 2.0 formulation innovations. The testing laboratory that performed this work has been engaged to perform certain follow-up work that includes monitoring of real-time animal blood pressure in response to select formulations from these PK evaluations. This work is hoped to complement Lexaria's previous human clinical study findings that have evidenced reduction in blood pressure following DehydraTECH-CBD administration. Animal dosing and in-life procedures have not yet commenced for this additional follow up work, but will be reported when developments warrant.

NSAID-A21-1 - A tolerability and PK study in animals evaluating ibuprofen and naproxen.
Test articles were manufactured in April as planned, contracts were executed in early May with the animal testing laboratory performing this work, and initial animal dosing commenced the week of May 17 ahead of schedule. This work is currently underway with pilot tolerability evaluations in rodents in an effort to determine dosing that evidences superior gastrointestinal tolerability comparing Lexaria's DehydraTECH test articles to concentration-matched controls. Pending a successful outcome of the pilot tolerability investigation, formal pharmacokinetic testing will follow. Reporting from this study work shall be provided when developments warrant.

Oral Nicotine: NIC-C21-1 (now NIC-A21-1) - A tolerability and PK study in animals evaluating oral nicotine.
This study has been renamed NIC-A21-1 following migration from an in vitro cell based study instead to an in vivo study in live anesthetized animals. This will allow Lexaria to perform a superior evaluation of the systemic absorption of nicotine upon oral pouch product dosing in the animals. Human oral pouch dosing of nicotine is a rapidly growing trend in several locations around the world and Lexaria believes this redesigned study will more appropriately measure outcomes. The contract has been signed with the animal testing laboratory that will be performing this work and all study test articles have been manufactured and are in the process of being shipped to the laboratory for dosing purposes. Animal dosing in this study is scheduled to commence in July ahead of the originally stated September/October dosing commencement schedule for NIC-C21-1. Reporting from this study will be provided when developments warrant.

Summary
Lexaria relies on applied R&D programs to generate confirmatory results and data evidencing improved drug delivery characteristics that enable pursuit of commercial opportunities and/or corporate relationships. As such, Lexaria considers advancing these applied R&D studies to be a vital early step towards its goal of establishing commercial relationships with potential industry partners to utilize DehydraTECH within their existing product lines or in the development of new product lines.

All studies referenced within this press release are fully funded from existing Company resources and performed by independent third-party testing laboratories.

The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time with any of its work with antiviral drugs reported herein.

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, 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/651001/Lexaria-Provides-Progress-Report-on-Six-RD-Programs

  • Dosing Is Complete in First of Three Human Clinical Studies Hoped To Validate Lexaria’s Patented Technology for Hypertension Relief
  • Study Tested an Advanced “DehydraTECH™ 2.0” CBD Formulation
  • Second Human Clinical Study, Hyper-H21-2, To Commence Immediately

KELOWNA, BC / June 7, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW)(CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to report that treatment and dosing in its human clinical study (HYPER-H21-1) have been completed ahead of schedule.

HYPER-H21-1 focused on testing DehydraTECH-enabled cannabidiol ("CBD") for potential use as a hypertension treatment alternative. Twenty-four human volunteers aged 45 to 65 were dosed within this study, all of whom tolerated treatment well with no serious adverse events or side effects observed or reported.

"Completing this work in the midst of the COVID-19 pandemic was challenging and we acknowledge and commend the dedication and work ethic of our Europe-based research partners and all parties involved," said Chris Bunka, CEO of Lexaria. "Blood samples from the study volunteers will be shipped this week to our U.S. and Canadian analytical testing laboratory partners, and we expect to complete all sample and data analyses and reporting ahead of schedule, by July or August instead of the end of Q3 as previously indicated."

Study HYPER-H21-1 followed a randomized, double-blinded, controlled design in human volunteers with documented pre-hypertension or mild hypertension. A single 300 mg dose of an advanced "DehydraTECH 2.0" CBD formulation was evaluated relative to a concentration-matched control without Lexaria's DehydraTECH enhancements. The study was conducted by independent, third-party service providers bearing responsibility for all study recruitment, procedures and analytical testing.

Evaluation of time series blood pressure and heart rate analyses were the primary objectives of this study. Important secondary objectives included speed and rate of absorption of the CBD and its main metabolites (pharmacokinetics or "PK" assessments), as well as evaluation of inflammatory markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure is intended to provide mechanistic insight into the anticipated reduction in blood pressure via vasodilation.

The inflammatory assessments (including both anti- and pro-inflammatory biomarkers) may also be applicable to Lexaria's research initiatives in the antiviral therapeutics sector whereby effective anti-inflammatory therapies are also useful in treating diseases like COVID-19 or other common pro-inflammatory conditions.

