LEXXW - Lexaria Awards CRO Contract For 12-Week DehydraTECH GLP-1 Chronic Human Study
(TheNewswire)
Weight Loss and Blood SugarReduction are Major Efficacy Objectives
Kelowna, British Columbia – June18, 2024 – TheNewswire– Lexaria Bioscience Corp. (Nasdaq: LEXX,LEXXW) (the “Company” or “Lexaria”), a global innovator indrug delivery platforms announces it has nowhired a contract research organization (“ CRO ”) to overseeexecution of the Company’s 12-week chronic study GLP-1-H24-4, (the“ Study ”) which will evaluate various DehydraTECH-GLP-1(glucagon-like peptide) formulations and other treatments withefficacy objectives of weight loss, blood sugar reduction, andmore.
Study preparations with the CRO have commenced pursuantto an initial start-up agreement under which a number of activitieswill occur such as full clinical protocol design and writing inconsultation with medical experts, regulatory authority submissions,and data management planning.
“This Study will be the most comprehensive andimpactful GLP-1 investigation that Lexaria has ever undertaken,”said John Docherty, President of Lexaria Bioscience Corp. “Thegreatly expanded scope compared to our previous studies will allow usto investigate DehydraTECH-GLP-1 safety and efficacy over an extendedtreatment duration to significantly broaden our knowledge ofDehydraTECH’s ability to potentially improve the effectiveness andtolerability of this world-leading class of drugs.”
The Study will be conducted using a number of clinicalinvestigational sites in Australia as a registrational Phase 1b studywithin Australian clinical regulatory authority regulations. Uponcompletion, the Study is expected to be equally regarded as a Phase 1bregistrational study by the U.S. Food and Drug Administration(“FDA”).
About The Study
The currently-planned design of the Study has beenexpanded to include five active treatment arms, each with 16 diabeticpatients (80 patients in total), with each patient dosed orally daily,subject to change once the final protocol is complete.
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Rybelsus® as positive control;
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DehydraTECH-cannabidiol (“CBD”);
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DehydraTECH-semaglutide;
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DehydraTECH-CBD combined with DehydraTECH-semaglutide;and,
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DehydraTECH-tirzepatide.
An important component of this Study will be the factthat Lexaria intends to test DehydraTECH-GLP-1 formulations preparedusing pure GLP-1 drug substances such as semaglutide and the dualaction GLP-1 / GIP (glucose-dependent insulinotropic peptide) agonisttirzepatide without the need to create compound formulations using thecorresponding commercially approved products Rybelsus® and Zepbound®respectively to render the DehydraTECH versionsto be studied. As such, this Study will allow DehydraTECH safety andefficacy to be tested without the Rybelsus® enabling ingredientsalcaprozate sodium (“SNAC”), with the ability to demonstrateDehydraTECH effectiveness alone.
Lexaria reminds its followers that our 2022 diabetes studyDIAB-A22-1 , utilizing a never-before-usedformulation variant of DehydraTECH-CBD, evidenced weight loss of 7%and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during amulti-week rodent study without the addition of any GLP-1 drugs.Lexaria is anxious to discover whether the addition of DehydraTECH-CBDto a GLP-1 weight loss program might offer some combination ofimproved weight loss and/or reduced side effects as compared to GLP-1alone.
In its first-ever GLP-1 study in humans reported in January,2024 , Lexaria discovered thatDehydraTECH processing of Rybelsus®-branded semaglutide, after asingle dose, improved blood sugar control and reached higher levels ofsemaglutide measured in blood, than did Rybelsus® itself. Lexaria isanxious to discover whether this improved pharmacokinetic performancemight lead to improved weight loss and/or blood-sugar control comparedto Rybelsus® alone after multi-week dosing.
The Company will provide further updates when themanufacturing of all clinical test articles; the Research EthicsCommittee review; and the Australian Therapeutic Goods Administrationnotification have each been completed. Once protocol development andthese milestones have been achieved, the Company will be able to moreaccurately estimate dates for first patient dosing and for Studycompletion.
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, 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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