Dosing Continues in Lexaria’s Second GLP-1 Human Pilot Study
Lexaria Bioscience continues progressing its second GLP-1 human pilot study (GLP-1-H24-2), with the second dosing arm now complete for all nine participants. The study, a three-arm crossover investigation, compares three 7 mg semaglutide dose formulations: a positive control Rybelsus® tablet, DehydraTECH-semaglutide swallowed capsules, and an innovative in-mouth dissolvable DehydraTECH-semaglutide oral tablet. This is the first study to investigate if DehydraTECH-enhanced semaglutide can be absorbed systemically via sublingual/buccal tissues, potentially offering better absorption and fewer side effects than swallowed administration. Lexaria plans to complete the final study arm by early July 2024.
- Completion of second dosing arm for nine participants.
- Three-arm crossover study design aimed at detailed comparative analysis.
- Investigation of innovative in-mouth dissolvable oral tablet formulation for the first time.
- Potential for DehydraTECH-enhanced semaglutide to achieve systemic absorption through sublingual/buccal tissues.
- FDA IID compliance for all DehydraTECH formulations in the study.
- Previous pilot study indicated superior pharmacokinetic performance of DehydraTECH-enhanced GLP-1 drug semaglutide.
- Study results pending for the final dosing arm, introducing uncertainty.
- Potential side effects from DehydraTECH-enhanced semaglutide not yet fully determined.
Insights
Lexaria Bioscience Corp. is continuing its innovative research on its drug delivery platform, DehydraTECH, with its ongoing human pilot study for semaglutide formulations. The significant aspect here is the comparative nature of the study, examining various formulations for enhanced absorption and efficiency. The company's goal to overcome the challenge of low absorption rates due to the acidic stomach environment could revolutionize the administration of GLP-1 drugs, potentially enhancing patient outcomes.
Pharmacokinetics (PK) is a critical aspect in drug development, referring to how drugs move through the body. Lexaria’s focus on PK performance improvement highlights their attempt to ensure more efficient drug delivery. This could mean fewer required doses and better patient adherence to treatment regimens. If successful, DehydraTECH could be a game-changer for oral drug delivery, offering benefits such as reduced side effects and improved efficacy.
For retail investors, this study signifies potential future value if the technology proves effective. The success of DehydraTECH could lead to partnerships or licensing deals with other pharmaceutical companies, increasing Lexaria's revenue streams. However, the outcome of the study is yet uncertain and the timeline for any significant market impact could be long-term.
From a financial perspective, Lexaria’s continued progress in their pilot study showcases their commitment to developing their DehydraTECH platform. Successful results could translate to significant revenue opportunities, including potential collaborations and licensing agreements with larger pharmaceutical companies. The mention of FDA IID compliance is critical, indicating that Lexaria is taking the necessary regulatory steps to ensure their product meets stringent standards, potentially smoothing the path to market approval and commercialization.
However, investors should be cautious as clinical trials are inherently risky and expensive. The completion of the third arm in early July will be a critical milestone. Positive results could lead to a notable uptick in stock price, but delays or negative outcomes could have adverse effects.
In the short term, stock volatility may be expected as trial results are released. In the long term, successful studies could lead to exponential growth and sustained revenue streams.
Second study arm dosing is now complete.
KELOWNA, BC / ACCESSWIRE / June 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that human pilot study #2, GLP-1-H24-2, (the "Study") continues to make progress and the second round of dosing for all nine study participants is now complete. Lexaria expects to complete the third (final) arm of the Study in early July
The Study is a three-arm, crossover investigation that will compare three 7 mg semaglutide dose formulations:
- a positive control Rybelsus® swallowed tablet (complete);
- DehydraTECH-semaglutide swallowed capsules (also complete); and
- for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet..
The second DehydraTECH Study arm used a Rybelsus® composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database ("FDA IID"), delivered within swallowed capsules.
Lexaria's final DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus®. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective drug delivery into the bloodstream. This is because of the acidic environment of the stomach that seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than
In the previously announced human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic ("PK") oral delivery performance of the DehydraTECH-enhanced GLP-1 drug semaglutide available commercially in the branded product Rybelsus®.
About the Study
Design characteristics of the Study are comparable to 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. Nine healthy subjects are expected to be dosed with each test article with roughly a 30-day "washout" interval between each dosing visit.
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 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 progress has Lexaria Bioscience made in its second GLP-1 human pilot study?
What is the focus of Lexaria's second GLP-1 human pilot study?
What is unique about Lexaria's DehydraTECH-semaglutide oral tablet formulation?
When does Lexaria expect to complete the final dosing arm of the study?
What were the results of Lexaria's previous pilot study concerning DehydraTECH-enhanced semaglutide?
