Pursuing the world's first-ever orally-dosed liraglutide
KELOWNA, BC / ACCESS Newswire / February 20, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that it has made a strategic business decision to further investigate the commercial opportunities and applications for a unique new GLP-1 solution: orally taken liraglutide processed with our wholly-owned DehydraTECH™ enhancement technology.
"Our ability to work with liraglutide, which went off-patent last year, is an opportunity that does not often present itself," said Rich Christopher, CEO of Lexaria. "Lexaria has already demonstrated that our unique DehydraTECH technology seems to deliver potent oral delivery performance characteristics to liraglutide. This opens the door to the possibility of Lexaria developing and selling the world's first oral capsule or tablet version of liraglutide."
As part of that strategic business decision, Lexaria has already filed certain patent applications related to DehydraTECH-enhanced oral liraglutide which, if granted, will further support Lexaria's ability to commercialize oral DehydraTECH-liraglutide. Presently, there is no oral version of liraglutide available commercially anywhere in the world and Lexaria is hopeful that potential new patent awards in this sector could be of strategic value to the Company.
Lexaria's patent applications are reinforced by the successful animal study results announced on November 20, 2024 that evidenced superior pharmacodynamic ("PD") performance. In that study, DehydraTECH-liraglutide outperformed the Rybelsus® control group by week 12 both in terms of blood sugar and body weight control, by 11.53% (p<0.0001) and 11.13% (p=0.0395) respectively.
Those positive study results reinforced Lexaria's diversified strategy to conduct work, all at the same time, on all three of the world's leading GLP-1/GIP weight-loss/diabetes drugs: liraglutide, semaglutide, and tirzepatide. Estimated global 2024 revenue of these three drugs is~$30 billion, compared to just $300 million in 2018, an increase of 100x or 10,000%.
To support the broader strategy of entering the GLP-1 weight loss and diabetes control market as quickly as possible, Lexaria is also preparing to commence pilot clinical testing of DehydraTECH-liraglutide in humans, as announced on January 15, 2025, when we received the necessary independent ethics board approval that allowed our contract research organization to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). That Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® to the conventional injected liraglutide (Saxenda®).
If that Study is successful, Lexaria intends to begin additional registrational clinical testing to demonstrate wider safety and PD performance utilizing orally-dosed DehydraTECH-liraglutide. Positive results could then be used as part of a potentially accelerated regulatory approval pathway with the Food and Drug Administration to seek approval to launch the world's first orally-dosed liraglutide, ideally with the approval of liraglutide's developer, Novo Nordisk®.
Liraglutide is currently sold only in an injectable form under the brand names Saxenda® and Victoza®, both manufactured by Novo Nordisk®. Despite the launch of a genericized injected version of liraglutide by Teva® during 2024, liraglutide sold by Novo Nordisk® under the brand names of Saxenda® still generated US$849 million in the first half of 2024; and generated an additional US$1.6 billion in recent annual revenue under the brand name Victoza®.
About Lexaria Bioscience Corp. & DehydraTECH DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral 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. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 48 patents granted and additional 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
