Lexaria's GLP-1 Human Pilot Study #3 Begins Dosing
Rhea-AI Summary
Lexaria Bioscience Corp. (NASDAQ:LEXX) has initiated dosing for its third human pilot study, investigating an oral dose format of DehydraTECH-processed tirzepatide from Zepbound®. The study involves up to 10 healthy volunteers and consists of two seven-day dosing phases with a multi-week washout period in between. The first phase is set to conclude on October 13, 2024, with the second phase to begin in mid-November. No serious adverse events have been reported. The study will evaluate tolerability, blood absorption levels, and blood sugar control. Tirzepatide, marketed under Zepbound® and Mounjaro® by Eli Lilly™, is expected to generate $15 billion in 2024. Lexaria aims to demonstrate significant absorption rates for oral tirzepatide, building on previous studies showing improved absorption and reduced adverse events for DehydraTECH-processed semaglutide.
Positive
- Initiation of human pilot study #3 for DehydraTECH-processed tirzepatide.
- No serious adverse events reported in the initial dosing phase.
- Evaluation of key metrics: tolerability, blood absorption levels, and blood sugar control.
Negative
- Study to only 10 healthy volunteers.
News Market Reaction
On the day this news was published, LEXX declined 2.78%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
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
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.
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 to 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
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