- Multiple DehydraTECH-GLP-1 and DehydraTECH-CBD formulations to be tested
- Chronic dosing over a 12-week treatment period
- Will assess weight loss and blood glucose level control
- Efficacy through possible brain absorption delivery enhancement to be assessed
KELOWNA, BC / ACCESSWIRE / March 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces details of an 8-week animal study WEIGHT-A24-1 (the "Study") to examine diabetes and weight loss effects of DehydraTECH-processed glucagon-like peptide 1 ("GLP-1") drugs and DehydraTECH-processed cannabidiol, alone and in combination.
The contract for the Study has been awarded to a third-party, Health Canada-licensed Canadian research laboratory. Manufacturing of the compositions for the first 8 of the 12 arms of the Study has already been completed, and those arms will commence as soon as the testing laboratory is able to do so, expected to begin within 45 days.
Detailed information of the 12 Study arms is as noted:
- Group 1: DehydraTECH-CBD (composition "A")
- Group 2: DehydraTECH-CBD (composition "B")
- Group 3: DehydraTECH-CBD (composition "C")
- Group 4: DehydraTECH-CBD (composition "D")
- Group 5: DehydraTECH-GLP-1 (re-formulated Rybelsus® "E")
- Group 6: DehydraTECH-GLP-1 (re-formulated Rybelsus® "F")
- Group 7: DehydraTECH-GLP-1 (pure semaglutide "G")
- Group 8: DehydraTECH-GLP-1 (pure liraglutide "H")
- Group 9: Combination of one of E, F, or G and one of A, B, C, or D (TBD)
- Group 10: Combination of H and one of A, B, C, or D (TBD)
- Group 11: Vehicle (placebo) arm
- Group 12: Positive control arm
Each arm of the Study will be dosed for an 8-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. LC-MS/MS and other techniques will be used to analyse samples. Also, the Study will allow examination of DehydraTECH-processed semaglutide with and without the salcaprozate sodium "SNAC" technology currently found within Rybelsus® tablets. We will be collecting and reporting interim results prior to the end of the Study.
Study arms 9 and 10 will have a later start-date due to some information outputs required from the other Study arms before they and study arms 11 and 12 can commence. The Company will provide an update when animal dosing has begun.
In previous animal research with two other molecules, including cannabidiol, Lexaria demonstrated through brain tissue examination that DehydraTECH processing can enable higher levels of drug delivery across the blood-brain-barrier and directly into brain tissue. It is unknown, today, whether DehydraTECH processing can deliver higher quantities of GLP-1 drugs into brain tissue, and Study WEIGHT-A24-1 is designed to answer that question in animals.
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 39 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
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.