LEXXW - Lexaria's DehydraTECH-CBD (TM) Achieves Superior Human Blood Absorption Levels
(TheNewswire)
Kelowna, British Columbia – TheNewswire - December 21, 2022 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms is pleased to announce it has demonstrated superiorcannabidiol (“CBD”) blood absorption levels from its patented DehydraTECH-CBD™ relative to those of published,pharmaceutical-grade CBD industry comparators in its recentlycompleted, multi-week human clinical hypertension studyHYPER-H21-4.
In a 2017 randomized clinical trial that evaluated anon-Lexaria, pharmaceutical-grade, plant-derived CBD formulationpublished by Devinski et. al. , an average blood plasma CBD level of 23.0 ng/mL wasevidenced after 22 days (so-called, “steady state” 1 ) of dailydosing at a 5 mg/kg CBD dose level. By comparison, in Lexaria’s2022 HYPER-H21-4 hypertension study, a 45.8% higher average bloodplasma level (33.3 mg/mL) was reached at DehydraTECH-CBD’s lowestdose level tested of just 3.38 mg/kg, climbing to a blood plasma levelthat was 133.4% higher (53.7 ng/mL) at its highest dose level testedof 4.46 mg/kg.
The Devinsky publication also examined higher CBDdosing at a level of 10 mg/kg, evidencing a blood level of 62.1 ng/mL. Although Lexaria’s HYPER-H12-4 study did not see the need to doseas high as 10 mg/kg, the data trend observed at its 3.38 and 4.46mg/kg dose levels extrapolated linearly to 10 mg/kg would be expectedto reach a level of 149.5 ng/mL; a 141% improvement over the DevinskyCBD formulation.
Similarly, a 2019 study published by Wheless et. al ., also evaluatedaverage CBD levels in blood following dosing tosteady-state 1 over a multi-day period, using a differentpharmaceutical-grade, synthetic CBD formulation. At a 10 mg/kg doselevel in the Wheless study, the non-Lexaria synthetic CBD reached alevel within blood plasma of 91 ng/mL.; DehydraTECH-CBD absorptionoutperformed this synthetic CBD by 64% improvement upon linearextrapolation.
“DehydraTECH-CBD has repeatedly shown that it can beadministered at much lower dose levels than other CBD formulations toachieve effective levels within the blood stream, as supported by thispharmaceutical-industry peer comparison,” said Chris Bunka, CEO ofLexaria Bioscience Corp. “This is extremely important to patientshoping to achieve positive health outcomes while using lower levels ofmedication with no serious side effects and also important to Lexariaas we pursue FDA registration of DehydraTECH-CBD.”
Additional study endpoint analyses as described in thecomplete study protocol are still underway and any relevant materialfindings will be reported upon in due course as these findings becomeavailable. It is highly likely that multipleadditional datasets will be released in January through March of2023.
Lexaria’s HYPER-H21-4 study was a randomized, double-blinded, placebo-controlled, cross-overstudy of a total of 66 male and femalevolunteers between the ages of 40-70. All study participants receivedDehydraTECH-CBD every day for a total of 5 weeks. Blood CBD levelsreported herein from DehydraTECH-CBD administration were measuredprior to dosing, as was the case reported in the Devinsky article,whereas the Wheless article did not specify blood sampling timingrelative to dosing. The complete HYPER-H21-4 study protocol has beenpublished and is available at PubMed .
1 Steady State
In Pharmacology, “steady-state” refersto the amount of time required before aconsistent dose of drug achieves a stable blood plasma level. Whilethe Devinsky and Wheless study references examined CBD levels in theblood at different points in time compared to Lexaria’s study, allthree studies would have been expected to have reached steady-statepharmacokinetics after sustained dose administration by the points intime at which sampling was performed. CBD is generally thought toreach steady-state dose levels within several days of consistent dosing.
ABOUT LEXARIA BIOSCIENCE CORP.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting more effectiveoral delivery. Since 2016, DehydraTECH has repeatedly demonstrated theability to increase bio-absorption with cannabinoids, antiviral drugs,PDE5 inhibitors and more. DehydraTECH has also evidenced an ability todeliver some drugs more effectively across the blood brain barrier.Lexaria operates a licensed in-house research laboratory and holds arobust intellectual property portfolio with 27 patents granted androughly 50 patents pending worldwide. For more information, pleasevisit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKINGSTATEMENTS
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 arenot limited to, statements by the company relating the Company’sability to carry out research initiatives, receive regulatoryapprovals or grants or experience positive effects or results from anyresearch or study. Such forward-looking statements are estimatesreflecting the Company's best judgment based upon current informationand involve a number of risks and uncertainties, and there can be noassurance that the Company will actually achieve the plans,intentions, or expectations disclosed in these forward-lookingstatements. As such, you should not place undue reliance on theseforward-looking statements. Factors whichcould cause actual results to differ materially from those estimatedby the Company include, but are not limited to, government regulationand regulatory approvals, managing and maintaining growth, the effectof adverse publicity, litigation, competition, scientific discovery,the patent application and approval process, potential adverse effectsarising from 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. TheCompany provides links to third-party websites only as a courtesy toreaders and disclaims any responsibility for the thoroughness,accuracy or timeliness of information at third-party websites. TheCompany only releases select, incomplete data from its study programs.There is no assurance that any of Lexaria’s postulated uses,benefits, or advantages for the patented and patent-pending technologywill in fact be realized in any manner or in any part. No statementherein 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 containedin this release speak only as of the date hereof, and the Companyexpressly disclaims any obligation to update any forward-lookingstatements or links to third-party websites contained herein, whetheras a result of any new information, future events, changedcircumstances or otherwise, except as otherwise required bylaw.
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