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7% Weight Loss in Animals Supports Lexaria’s Next 8-week Animal Study

Monday, 04 March 2024 09:15 AM

Lexaria Bioscience Corp.

KELOWNA, BC / ACCESSWIRE / March 4, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, informs that its wholly-owned and patented DehydraTECH-CBD formulation, when administered to rodents in an 8-week study (DIAB-A22-1), resulted in weight loss of 7% and a reduction of 19.9% (p<0.05) in blood glucose. Lexaria has now signed contracts to begin animal study WEIGHT-A24-1; (the "Study"), which will be a large, multi-week animal study that will substantially progress its further DehydraTECH-GLP-1 and DehydraTECH-CBD weight loss investigations.

Lexaria also recently published results in a human study, wherein a single 7 mg semaglutide dose from Rybelsus® processed with DehydraTECH and administered to humans, was absorbed at a significantly higher level than without DehydraTECH processing; and also managed blood glucose levels more effectively without any blood glucose spiking after eating.

Together, these discoveries strongly support additional investigations, including:

  • determining whether daily dosing of DehydraTECH-GLP-1 might result in sustained higher concentrations of GLP-1 in blood over an extended treatment duration than without DehydraTECH processing; and whether such a higher blood concentration might result in greater weight loss over time, and
  • determining whether DehydraTECH-CBD, specially formulated for diabetes control and weight loss, alone and/or in conjunction with DehydraTECH-GLP-1, might also result in greater weight loss and/or blood glucose control over time.

Manufacturing of the test articles for 8 of the 12 arms of the new animal Study has already been completed, and dosing in those arms will commence as soon as the third-party laboratory is able to do so, expected to begin within 45 days. Four different DehydraTECH-CBD compositions will be tested, as well as 4 different DehydraTECH-GLP-1 compositions (comprised of 3 different DehydraTECH-semaglatide formulas and a single, first ever DehydraTECH-liraglutide composition). The comprehensive Study will also test 1 DehydraTECH-CBD composition combined with DehydraTECH-semaglutide; and 1 DehydraTECH-CBD composition combined with the DehydraTECH-liraglutide composition.

More detailed Study information will be released soon about study WEIGHT-A24-1 in separate news.

THE MARKET OPPORTUNITY

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.

GLP-1 drugs have recently been approved by the FDA for type two diabetes and weight loss management. Weight loss of between 10 pounds to 33 pounds, or more, has been widely reported. One 68-week study of 667 people reported an average loss of 15% of body weight.

Because GLP-1 drugs have experienced FDA approvals as recently as 2021 and 2022, and because the health benefits of this drug class are still being discovered and understood, the potential market size is unknown. Published reports are widely estimating $100 billion in sales per year, by 2030. At least one analyst from Guggenheim Partners published a note on September 12, 2023 in which he explained how "the total addressable market for these so-called incretin drugs could balloon to $150 billion to $200 billion."

Diabetes is a disease whereby the body does not produce sufficient insulin, leading to higher than normal levels of sugars in the blood. Risks of kidney disease, vision loss, heart and cardiovascular disease and more are greatly enhanced by individuals with diabetes. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world.

People with type-2 diabetes can often control the disease through lifestyle changes and/or taking certain diabetes medications, whereas those with type-1 diabetes are required to add insulin to their body through syringes, insulin pumps, or other similar devices. Thus, the treatment of diabetes includes devices, drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in 2021. The global diabetes drug market is estimated at $63.1 billion in 2021. Due to the pain and unpleasantness of injections, many diabetes sufferers prefer to treat their condition with drugs rather than devices, if they have the choice. More than 1.9 billion people were overweight in 2016, and due to the growth in obesity, which has nearly tripled from 1975 to 2016, the number of people experiencing diabetes continues to grow.

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
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

Topic:
Company Update
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