LEXXW - Lexaria Receives Ethics Review Board Approval to Begin New GLP-1 Study
(TheNewswire)
Human Pilot Study #2 (GLP-1-H24-2)Approved
Kelowna, British Columbia – TheNewswire – April 16, 2024 –Lexaria Bioscience Corp. (Nasdaq: LEXX; LEXXW) (the “Company” or“Lexaria”), a global innovator in drug delivery platforms, announces approval has been received from anindependent third-party ethics review board, for human pilot study #2(the “Study”), investigating GLP-1 drugs and DehydraTECH.
Subject recruitment will begin immediately and theCompany will announce as soon as the first dosing has begun, expectedwithin 30 days or less. The Company anticipates completing the Studythis summer.
The Study will be performed in up to 9 healthyvolunteers and will study a single 7 mg dose of Rybelsus®(semaglutide) against two different, concentration-matched 7 mgDehydraTECH-enabled semaglutide formulations from crushedRybelsus®.
One DehydraTECH Study arm will use a Rybelsus®composition processed with DehydraTECH that is compliant with the U.S.Food and Drug Administration’s Inactive Ingredient Database (“FDAIID”), delivered within swallowed capsules. This arm will beotherwise similar to the first DehydraTECH GLP-1 human pilot studyconducted that evidenced higherdelivery of semaglutide into blood with superior blood glucose controland better tolerability than wasachieved with Rybelsus®.
The second DehydraTECH Study arm will investigate anoral dissolvable tablet formulation, also compliant with the FDA IID,with DehydraTECH powered semaglutide from Ryblesus®. This will be thefirst study designed to investigate whether DehydraTECH-enhancedsemaglutide can effectively absorb into the sublingual/buccal tissuesof the mouth and throat with fewer side effects than from swallowedadministration, and with some effective level of bloodabsorption.
Tolerability, blood absorption levels (pharmacokineticsor “PK”), and blood sugar control will all be evaluated. TheDehydraTECH compositions for this study will be compound-formulatedusing commercially available Rybelsus® tablets as the semaglutideinput material.
“I am excited about this Study; the Lexariascientific team believes that a dissolvable oral tablet that deliversan effective fraction of semaglutide along with reduced side effectscould potentially offer valuable benefits to the pharmaceuticalindustry that might lead to a higher likelihood of favorable strategicpartnering with leading industry players in GLP-1,” said ChrisBunka, CEO of Lexaria. “Most GLP-1 drugs sold today are administeredby painful and expensive injection devices. More effective andtolerable oral delivery of GLP-1 drugs could be extremely valuable topatients and to industry.”
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 41 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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