All three dosing arms have been completed.
KELOWNA, BC / ACCESSWIRE / July 9, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX & LEXXW) (the "Company" or "Lexaria"), a global innovator in drug 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 investigation comparing three 7 mg semaglutide dose formulations:
a positive control Rybelsus® swallowed tablet;
DehydraTECH-semaglutide swallowed capsules; and
for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
The final DehydraTECH Study arm used a Rybelsus® composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database ("FDA IID"), delivered within an in-mouth dissolvable tablet. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically through the sublingual/buccal tissues of the mouth and 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 acidic environment of the stomach that seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than 1% when an absorption technology is not used.
All blood samples collected during the study are now being transported to the bioanalytical lab for analysis. We anticipate completing the analysis and announcing the Study results in late August or early September. Next steps include our evaluation and optimization of different semaglutide formulations in our already-underway animal study, as well as evaluation of semaglutide in our upcoming 12-week chronic human study.
"Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the Study on schedule," said Chris Bunka, Chief Executive Officer of the Company. "The results of this Study are expected to validate our earlier work with semaglutide, and also to discover whether it is possible to achieve any absorption of this market-leading GLP-1 drug through the tissues of the mouth."
In the previously announced human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic ("PK") oral delivery performance of the DehydraTECH-enhanced GLP-1 drug semaglutide available commercially in the branded product Rybelsus®.
About the Study
Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.
About Semaglutide
Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.
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 46 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
SOURCE: Lexaria Bioscience Corp.
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