LEXXW - Lexaria Awards Contract For Third GLP-1 Human Pilot Study
(TheNewswire)
First-ever DehydraTECH-processedtirzepatide from Zepbound® to be tested in a swallowed oralformat
Kelowna, British Columbia – May 23,2024 – TheNewswire – Lexaria Bioscience Corp. (Nasdaq: LEXX, LEXXW)(the “Company” or “Lexaria”), a global innovator in drugdelivery platforms announces it has hired acontract research organization (“ CRO ”) to performthe Company’s human pilot study #3, (the “ Study ”) which willevaluate a dual action GLP-1 (glucagon-like peptide) + GIP( glucose-dependent insulintropicpeptide) .
The Study will be a randomized, crossover investigationthat will compare injected tirzepatide (Zepbound® by Eli Lilly) to acompound formulated, DehydraTECH-processed tirzepatide derived fromZepbound® and rendered into a capsule to be swallowed. There are twostudy arms:
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DehydraTECH-tirzepatide swallowed capsules;and,
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Injected Zepbound® tirzepatide by Eli Lilly.
Tirzepatide is currently available only in its injectedform, Zepbound®, by Eli Lilly – it is not available in anFDA-approved oral dosage format. The Study will evaluate whetherDehydraTECH-processed tirzepatide, when taken orally, offers anyabsorption into the human bloodstream and, if so, how much. Humantolerability, pharmacokinetics and blood sugar levels will all berecorded and evaluated in this Study.
“Many GLP-1 drugs have produced unpleasant sideeffects, especially when dosed through oral tablets,” said ChrisBunka, CEO of Lexaria Bioscience Corp. “Lexaria’s latest study inan oral capsule hopes to evidence improved tolerability while alsoproducing measurable quantities of drug in blood. This will beLexaria’s first-ever work with the tirzepatide molecule and, assuch, any noteworthy delivery of tirzepatide through oral deliverycould be a significant finding.”
Manufacturing of the test articles for this Study isanticipated to be completed within 30 days. Independent Review Board(“ IRB ”) approval is required before the Study can commence, andthe Company will provide our next update when IRB approval has beenreceived.
About the Study
Many design characteristics of the Study, also referredto as Study GLP-1-H24-3, are similar to Lexaria’s initial GLP-1 human pilotstudy . The DehydraTECH-tirzepatidetest articles will be compound formulated using Zepbound®, strictlyfor research purposes. The Study is designed to measure tolerabilityand side effects, blood levels of tirzepatide, and blood glucoselevels. Blood samples will be taken multiple times during the first 10hours post dosing; a final blood draw will be taken 24 hours afterdosing; and, a standardized meal will be fed to the test subjects at apoint in time after dosing. Eight healthysubjects are expected to be dosed with each test article following across over study design across two study visits.
About Lexaria Bioscience Corp. &DehydraTECH
DehydraTECH™ is Lexaria’s patented drug deliveryformulation and processing platform technology which improves the wayactive pharmaceutical ingredients (APIs) enter the bloodstream throughoral delivery. Since 2016, Lexaria has developed and investigatedDehydraTECH with a variety of beneficial molecules in oral and topicalformats. DehydraTECH has repeatedly demonstrated the ability toincrease bio-absorption and has also evidenced an ability to deliversome drugs more effectively across the blood brain barrier, whichLexaria believes to be of particular importance for centrally activecompounds. Lexaria operates a licensed in-house research laboratoryand holds a robust intellectual property portfolio with 43 patentsgranted and many patents pending worldwide. For more information,please visit www.lexariabioscience.com .
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