Human Pilot Study #2 (GLP-1-H24-2) Approved
KELOWNA, BC / ACCESSWIRE / April 16, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces approval has been received from an independent third-party ethics review board, for human pilot study #2 (the "Study"), investigating GLP-1 drugs and DehydraTECH.
Subject recruitment will begin immediately and the Company will announce as soon as the first dosing has begun, expected within 30 days or less. The Company anticipates completing the Study this summer.
The Study will be performed in up to 9 healthy volunteers and will study a single 7 mg dose of Rybelsus® (semaglutide) against two different, concentration-matched 7 mg DehydraTECH-enabled semaglutide formulations from crushed Rybelsus®.
One DehydraTECH Study arm will use 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. This arm will be otherwise similar to the first DehydraTECH GLP-1 human pilot study conducted that evidenced higher delivery of semaglutide into blood with superior blood glucose control and better tolerability than was achieved with Rybelsus®.
The second 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 effectively absorb into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective level of blood absorption.
Tolerability, blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated. The DehydraTECH compositions for this study will be compound-formulated using commercially available Rybelsus® tablets as the semaglutide input material.
"I am excited about this Study; the Lexaria scientific team believes that a dissolvable oral tablet that delivers an effective fraction of semaglutide along with reduced side effects could potentially offer valuable benefits to the pharmaceutical industry that might lead to a higher likelihood of favorable strategic partnering with leading industry players in GLP-1," said Chris Bunka, CEO of Lexaria. "Most GLP-1 drugs sold today are administered by painful and expensive injection devices. More effective and tolerable oral delivery of GLP-1 drugs could be extremely valuable to patients and to industry."
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 41 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.
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