KELOWNA, BC / ACCESS Newswire / April 23, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following glucagon-like peptide-1 ("GLP-1") strategic update following important industry developments reported both by Pfizer® Inc. and by Eli Lilly and Company®.
Nearly all of the world's top pharmaceutical companies are racing to develop new oral GLP-1 drugs, including: Amgen®, AstraZenca, Eli Lilly, Merck®, Novo Nordisk®, Pfizer®, and Roche®.
By enhancing the performance of oral dosing choices as a replacement for disliked injections; and by reducing adverse events - often the #1 reason that patients stop using GLP-1 drugs - Lexaria's proprietary DehydraTECH technology could be of vital importance to any of these companies in their pursuit of the next oral GLP-1 drug(s).
As previously announced, Lexaria has already demonstrated in human testing, enhanced delivery performance to the world's ONLY existing orally dosed GLP-1 drug: Rybelsus® (semaglutide), owned by Novo Nordisk®.
On April 14, 2025, Pfizer® announced that it would scrap development of danuglipron as a once-daily oral GLP-1 treatment after a patient in a trial experienced a liver injury possibly related to the drug. This was doubly disappointing since, in December 2023, Pfizer® had discontinued a twice-daily trial dose of danuglipron after unwanted side effects derailed an earlier study.
Similarly, Pfizer® experienced earlier setbacks in 2023 with a different GLP-1 drug, lotiglipron, when it too resulted in elevated liver enzymes in patients who took the drug in earlier clinical studies. Development of safe and effective orally-dosed GLP-1 drugs is extremely challenging even for the largest pharmaceutical companies in the world, and Pfizer® and others still need to rise to the challenge of developing effective oral GLP-1 drugs with minimal side effects.
On April 17, 2025, Eli Lilly reported that their experimental, orally-dosed GLP-1 drug (orfoglipron) resulted in lower blood sugar and lower body weight after 40 weeks in a phase 3 clinical trial. As a result of this news, Eli Lilly's market valuation increased by nearly $100 billion in a single day.
Eli Lilly plans to apply for approval to launch the drug for both weight loss and diabetes treatment in 2026 - and that rapid path to market, combined with the fact that it might be only the 2nd oral GLP-1 drug to potentially be approved by the Food and Drug Administration ("FDA"), is likely responsible for the dramatic market response to the news.
Although clearly a positive step forward for the weight loss and diabetes treatment sectors, it should still be noted that 13% to 18% of patients receiving the drug experienced nausea; 19% to 26% experienced diarrhea; and 5% to 14% experienced vomiting. Lexaria's experience with other GLP-1 drugs to date in humans, has shown a trend towards reducing these types of side effects.
Side Effects a Known Challenge.
In the studies just reported (above), and in earlier studies, unwanted side effects remain one of the largest challenges still faced by the industry, seemingly without a solution in sight. The results of another study showed that between 47% and 64% of GLP-1 users with type 2 diabetes discontinued use of their GLP-1 drug within 1 or 2 years, respectively. "Gastrointestinal adverse events were linked to the discontinuation rates."
Obviously, side effects serious enough to persuade patients to discontinue use of an otherwise effective drug, are a major problem for the industry. For companies like Pfizer®, those side effects have been serious enough to stop drug development in its tracks.
As Lexaria reported on August 28, 2024 and January 14, 2025, DehydraTECH-GLP-1 processing has repeatedly shown its propensity to reduce side effects, including but not limited to gastrointestinal adverse events, in both of the major GLP-1 drugs currently available in the world today, being Eli Lilly's tirzepatide, and Novo Nordisk's® semaglutide. One of the only other GLP-1 drugs on the market today, liraglutide, is currently in pilot testing by Lexaria in humans utilizing DehydraTECH processing.
Lexaria is rapidly executing its multi-faceted strategy centered around its proprietary DehydraTECH processing technology. Our main goal is to attract pharmaceutical companies seeking the benefits of adopting Lexaria's technology for use with their own existing drug products. This first prong of our strategy has been evidenced and validated by the Company's entry in a material transfer agreement with a pharmaceutical company ("PharmaCO") which was announced in September of 2024. Lexaria continues to collaborate with PharmaCO on evaluating DehydraTECH compositions.
As we noted on November 26, 2024, GLP-1 drugs are either approved for use, or are being investigated for use, in all of the following healthcare sectors:
Most recently, the FDA approved Ozempic® (semaglutide) owned by Novo Nordisk®, to "reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease ("CKD"). This has the potential to literally be a life-saver for some of the 37 million adults in America struggling with CKD, which, until now, often had NO CURE.
As we noted on November 7, 2024, growth expectations for the GLP-1 industry - prior to the FDA's approval of semaglutide for treatment of CKD - supported a growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and 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 to 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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