LEXXW - Lexaria Summarizes Successful Antiviral Drug Studies and Ongoing Strategy

(TheNewswire)

All objectives evaluatingDehydraTECH TM drugdelivery platform successfully achieved

Kelowna, British Columbia - TheNewswire – July 22, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms is pleased to review its successful 2021 antiviral drugprogram to date and summarize expected next steps.

Lexaria’s objectives in its 2021 antiviral drugexamination program thus far have been to determine whether:

• - DehydraTECH processing of compounds from leadingclasses of antiviral drugs for SARS-CoV-2/COVID-19, HIV/AIDS and otherinfectious diseases could exhibit evidence of superior oral absorptionrelative to controls,

  - DehydraTECH processing of those compounds wouldpreserve expected viral inhibitory performance upon efficacy testingin infected mammalian cells, and

  - DehydraTECH does not alter nor degrade the drugmolecules chemically as to create new molecular entities that could bechallenging to guide through the regulatory approval process.

All three of these objectives have been met.

Lexaria has successfully tested and published summaryresults on five compounds from three antiviral drug classes, and ineach of these drug classes has evidenced significant gains with up toa three-fold increase in oral drug delivery into the bloodstream(“Area Under the Curve” or “AUC”) upon animal testing whenprocessed with DehydraTECH:

Protease Inhibitors (“PI”): Darunavir and Ebastine (AKA an antihistamine and3CL or SARS-CoV-2 main protease “MPro” inhibitor)

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

Tubulin Polymerization andMicrotubule Inhibitor (“TPMI”): Colchicine(AKA an anti-inflammatory)

Lexaria believes that the absorption gains it hasdemonstrated with the above compounds from their respective antiviraldrug classes could have significant commercial potential given thefact that many antiviral drugs exhibit diminished oral bioavailabilityin their available forms today due to poorintestinal uptake and/or significant liver biotransformation. TheDehydraTECH delivery system is designed to overcome thisbioavailability issue.

For example, drugs like colchicine in its currentlyavailable oral form demonstrate bioavailability of about45 %, and are also known to have a narrow therapeuticindex , meaning that the distinctionbetween toxic and non-toxic doses is marginal. There could besignificant benefits in allowing its dosing to be reduced whilemaintaining therapeutic delivery levels.  DehydraTECH formulations ofantiviral compounds such as colchicine have the potential to lead tosignificantly improved bioavailability while allowing for loweroverall dosing requirements and improved safety and tolerability. The majority of drugs that are currently delivered via injectioncould also experience lower costs of administration and larger marketpotential if delivery characteristics were enhanced sufficiently toallow for oral dosing.

The next steps in Lexaria’s DehydraTECH antiviraldrug 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 isplanning, subject to further investigation to select lead compoundsbased on our work to-date for this effort. TheCompany will release further plans and results related to theseupcoming studies as they become available.

Lexaria is working diligently on a comprehensive,multi-pronged program that is intended to demonstrate pivotalproof-of-concept safety, efficacy and formulation/scalabilityfeasibility data to prospective pharmaceutical industry partners witha view to creating opportunities for expanded, collaborative productdevelopment. The Company is interested inpursuing strategic collaboration opportunities with establishedpharmaceutical industry partners who may be interested inincorporating DehydraTECH technology with antiviral drugs includingand/or similar to those that are currently being investigated. Lexariawould like to evidence that DehydraTECH works to enhance the oraldelivery characteristics of the drugs mentioned above and potentiallyothers which are used to fight many virus triggered diseases,including but not limited to shingles, influenza and viral forms ofgastroenteritis, hepatitis, meningitis, and pneumonia.

Antiviral Drug Background andDehydraTECH Formulation Strategy

The first antiviral drug was approved for use in theUSA in 1963, and over 90 additional antiviral drugs have beenapproved since, with thousands ofother antiviral inhibitors having been proposed. Eleven of theapproved drugs are used to treat more than one infectious disease,illustrating that some of these drugs are effectively used formultiple applications.

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

Of note, “antiviral drugs from the same drug groupshare similar mechanisms of drug action to inhibit viral reproduction during the viral lifecycle .” Thisphenomenon is a crucial component to Lexaria’s strategy ofevidencing that DehydraTECH improves the delivery characteristics ofmany drugs from the classes Lexaria has investigated, potentiallyassisting in their efficacy for both their original approved use, aswell as for use treating additional health indications if/when thatdelivery performance has been enhanced.

For example, there are six mainclasses of antiviral drugs used totreat HIV, including drugs from the PI and RTI classes, above. Thereare 37.7 million people currently known to be infected with HIV and36.3 million people havedied from HIV/AIDS since thebeginning of the epidemic, roughly equal to the entire population ofCanada. There are over 200 drugs approved by theFDA to treat HIV/AIDS. Because of themassive regulatory and scientific response to the onset of HIV, thisdisease is thankfully killing fewer people now than in the past,although significant demand remains for safe and effective HIV/AIDStherapies that can be used on a chronic treatment basis to preservelife.

