Lexaria Begins Dosing of Its Second GLP-1 Human Pilot Study
Lexaria Bioscience Corp. has commenced its second GLP-1 human pilot study, comparing different formulations of semaglutide for improved drug delivery. The study aims to test the effectiveness of DehydraTECH technology in enhancing oral absorption rates of GLP-1 drugs. The company has successfully completed the first dosing visit for all nine participants and expects the study to conclude by mid-June.
Lexaria Bioscience Corp. is advancing in drug delivery technology through its second GLP-1 human pilot study, showcasing its commitment to innovation in the pharmaceutical industry.
The company has demonstrated superior pharmacokinetic oral delivery performance in a previous study, indicating potential for success in the current study with DehydraTECH-enhanced semaglutide.
There is a risk involved in the study due to the need to investigate systemic absorption in sublingual/buccal tissues, potentially leading to unforeseen side effects or challenges in drug delivery.
The acidic environment of the stomach degrading GLP-1 drugs when swallowed highlights the importance of finding effective absorption technologies, which could pose challenges in the current study.
KELOWNA, BC / ACCESSWIRE / May 8, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that human pilot study #2, GLP-1-H24-2, (the "Study") is underway and the first dosing visit for all nine study participants has already concluded.
The Study is a three-arm, crossover investigation that will compare three 7 mg semaglutide dose formulations:
a positive control Rybelsus® swallowed tablet (already dosed);
DehydraTECH-semaglutide swallowed capsules;
and for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
The second 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 ("FDA IID"), delivered within swallowed capsules. The dosing interval for this Study arm is currently anticipated to complete during mid-June, after the necessary wash-out period for the study participants from the first Study arm.
The acidic environment of the stomach seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than
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 similar in some ways to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles will be compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and a standardized meal will be fed to the test subjects at a point in time after dosing. Nine healthy subjects are expected to be dosed with each test article with roughly a 30-day "washout" interval between each dosing visit.
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 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
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
FAQ
What is Lexaria Bioscience Corp. working on?
How many participants are involved in the study?
What technology is being used to enhance absorption rates of GLP-1 drugs?
When is the study expected to conclude?
