Lexaria's GLP-1 Human Pilot Study #3 Begins Dosing
DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format
KELOWNA, BC / ACCESSWIRE / October 9, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has begun, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) Zepbound® (tirzepatide) in an oral dose format.
The Study is being conducted in up to 10 healthy volunteers. The initial seven day dosing phase of either an oral DehydraTECH-processed tirzepatide capsule or a single injected tirzepatide dose is scheduled to be completed on October 13th. After a multi-week washout period, the second (final) seven day dosing phase will be administered in mid-November where subjects will receive the alternate treatment condition than what was received during the initial dosing phase. No serious adverse events have been observed thus far during this initial dosing phase.
Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated in this Study. The DehydraTECH compositions for this Study were compound-formulated using commercially available Zepbound® injectable formulation as the tirzepatide input material.
Tirzepatide is currently approved for use in the USA under the brand names Zepbound® and Mounjaro®, owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024.
In two previous human pilot studies, Lexaria has evidenced that processing of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) with DehydraTECH and administered in an oral format, shows improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to the Rybelsus® tablet. The two drugs, semaglutide and tirzepatide are believed to comprise over 90% of all revenue generated in the GLP-1 sector today.
In pilot Study #3 referred to today, Lexaria is hopeful of evidencing meaningful absorption rates of tirzepatide in a swallowed oral format, which is not available in the market today since it is currently administered only by injection.
About the Study
Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide to be administered orally daily for seven days. The Zepbound® formulation has a strength of 2.5 mg tirzepatide to be administered once via injection with the subject monitored over the same seven day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples will be taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with a final blood draw taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Single blood samples will also be taken daily on each of the second through eighth days following commencement of dosing. Up to ten healthy subjects are expected to be dosed with each test article following a randomized, cross over study design across two study phases.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. 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.
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SOURCE: Lexaria Bioscience Corp.
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