LEXXW - Lexarias Human Nicotine Study Nearing Start Date
(TheNewswire)
Lexaria is targeting the oralnicotine pouch category, one of the fastest growing segments of thenicotine industry.
Kelowna, British Columbia – TheNewswire - July 13, 2022 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or“Lexaria”), a global innovator in drug delivery platformsannounces the pending start of its upcoming human nicotine studyNIC-H22-1. Lexaria expects to evidence that processing purifiednicotine with its patented drug delivery technology,DehydraTECH TM , leads to enhanced oral-tissue absorption and reducednegative experiences.
Study NIC-H22-1 is a minimum 36-person humanpharmacokinetic (“PK”) randomized, double blinded, cross-overstudy to compare Lexaria’s DehydraTECH-nicotine pouch performance tothat of existing leading brands currently sold in the US such as ON! and Zyn .Objective data collection from blood samples that will evidence Tmax , Cmax , and AUC is the primary objectiveof the study. Secondary objectives include extensive subjectiveevaluations related to throat burn, user experience, and more.
The nicotine test article ingredient manufacturing andDehydraTECH processing have been completed and those processedmaterials have been received by the third-party pouch manufacturingcompany for filling and packaging. Independent Review Board approvaland subsequent human dosing will be the next two major steps in thisstudy.
A s reported on March 8,2022 , Lexaria received its first everpatent granted to use DehydraTECH to more efficiently deliver nicotinethrough buccal tissue absorption, in Australia. A similar patentfiling has been made in the USA and Lexaria believes that potentialpatent award could support significant competitive advantages in thenicotine white pouch category, as well as other oral nicotine productformats such as pills, tablets, lozenges, capsules, gums andsprays.
The oral nicotine pouch category is one of the fastestgrowing segments of the nicotine industry due in part to its reduced risk healthoutcomes as noted by the Food andDrug Administration (“FDA”). This delivery method, in the white pouchformat specifically, which avoidsharmful lung outcomes experienced by smokers or vapers, involvesabsorption primarily through the buccal tissues of the mouth, ofpurified nicotine that has been separated from most other harmfulcompounds in the tobacco leaf. The global market for the oral nicotinepouch category was US$2.33 billion in 2020 and is growing at a rapidCAGR of 30.7% and is expected to reach $21.84billion in 2027.
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 25 patents granted andover 50 patents pending worldwide. For more information, please visit 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 which could cause actual resultsto differ materially from those estimated by the Company include, butare not limited to, government regulation and regulatory approvals,managing and maintaining growth, the effect of adverse publicity,litigation, competition, scientific discovery, the patent applicationand approval process, potential adverse effects arising from thetesting or use of products utilizing the DehydraTECH technology, theCompany’s ability to maintain existing collaborations and realizethe benefits thereof, delays or cancellations of planned R&D thatcould occur related to pandemics or for other reasons, and otherfactors which may be identified from time to time in the Company'spublic announcements and periodic filings with the US Securities andExchange Commission on EDGAR. There is no assurance that any ofLexaria’s postulated uses, benefits, or advantages for the patentedand patent-pending technology will in fact be realized in any manneror in any part. No statement herein has been evaluated by the Food andDrug Administration (FDA). Lexaria-associated products are notintended to diagnose, treat, cure or prevent any disease. Anyforward-looking statements contained in this release speak only as ofthe date hereof, and the Company expressly disclaims any obligation toupdate any forward-looking statements contained herein, whether as aresult of any new information, future events, changed circumstances orotherwise, except as otherwise required by law.
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