Lexaria Awards CRO Contract for 12-Week DehydraTECH GLP-1 Chronic Human Study
Lexaria Bioscience has awarded a contract research organization (CRO) to oversee a 12-week chronic human study, GLP-1-H24-4, evaluating DehydraTECH-GLP-1 formulations for weight loss and blood sugar reduction.
The study, the company’s most comprehensive GLP-1 investigation, will involve clinical sites in Australia and comply with Australian regulatory standards. Upon completion, it aims to gain recognition as a Phase 1b study by the U.S. FDA. Study preparations with the CRO include clinical protocol design, regulatory submissions, and data management planning.
- Lexaria hired a CRO to execute a 12-week GLP-1 human study.
- The study focuses on weight loss and blood sugar reduction.
- Study preparations include full clinical protocol design and regulatory submissions.
- Study aims to be recognized as a Phase 1b registrational study by the FDA.
- The study is the most comprehensive GLP-1 investigation by Lexaria.
- The study's success heavily depends on regulatory approvals and data management efficacy.
- There is inherent risk in clinical study outcomes affecting stock performance.
- The extended treatment duration could lead to higher expenses.
- Potential delays in the study could affect investor confidence and stock prices.
Lexaria's decision to initiate a 12-week chronic human study on DehydraTECH-GLP-1 formulations is significant due to the potential implications for weight loss and blood sugar reduction. GLP-1 (glucagon-like peptide-1) is a hormone that plays a critical role in regulating insulin secretion and appetite. This study aims to explore DehydraTECH's ability to enhance the efficacy and tolerability of GLP-1 therapies, which could be a game-changer in managing obesity and type 2 diabetes.
The involvement of multiple clinical investigational sites in Australia and the classification of the study as a Phase 1b registrational study by both Australian and U.S. authorities add credibility. The extended treatment duration will provide a robust dataset, making the findings more reliable and comprehensive. If successful, this could lead to broader acceptance and potentially faster regulatory approval.
For investors, this study represents a key milestone. Positive results could significantly enhance Lexaria's market position and open new revenue streams through licensing or partnerships. However, clinical trials are inherently risky and there is always the possibility that results may not meet expectations.
The financial implications of this study are multifaceted. Firstly, the engagement of a contract research organization (CRO) indicates a substantial investment in the development and validation of DehydraTECH-GLP-1 formulations. This signals Lexaria's commitment to advancing its drug delivery platforms, which could enhance shareholder value if the study yields positive results.
The study's classification as a Phase 1b registrational study by both Australian and U.S. regulatory authorities is noteworthy. Successful completion could expedite the path to market, reducing overall development costs and timelines. Lexaria may also attract strategic partnerships or licensing deals, providing additional revenue streams and bolstering its financial position.
However, investors should be cautious of the inherent risks associated with clinical trials. Substantial funds are allocated to these studies and negative outcomes could adversely affect the company's valuation. It's also essential to consider the competitive landscape in GLP-1 therapies, where several major pharmaceutical companies have established footholds.
Weight Loss and Blood Sugar Reduction are Major Efficacy Objectives
KELOWNA, BC / ACCESSWIRE / June 18, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX,)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has now hired a contract research organization ("CRO") to oversee execution of the Company's 12-week chronic study GLP-1-H24-4, (the "Study") which will evaluate various DehydraTECH-GLP-1 (glucagon-like peptide) formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Study preparations with the CRO have commenced pursuant to an initial start-up agreement under which a number of activities will occur such as full clinical protocol design and writing in consultation with medical experts, regulatory authority submissions, and data management planning.
"This Study will be the most comprehensive and impactful GLP-1 investigation that Lexaria has ever undertaken," said John Docherty, President of Lexaria Bioscience Corp. "The greatly expanded scope compared to our previous studies will allow us to investigate DehydraTECH-GLP-1 safety and efficacy over an extended treatment duration to significantly broaden our knowledge of DehydraTECH's ability to potentially improve the effectiveness and tolerability of this world-leading class of drugs."
The Study will be conducted using a number of clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. Upon completion, the Study is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").
About The Study
The currently-planned design of the Study has been expanded to include five active treatment arms, each with 16 diabetic patients (80 patients in total), with each patient dosed orally daily, subject to change once the final protocol is complete.
- Rybelsus® as positive control;
- DehydraTECH-cannabidiol ("CBD");
- DehydraTECH-semaglutide;
- DehydraTECH-CBD combined with DehydraTECH-semaglutide; and,
- DehydraTECH-tirzepatide.
An important component of this Study will be the fact that Lexaria intends to test DehydraTECH-GLP-1 formulations prepared using pure GLP-1 drug substances such as semaglutide and the dual action GLP-1 / GIP (glucose-dependent insulinotropic peptide) agonist tirzepatide without the need to create compound formulations using the corresponding commercially approved products Rybelsus® and Zepbound® respectively to render the DehydraTECH versions to be studied. As such, this Study will allow DehydraTECH safety and efficacy to be tested without the Rybelsus® enabling ingredient salcaprozate sodium ("SNAC"), with the ability to demonstrate DehydraTECH effectiveness alone.
Lexaria reminds its followers that our 2022 diabetes study DIAB-A22-1, utilizing a never-before-used formulation variant of DehydraTECH-CBD, evidenced weight loss of
In its first-ever GLP-1 study in humans reported in January, 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® itself. Lexaria is anxious to discover whether this improved pharmacokinetic performance might lead to improved weight loss and/or blood-sugar control compared to Rybelsus® alone after multi-week dosing.
The Company will provide further updates when the manufacturing of all clinical test articles; the Research Ethics Committee review; and the Australian Therapeutic Goods Administration notification have each been completed. Once protocol development and these milestones have been achieved, the Company will be able to more accurately estimate dates for first patient dosing and for Study completion.
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.
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
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