LEXXW - Dosing is Complete in Lexaria's Second GLP-1 Human Pilot Study
(TheNewswire)
All three dosing arms have beencompleted.
Kelowna, British Columbia – July 9,2024 – 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”) has now completed all dosing.
The Study is a three-arm, crossover investigationcomparing three 7 mg semaglutide dose formulations:
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DehydraTECH-semaglutide swallowed capsules;and
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for the first time ever, an in-mouth dissolvableDehydraTECH-semaglutide oral tablet.
The final 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 an in-mouthdissolvable tablet. This will be the first study designed toinvestigate whether DehydraTECH-enhanced semaglutide can absorb at anylevel systemically through the sublingual/buccal tissues of the mouthand throat with fewer side effects than from swallowed administration,and with some effective drug delivery into the bloodstream. This is being explored because of the acidicenvironment of the stomach that seriously degrades GLP-1 drugs thatare swallowed, resulting in exceptionally low blood absorption ratesof less than 1% when an absorption technology is not used.
All blood samples collected during the study are now being transportedto the bioanalytical lab for analysis. We anticipate completing theanalysis and announcing the Study results in late August or earlySeptember. Next steps include our evaluation and optimization ofdifferent semaglutide formulations in our already-underway animalstudy , as well as evaluation ofsemaglutide in our upcoming 12-week chronic humanstudy .
“Lexaria is delighted that our contracted clinicalresearch organization was able to complete the active phase of theStudy on schedule,” said Chris Bunka, Chief Executive Officer of theCompany. “The results of this Study are expected to validate ourearlier work with semaglutide, and also to discover whether it ispossible to achieve any absorption of this market-leading GLP-1 drugthrough the tissues of the mouth.”
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 were compound formulated using crushed Rybelsus® tablets strictly for research purposes. The Study isdesigned to measure tolerability and side effects, blood levels of semaglutide, blood glucose andinsulin levels. Blood samples were taken multiple times during thefirst 10 hours post dosing; a final blood draw was taken 24 hoursafter dosing; and a standardized meal was fed to the test subjects ata point in time after dosing. Nine healthysubjects were dosed in each of the first two study arms, and sevenwere dosed in the final study arm.
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 46 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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