News Release
Dosing Begins in Lexaria's Comprehensive GLP-1 Animal Study
Lexaria Bioscience Corp.
Study WEIGHT-A24-1 will evaluate DehydraTECH-processed pure semaglutide and liraglutide Will DehydraTECH processing result in higher brain absorption of GLP-1 drugs? Kelowna, British Columbia – May 17, 2024 – TheNewswire – Lexaria Bioscience Corp. (Nasdaq: LEXX & LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms announces that d osing has begun in the 12-week animal study WEIGHT-A24-1 (the “ Study ”) to model diabetes treatment and weight loss effects of DehydraTECH™-processed glucagon-like peptide 1 (“ GLP-1 ”) drugs and DehydraTECH-processed cannabidiol (“ CBD ”), alone and in combination in diabetic preconditioned rats. What’s New There are several important new areas of investigation to be explored within this broad study. Are DehydraTECH-processed oral GLP-1 drugs more effective than non DehydraTECH-processed oral GLP-1 drugs in: Reaching brain tissue? Improving weight loss? Improving control of blood sugar? Combining with CBD for improved results? One arm of this 12-arm study will, for the first time, evaluate DehydraTECH-processed pure semaglutide and compare it to re-formulated Rybelsus® processed with DehydraTECH, containing Novo Nordisk’s SNAC® ( salcaprozate sodium ) technology. Another arm will, also for the first time, evaluate DehydraTECH-processed liraglutide. Liraglutide is a GLP-1 drug marketed in injectable form by Novo Nordisk under the brand names Victoza® and Saxenda®. Animals in each of the first 8 study arms are being dosed with the following: 1 pure liraglutide DehydraTECH composition; 1 pure semaglutide DehydraTECH composition; 2 reformulated Ryblesus® DehydraTECH compositions; and 4 different DehydraTECH-CBD compositions Study arms 9 through 12 will begin when the first 8 study arms have completed. Based on the results of the initial 8 study arms, study arms 9 and 10 will each utilize the best-performing DehydraTECH-CBD composition with the DehydraTECH-liraglutide composition, and separately, the best performing DehydraTECH-semaglutide composition. Study arms 11 and 12 are placebo and positive control arms. About the Study Each arm of the Study will be dosed for a 12-week period following an acclimation period. During the Study, over 1,500 blood plasma samples will be collected from the total rat population of 72 animals for purposes of detailed pharmacokinetic drug delivery analyses. Body weight and blood glucose readings will be taken prior to Study start and at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. Lexaria will be collecting and reporting interim results prior to the end of the Study. Why Does Brain Absorption Matter? In previous animal research with two other molecules, including CBD, Lexaria demonstrated through brain tissue examination that DehydraTECH processing enabled higher levels of drug delivery into brain tissue. Study WEIGHT-A24-1 is designed to further validate whether DehydraTECH processing can similarly deliver higher quantities of GLP-1 drugs into brain tissue. Recent research has indicated “ that a small peptide GLP-1R agonist penetrates the brain and activates a subset of GLP-1R–expressing neurons in the arcuate nucleus to produce weight loss.” Lexaria believes that, if it can evidence that DehydraTECH processing of GLP-1 drugs can enable greater penetration into brain tissue, then this may help to explain how the GLP-1 drug(s) powered by DehydraTECH may be more effective at enhancing beneficial outcomes such as weight loss and blood sugar control. In turn, this could also potentially allow for lower dosing and a concomitant reduction in adverse side effects. About Lexaria Bioscience Corp. & DehydraTECH DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 41 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com. CAUTION REGARDING FORWARD-LOOKING STATEMENTS 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 are not limited to, statements by the company relating the Company’s ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company’s ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria’s postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated 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 contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. INVESTOR CONTACT: George Jurcic - Head of Investor Relations ir@lexariabioscience.com Phone: 250-765-6424, ext 202
May 17, 2024 09:10 AM Eastern Daylight Time
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