In addition, Lexaria is pleased to announce that its second human clinical study of 2021, HYPER-H21-2, will begin immediately. The study's 16 human volunteers will be pre- or mildly hypertensive and will received three separate doses of 150 mg each of DehydraTECH 2.0-enabled CBD versus placebo (total dose of 450mg). HYPER-H21-2 includes 24-hour continuous ambulatory (portable) monitoring of blood pressure and heart rate, together with evaluations of central arterial stiffness, physical activity and sleep quality (e.g., total sleep time, total wake time, and sleep efficiency). All treatment and dosing visits in this study should be completed in or around July. The Company expects to complete all sample and data analyses quite rapidly with reporting in late September or thereabouts, though preliminary outcomes may be reported earlier if available.

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. DehydraTECH 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 U.S. 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/650547/Lexaria-Issues-Progress-Report-on-First-Human-Clinical-Study-of-2021-HYPER-H21-1

KELOWNA, BC / June 3, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW)(CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that remdesivir and ebastine processed with DehydraTECH were effective at inhibiting the COVID-19 SARS-CoV-2 virus using an in vitro screening assay in infected cells in Lexaria study VIRAL-C21-3.



"The main purpose of the study was to confirm that Lexaria's DehydraTECH formulation and processing methodology did not negate the known antiviral efficacy of these compounds before proceeding to larger, planned in vivo efficacy testing, said Chris Bunka, CEO of Lexaria Bioscience Corp. "These preliminary findings evidenced SARS-CoV-2 inhibitory performance commensurate with our expectations warranting ongoing and further investigation in animal testing."



This study used one of the most widely applied and informative predictive measures of drug efficacy to measure the half-maximal inhibitory concentration ("IC50") of the drugs when formulated with DehydraTECH. This was an important step towards advancing to animal and ultimately human efficacy testing for the purpose of using DehydraTECH-processed drugs to treat COVID-19.



This study was performed using a primate cell line, VERO-E6, and conducted by a leading independent, US biosafety level 3 testing laboratory that delivers critical services to government and commercial customers. That third party laboratory was responsible for study administration, quality control, and generation of results. Lexaria President John Docherty, Head of R&D, has verified the information within this press release.



Lexaria's antiviral study program may also have benefits beyond COVID-19, including a wide range of other viral disease indications where improved oral delivery performance is needed. The combined market for antiviral drugs is projected to be over USD $44 billion by 2026.1



Remdesivir and ebastine have each shown promise in the fight against COVID-19. Remdesivir is a well-known nucleotide reverse transcriptase inhibitor, available under the trade name Veklury® from Gilead Sciences Inc., that interferes with the SARS-CoV-2 viral replication life cycle and has received emergency use authorization in many regions of the world for treatment of COVID-192. Ebastine is an antihistamine drug that has potent effects in inhibiting the SARS-CoV-2 main protease (Mpro, also called the 3CL protease) blocking viral entry into human cells3, together with effects to reduce COVID-19 inflammatory reactions4. Mpro inhibitors are gaining attention in the fight against COVID-19, as announced by Pfizer with their novel compound PF-073048145.



Both remdesivir and ebastine are characterized by poor aqueous solubility and compromised intestinal absorption and bioavailability when administered orally. Lexaria hopes that its patented DehydraTECH delivery technology will pave the way for better performing oral dosage forms of these and other antiviral drugs, as it has already demonstrated for a range of lipophilic drug molecules including other antiviral agents such as darunavir and efavirenz as previously announced. Lexaria is currently investigating the pharmacokinetic performance of remdesivir and ebastine in its ongoing animal study VIRAL-A20-2, as well as other antiviral drugs of interest against SARS-CoV-2 in its additional ongoing animal study VIRAL-A20-3. The Company will release results from these studies as well as plans for future in vivo efficacy modelling as they become available. The Company is interested in pursuing strategic collaboration opportunities with established pharmaceutical industry partners who may be interested in incorporating DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated.



The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.



1 https://www.globenewswire.com/news-release/2020/02/20/1987756/0/en/Antiviral-Drugs-Market-Worth-USD-44-2-billion-by-2026-at-3-2-CAGR-Rising-Prevalence-of-HIV-to-Fuel-Growth-Fortune-Business-Insights.html



2 https://www.nih.gov/news-events/nih-research-matters/final-report-confirms-remdesivir-benefits-covid-19



3 https://www.researchgate.net/publication/341660698_Targeting_the_SARS-CoV-4



4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7472874/



5 https://cen.acs.org/pharmaceuticals/drug-discovery/Pfizers-novel-COVID-19-antiviral/98/web/2020/09



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. DehydraTECH 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 U.S. 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:

[email protected]

Phone: 866-221-3341



SOURCE: Lexaria Bioscience Corp.




View source version on accesswire.com:
https://www.accesswire.com/650217/Lexarias-DehydraTECHTM-Enabled-Remdesivir-and-Ebastine-Effectively-Inhibit-the-COVID-19-SARS-CoV-2-Virus