Lexaria Awards Contract For Third GLP-1 Human Pilot Study
Lexaria Bioscience has awarded a contract for its third human pilot study to a contract research organization. This study will evaluate the dual action glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) using a DehydraTECH-processed tirzepatide in an oral capsule format versus the injected tirzepatide (Zepbound® by Eli Lilly). The study aims to determine the absorption, human tolerability, and blood sugar level effects of the oral DehydraTECH-processed tirzepatide. This marks the first study of its kind for Lexaria, potentially paving the way for an FDA-approved oral dosage format of tirzepatide. Manufacturing for the study's test articles is expected to complete within 30 days, pending Independent Review Board approval.
- New pilot study to explore oral dosage format for tirzepatide, potentially improving patient convenience and compliance.
- Contract awarded to a CRO, ensuring professional and systematic study execution.
- Study will evaluate dual-action GLP-1 and GIP, potentially enhancing therapeutic benefits.
- Potentially significant finding if oral delivery of tirzepatide is successful.
- Manufacturing of test articles expected to complete within 30 days, indicating swift progress.
- Study requires Independent Review Board approval before commencement, presenting a possible delay.
- No current FDA-approved oral dosage format for tirzepatide, indicating unproven efficacy and safety in this format.
- Possible unpleasant side effects historically associated with oral GLP-1 drugs.
- Uncertainty in the absorption and pharmacokinetics of the oral DehydraTECH-processed tirzepatide.
Insights
Lexaria's third human pilot study focuses on testing their DehydraTECH technology in combination with Eli Lilly's tirzepatide. The potential significance lies in the novel oral delivery format for a drug traditionally administered via injection.
The key aspect of this study is to determine the efficacy of oral absorption of tirzepatide when processed with DehydraTECH. If successful, this could indicate a major advancement in drug delivery technology. Generally, GLP-1 drugs like tirzepatide are known to cause side effects, particularly when taken orally. Lexaria's approach aims to mitigate these issues, potentially improving patient compliance and comfort.
Furthermore, the study’s design as a randomized, crossover investigation helps ensure the robustness of the results. By comparing the injected formulation directly with the DehydraTECH-processed oral version, the results can provide clear insights into the relative performance of these administration methods. If the study shows significant absorption and improved tolerability, it could open new avenues for non-invasive drug delivery methods, making treatments more accessible and pleasant for patients.
However, the critical factor remains whether the DehydraTECH technology can indeed enhance the oral bioavailability of tirzepatide to a clinically relevant level. This study could potentially disrupt the current market if successful, but it's important to remain cautious until definitive results are available.
The study’s outcome will be pivotal in determining the future applications of Lexaria's technology in the pharmaceutical field.
From a financial perspective, Lexaria's pilot study represents a significant step towards showcasing the commercial viability of their DehydraTECH technology. The current market for GLP-1 receptor agonists, including tirzepatide, is substantial, with Eli Lilly's Zepbound® being a key player. If Lexaria can demonstrate effective oral delivery through their technology, it could position them as a partner of choice for pharmaceutical companies looking to enhance their product offerings.
This could potentially lead to licensing agreements or collaborations, driving revenue growth and increasing the company's market valuation. However, the immediate financial impact of this announcement is limited, as the study is still in its early stages and results are not yet available.
Investors should also consider the risks involved. Drug development is inherently uncertain and even promising technologies can face setbacks. The need for Independent Review Board (IRB) approval and subsequent trial phases adds layers of complexity and potential delays. Moreover, the outcome of this study will determine future funding requirements and project timelines.
In the short term, the news may generate interest and speculation in Lexaria's stock, but the long-term financial benefits will hinge on successful study outcomes and subsequent steps towards commercialization.
First-ever DehydraTECH-processed tirzepatide from Zepbound® to be tested in a swallowed oral format
KELOWNA, BC / ACCESSWIRE / May 23, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has hired a contract research organization ("CRO") to perform the Company's human pilot study #3, (the "Study") which will evaluate a dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulintropic peptide).
The Study will be a randomized, crossover investigation that will compare injected tirzepatide (Zepbound® by Eli Lilly) to a compound formulated, DehydraTECH-processed tirzepatide derived from Zepbound® and rendered into a capsule to be swallowed. There are two study arms:
- DehydraTECH-tirzepatide swallowed capsules; and,
- Injected Zepbound® tirzepatide by Eli Lilly.
Tirzepatide is currently available only in its injected form, Zepbound®, by Eli Lilly - it is not available in an FDA-approved oral dosage format. The Study will evaluate whether DehydraTECH-processed tirzepatide, when taken orally, offers any absorption into the human bloodstream and, if so, how much. Human tolerability, pharmacokinetics and blood sugar levels will all be recorded and evaluated in this Study.
"Many GLP-1 drugs have produced unpleasant side effects, especially when dosed through oral tablets," said Chris Bunka, CEO of Lexaria Bioscience Corp. "Lexaria's latest study in an oral capsule hopes to evidence improved tolerability while also producing measurable quantities of drug in blood. This will be Lexaria's first-ever work with the tirzepatide molecule and, as such, any noteworthy delivery of tirzepatide through oral delivery could be a significant finding."
Manufacturing of the test articles for this Study is anticipated to be completed within 30 days. Independent Review Board ("IRB") approval is required before the Study can commence, and the Company will provide our next update when IRB approval has been received.
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. The DehydraTECH-tirzepatide test articles will be compound formulated using Zepbound®, strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, 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. Eight healthy subjects are expected to be dosed with each test article following a cross over study design across two study visits.
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
What is the focus of Lexaria's third human pilot study announced on May 23, 2024?
What is Lexaria's DehydraTECH technology?
What is unique about the study's DehydraTECH-processed tirzepatide?
When is the manufacturing of the study's test articles expected to complete?
What approval is required before Lexaria's study can commence?
