LEXXW - Dosing Continues in Lexaria's Second GLP-1 Human Pilot Study
(TheNewswire)
Second study arm dosing is nowcomplete.
Kelowna, British Columbia – June 5,2024 – TheNewswire – Lexaria Bioscience Corp. (Nasdaq: LEXX &LEXXW) (the “Company” or “Lexaria”), a global innovator indrug delivery platforms announces that human pilot study #2,GLP-1-H24-2, (the “Study”) continues to make progress and thesecond round of dosing for all nine study participants is nowcomplete. Lexaria expects to complete the third (final) arm of theStudy in early July
The Study is a three-arm, crossover investigation thatwill compare three 7 mg semaglutide dose formulations:
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DehydraTECH-semaglutide swallowed capsules (alsocomplete); and
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for the first time ever, an in-mouth dissolvableDehydraTECH-semaglutide oral tablet.
The second DehydraTECH Study arm used aRybelsus® composition processed with DehydraTECH that is compliantwith the U.S. Food and Drug Administration's Inactive IngredientDatabase ("FDA IID"), delivered within swallowed capsules.
Lexaria’s final DehydraTECH Study arm willinvestigate an oral dissolvable tablet formulation, also compliantwith the FDA IID, with DehydraTECH powered semaglutide fromRyblesus®. This will be the first study designed to investigatewhether DehydraTECH-enhanced semaglutide can absorb at any levelsystemically into the sublingual/buccal tissues of the mouth andthroat with fewer side effects than from swallowed administration, andwith some effective drug delivery into the bloodstream. This is because of the acidic environment of the stomach thatseriously degrades GLP-1 drugs that are swallowed, resulting inexceptionally low blood absorption rates of less than 1% when anabsorption technology is not used.
In the previously announcedhuman pilot study with 7 volunteers,Lexaria demonstrated superior pharmacokinetic ("PK") oraldelivery performance of the DehydraTECH-enhanced GLP-1 drugsemaglutide available commercially in the branded product Rybelsus®.
About the Study
Design characteristics of the Study are comparable toLexaria’s initial human pilotstudy . The DehydraTECH-semaglutidetest articles will be compound formulated using crushedRybelsus® tablets strictly for researchpurposes. The Study is designed to measure tolerability and sideeffects, blood levels of semaglutide, and blood glucose levels. Bloodsamples will be taken multiple times during the first 10 hours postdosing; a final blood draw will be taken 24 hours after dosing; and astandardized meal will be fed to the test subjects at a point in timeafter dosing. Nine healthy subjects are expectedto be dosed with each test article with roughly a 30-day “washout”interval between each dosing visit.
About Semaglutide
Rybelsus® (semaglutide) is the only GLP-1 drugapproved by the FDA for oral dosing to treat diabetes and weightloss. The FDA has also approved semaglutide marketed as Ozempic® andWegovy®, administered byinjection , to treat diabetes and weight loss.All three of these drugs are owned and manufactured by NovoNordisk®.
About Lexaria Bioscience Corp. &DehydraTECH
DehydraTECH™ is Lexaria’s patented drug deliveryformulation and processing platform technology which improves the wayactive pharmaceutical ingredients (APIs) enter the bloodstream throughoral delivery. Since 2016, Lexaria has developed and investigatedDehydraTECH with a variety of beneficial molecules in oral and topicalformats. DehydraTECH has repeatedly demonstrated the ability toincrease bio-absorption and has also evidenced an ability to deliversome drugs more effectively across the blood brain barrier, whichLexaria believes to be of particular importance for centrally activecompounds. Lexaria operates a licensed in-house research laboratoryand holds a robust intellectual property portfolio with 43 patentsgranted and many 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. The Company provides links tothird-party websites only as a courtesy to readers and disclaims anyresponsibility for the thoroughness, accuracy or timeliness ofinformation at third-party websites. 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 or links to third-party websitescontained herein, whether as a result of any new information, futureevents, changed circumstances or otherwise, except as otherwiserequired by law.
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