Influenza is caused by viruses even though vaccineshave been widely available for years and remain the #1 recommendedmethod to prevent infection. Despite that, between 290,000 and 650,000people die every year fromseasonal influenza . The 1918-19influenza epidemic is thought to have killed up to 50 million people,and the 1958 and 1968 influenza epidemics are thought to have killedbetween 1 and 4 million peopleeach . There are only 4 drugs approved bythe FDA to treat influenza; three ofthem belong to the Neuraminidase Inhibitors class and must beadministered by injection, and one belongs to the PA endonucleasesinhibitor class and is taken as an oral tablet.

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

Regardless of the efficacy and availability of vaccinesto prevent many viral infections including influenza vaccines thathave been widely available since1945 , thousands of people die everyyear because they are infected with viruses while unvaccinated, orlive in large areas of the world where vaccines are not available. Itis currently estimated that over99% of the over 200,000deaths in the US since January 1,2021 from SARS-CoV-2 have occurred in unvaccinated victims,demonstrating the vital current need for successful treatment optionsfor those who are unvaccinated.

Based on all these facts, the need and demand foreffective antiviral drugs via oral delivery that are available to all,has never been more profound than today. Lexaria has progressedsignificantly in evidencing that its DehydraTECH delivery technologycan sufficiently enhance the usable fraction of known antiviral drugsthat reach the bloodstream so that they can safely and moreeffectively do what they are designed to accomplish. Lexaria continuesto evaluate the data generated from its 2021 antiviral drug programand will make an announcement regarding next steps as soon aspossible.

The Company is not making any express or implied claimsthat its products have the ability to eliminate, cure or contain theCOVID-19 pandemic (or SARS-CoV-2 or novel Coronavirus) or any othervirally induced diseases at this time.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.’s proprietary drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting healthier oralingestion methods and increasing the effectiveness of fat-solubleactive molecules, thereby lowering overall dosing. The Company’s technology can be applied to manydifferent ingestible product formats, including foods, beverages, oralsuspensions, tablets, and capsules. DehydraTECH has repeatedlydemonstrated since 2016 with cannabinoids and nicotine the ability toincrease 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 befurther evaluated for orally administered bioactive molecules,including anti-virals, cannabinoids, vitamins, non-steroidalanti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensedDehydraTECH to multiple companies including a world-leading tobaccoproducer for the development of smokeless, oral-based nicotineproducts and for use in industries that produce cannabinoid beverages,edibles, and oral products. Lexaria operates a licensed in-houseresearch laboratory and holds a robust intellectual property portfoliowith 20 patents granted and approximately 60 patents pendingworldwide. For more information, please visit www.lexariabioscience.com .

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press releaseincludes forward-looking statements. Statements as such term isdefined under applicable securities laws. These statements may beidentified by words such as "anticipate," "if,""believe," "plan," "estimate,""expect," "intend," "may,""could," "should," "will," and othersimilar expressions. Such forward-looking statements in this pressrelease include, but are not limited to, statements by the companyrelating the Company’s ability to carry out research initiatives,receive regulatory approvals or grants or experience positive effectsor results from any research or study. Such forward-looking statementsare estimates reflecting the Company's best judgment based uponcurrent information and involve a number of risks and uncertainties,and there can be no assurance that the Company will actually achievethe plans, intentions, or expectations disclosed in theseforward-looking statements.  As such, you should not place unduereliance on these forward-looking statements. Factors which could cause actualresults to differ materially from those estimated by the Companyinclude, but are not limited to, government regulation and regulatoryapprovals, managing and maintaining growth, the effect of adversepublicity, litigation, competition, scientific discovery, the patentapplication and approval process, potential adverse effects arisingfrom the testing or use of products utilizing the DehydraTECHtechnology, the Company’s ability to maintain existingcollaborations and realize the benefits thereof, delays orcancellations of planned R&D that could occur related to pandemicsor for other reasons, and other factors which may be identified fromtime to time in the Company's public announcements and periodicfilings with the US Securities and Exchange Commission on EDGAR. Thereis no assurance that any of Lexaria’s postulated uses, benefits, oradvantages for the patented and patent-pending technology will in factbe realized in any manner or in any part. No statement herein has beenevaluated 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 containedin this release speak only as of the date hereof, and the Companyexpressly disclaims any obligation to update any forward-lookingstatements contained herein, whether as a result of any newinformation, future events, changed circumstances or otherwise, exceptas otherwise required by law.

INVESTOR CONTACT:

ir@lexariabioscience.com

Phone: 250-765-6424, ext202

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