LEXXW - Lexaria Drug Delivery Platform Enables up to Three-Fold Increase in Oral Delivery of Antiviral Drugs

(TheNewswire)

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

Kelowna, British Columbia - TheNewswire - June 15, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (CSE:LXX) (CNSX:LXX.CN) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms, is pleased to announce positive results from itstolerability and pharmacokinetic (“PK”) animal study VIRAL-A20-2,evaluating DehydraTECH-enabled remdesivir and ebastine.

These findings build upon Lexaria’s recentannouncement that remdesivir and ebastine processed with DehydraTECHwere 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 evergenerated demonstrating our technology’s ability to more effectivelydeliver antiviral drugs when taken orally,” said Chris Bunka, CEO ofLexaria. “We are starting to see circulating drug levels in thebloodstream that are twice or even three-times higher with DehydraTECHthan without, which could greatly enhance opportunities to treat viralinfections via oral drug delivery.”

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

Remdesivir is a well-known nucleotide reversetranscriptase inhibitor, available under the trade name Veklury® fromGilead Sciences Inc., that interferes with the SARS-CoV-2 viralreplication life cycle and has received emergency use authorization inmany regions of the world for treatment ofCOVID-19 .  Ebastine is anantihistamine drug that has potent effects in inhibiting theSARS-CoV-2 main protease (Mpro, also called the 3CL protease) blockingviral entry into humancells , together with effects toreduce COVID-19 inflammatoryreactions .   Mpro inhibitors aregaining attention in the fight against COVID-19, as announced byPfizer with their novel compoundPF-07304814 .

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

The positive outcomes from study VIRAL-A20-2 may haverelevance both for the therapeutic indications of the drugs that werestudied as well as for additional antiviral drugs within their classesfor indications including and beyond COVID-19.

DehydraTECH-formulated remdesivir and ebastine wereadministered via oral gavage, each in a single dose of 10 mg/Kg tomale Sprague-Dawley rats compared to concentration-matched controls ofthe same drugs without DehydraTECH formulation. The study wasconducted in a total of 40 animals, broken down into four groups of 10per test article.

The study evaluated peak concentration (“MaximumConcentration” or “Cmax”**) and total drug delivery into therodent bloodstream (“Area Under the Curve” or “AUClast***”),whereby the rats were evaluated over a period of 48 hours after dosingto derive the measured AUClast over the entire period. Blood quantitation for remdesivir was performed by measuringit in its GS-441524* nucleoside analogue metabolite form becauseremdesivir is a prodrug that is known to be rapidly converted by hostcells into its active form following administration.

The findings were statistically significant only in thecase of ebastine AUClast gains upon administration of DehydraTECHformulations versus the concentration matched controls, suggestingthat larger sample sizes may have been necessary to overcome theobserved variability.  Lexaria currently has another tolerability andPK study actively underway in animals (study VIRAL-A20-3) evaluatingdelivery for three other antiviral drugs of interest with potentialutility against SARS-CoV-2/COVID-19.

Additionally, Lexaria is also awaiting results from amolecular characterization study (study VIRAL-MC21-1) testing allformulations from studies VIRAL-A20-2 and VIRAL-A20-3. The Company isplanning to pursue expanded in vivo PK and efficacy testing in largeranimal populations using the best-performing antiviral drugs fromthese current investigations to achieve statistical powering of itsfindings when necessary.

The Company will release results from its ongoingstudies as well as plans for future expanded in vivo PK andefficacy modelling as they become available.  As Lexaria’svalidating datasets continue to grow, the Company will pursuestrategic collaboration opportunities with established pharmaceuticalindustry partners allowing them to incorporate DehydraTECH technologywith antiviral drugs including and/or similar to those that arecurrently being investigated.

Chris Bunka, CEO, is responsible for the accuracy of thispress release. Study VIRAL-A20-2 was conducted by a leading,independent testing laboratory. The Company is not making any express or implied claims thatits 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’stechnology can be applied to many different ingestible productformats, 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 19 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.

TheCSE has not reviewed and does not accept responsibility for theadequacy or accuracy of this release.

INVESTOR CONTACT:

ir@lexariabioscience.com

Phone: 250-765-6424, ext202

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