Second study arm dosing is now complete.
KELOWNA, BC / ACCESSWIRE / June 5, 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") continues to make progress and the second round of dosing for all nine study participants is now complete. Lexaria expects to complete the third (final) arm of the Study in early July
The Study is a three-arm, crossover investigation that will compare three 7 mg semaglutide dose formulations:
- a positive control Rybelsus® swallowed tablet (complete);
- DehydraTECH-semaglutide swallowed capsules (also complete); and
- for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet..
The second 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 swallowed capsules.
Lexaria's final DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus®. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically into 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 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.
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 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 43 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
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Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.