Lexaria Awards Contract For Next GLP-1 Human Pilot Study
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Insights
The commencement of a human pilot study by Lexaria Bioscience Corp to test a novel dissolvable DehydraTECH-GLP-1 oral dose formulation represents a significant step in the field of drug delivery systems, particularly for diabetes treatment. GLP-1 agonists like semaglutide have been transformative in managing type 2 diabetes and obesity, but their administration often requires injections, which can be a barrier for some patients.
Current oral formulations like Rybelsus® have absorption challenges, with less than 1% efficiency when swallowed. Lexaria's technology aims to circumvent the harsh gastric environment by enhancing buccal/sublingual absorption. If successful, this could substantially increase patient adherence and improve therapeutic outcomes, potentially disrupting the current market for GLP-1 therapies. The long-term implications could include wider use of oral semaglutide, pressure on competitors to innovate and substantial market growth for Lexaria if patented technologies are licensed.
The pilot study's success could have a pronounced effect on the pharmaceutical market, particularly within the diabetes care segment. Oral delivery of GLP-1 therapies is a growing area of interest, given the convenience and preference over injectables. Should Lexaria's dissolvable tablet demonstrate superior absorption rates and patient experience, it could capture significant market share and attract partnership opportunities with larger pharmaceutical companies.
Investors should monitor the study's progress and subsequent data releases, as positive results could lead to a reevaluation of Lexaria's market position and potential revenue streams. However, it's important to consider the regulatory hurdles and the time required to bring such a product to market. The immediate stock market reaction might be tempered by the understanding that commercialization is still a distant milestone, albeit one with substantial implications.
Lexaria's investment in this second human pilot study represents a strategic allocation of resources towards a potentially high-return innovation. The biotechnology sector is driven by such advancements and successful clinical outcomes can lead to significant stock valuation increases. However, the costs associated with R&D in this space are substantial and the timeline to profitability can be lengthy, necessitating careful financial planning.
With Lexaria's update on the manufacturing timeline and the need for Independent Review Board approval, investors are provided with a clear roadmap of the study's progression. The correction of the animal study's duration from 8 to 12 weeks is a minor but important clarification for those tracking the company's research timelines and potential impact on the stock's liquidity and volatility in the short term.
- First-ever dissolvable DehydraTECH-GLP-1 oral dose formulation to be tested
- Rybelsus® semaglutide will act as the positive control
KELOWNA, BC / ACCESSWIRE / March 7, 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 second DehydraTECH-powered glucagon-like peptide 1 ("GLP-1") human pilot study #2 (the "Study").
The Study will be a randomized, crossover, placebo-controlled investigation that will compare three dose formulations each at a 7 mg semaglutide dose:
- a positive control Rybelsus® swallowed tablet;
- DehydraTECH-semaglutide swallowed capsules; and,
- for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
Semaglutide swallowed into the stomach/intestine absorbs into the bloodstream at an exceptionally low rate typically at less than
"DehydraTECH has previously shown an ability to improve delivery of certain drugs destined for the bloodstream, through the buccal/sublingual tissues of the mouth and throat," said Chris Bunka, CEO of Lexaria Bioscience Corp. "If this new Study is successful in demonstrating efficacy and safety, the potential for a new era in GLP-1 delivery without the need for painful injections or stomach-upsetting tablets, could be within reach."
Manufacturing of the test articles for this Study is anticipated to be completed within 30 days. Independent Review Board approval is required before the Study can commence, and the Company will provide our next update when dosing has begun.
CORRECTION
In Lexaria's press release of March 4, we described an upcoming animal study as having an 8-week duration. That was a typographical error: the correct animal study duration is 12-weeks.
About the Study
Many design characteristics of the Study will be fundamentally the same as in Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles will be compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, 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 three study visits.
About Semaglutide
Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.
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 39 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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