LEXXW - Lexaria's Human Clinical Nicotine Study Completes Dosing as Planned
(TheNewswire)
Kelowna, British Columbia – TheNewswire - May 8, 2023 –Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms announces that dosing of the targeted36 subjects in its human clinical oral nicotine study NIC-H22-1 hasbeen completed.
Human study NIC-H22-1 represents the culmination ofseveral years of work performed by Lexaria on oral nicotineformulations as an alternative to vaping or smoking and may entice themore rapid commercial adoption and distribution of Lexaria’spatented DehydraTECH absorption technology in an industry sorelylacking in oral uptake and performance optimizing innovation for manyyears.
The dangers of cigarette smoking are well known andresult in the death of 7 million people peryear . Nicotine vaping was originally hopedto help wean people off cigarette use but has had mixed results indoing so, and vaping has also been associated with serious healthrisks. Nicotine vaping is becoming increasingly controversial and isseverely limited in certain countries and was, for instance, just banned inAustralia and is either banned or restrictedin many other countries . By comparison, Lexaria’s DehydraTECH-nicotine is alreadypatent granted for oral nicotine delivery in Australia and pending innumerous other countries. The white pouch category , as tested in study NIC-H22-1, is one of the fastest growing, tobacco-free alternatives to smoking and vaping.
Lexaria’s DehydraTECH-powered purified nicotine whitepouch formulation contains no tobacco. DehydraTECH-nicotine hasalready shown in multiple sets of animal testing that it can be up to 10-times to 20-timesfaster and able to deliver up to 10-fold higher levels of nicotine intoblood plasma from oral absorption thanconcentration matched controls. If the findings from study NIC-H22-1also show similar improved performance, this could facilitate a moresatisfying oral nicotine experience than any of the leading brandssold around the world today which all rely on outdated formulationtechnology. Speed of onset is of vital importance to nicotine usersand Lexaria’s DehydraTECH-nicotine has demonstrated superiority inthis regard.
Nicotine Plasma Levels(ng/mL) - DehydraTECH vs. Control From Lexaria’s Earlier AnimalStudy
The oral nicotine pouch category is of intense interestto Lexaria and the nicotine products industry, and its growth is duein part to its reduced risk healthoutcomes as noted by the Food and DrugAdministration (“FDA”). This delivery method, in the white pouch format specifically, whichavoids harmful lung outcomes experienced by smokers or vapers,involves absorption primarily through the buccal and sublingualtissues of the mouth, of purified nicotine that has been separatedfrom most other harmful compounds in the tobacco leaf. The globalmarket for the oral nicotine pouch category was US$2.33 billion in2020 and is growing at a rapid CAGR of 30.7% and is expected to reach $21.84billion in 2027.
About Study NIC-H22-1.
Study NIC-H22-1 is a human pharmacokinetic randomized,double blinded, cross-over study conducted in aminimum of 36 human volunteers that are current cigarette smokers,wherein each person visited the laboratory to be dosed three timesover several weeks. During each visit only one oral nicotine pouch wasadministered and evaluated: either DehydraTECH-nicotine; On! brandmanufactured by Altria; or Zyn brand manufactured by Swedish Match.While 36 people have to date completed their dosing, Lexaria expects asmall number of additional person(s) who were over enrolled into thestudy to also complete dosing in the immediate future.
The primary study objectives are to determine thequantity of nicotine in blood at various time points and vital-signdata collection including blood pressure, heart rate and respiratoryrate. S ubjective evaluations related to throatburn, user experience, gastrointestinal experience and more are alsobeing conducted.
The study is fully funded from internal companyresources. Sample and data analysis is alreadyunderway and will be reported upon as soon as possible and Lexaria will provide further updates and anyrelevant material findings in due course from this study as theybecome available.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream through oral delivery. Since2016, DehydraTECH has repeatedly demonstrated the ability to increasebio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors andmore. DehydraTECH has also evidenced an ability to deliver some drugsmore effectively across the blood brain barrier. Lexaria operates alicensed in-house research laboratory and holds a robust intellectualproperty portfolio with 30 patents granted and many patents pendingworldwide. 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 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 couldcause actual results to differ materially from those estimated by theCompany include, but are not limited to, government regulation andregulatory approvals, managing and maintaining growth, the effect ofadverse publicity, litigation, competition, scientific discovery, thepatent 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. 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 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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