DehydraTECH-powered GLP-1 drugs will be evaluated for potential improvements such as:
- Reduced side effects;
- Enhanced weight loss;
- Improved health outcomes for diabetes and other conditions;
- Improved oral bioavailability;
- Reduced cost.
KELOWNA, BC / ACCESSWIRE / September 21, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces its intention to launch new human and animal studies to examine DehydraTECH™-processed glucagon-like peptide-1 ("GLP-1") drugs such as, but not limited to, semaglutide sold under Novo Nordisk's brand names Ozempic®, Wegovy® and Rybelsus®, for purposes of improved bioavailability, cost-effectiveness, tolerability, weight loss potential, management of diabetes and other health conditions.
Through these studies, Lexaria hopes to achieve superior pharmacokinetic ("PK") performance using DehydraTECH-powered GLP-1 drugs which could enable drug delivery via oral capsule at lower costs than current injectables, with reduced side effects and enhanced health benefits.
This is a significant expansion of Lexaria's ongoing and planned diabetes study program to examine its patented DehydraTECH-CBD for diabetes control in humans. The Company now intends to evaluate this alongside and together with DehydraTECH-processed GLP-1 agents. Program design has already commenced, and initial study work will begin as soon as possible.
Lexaria has demonstrated in many previous R&D programs, including five human clinical studies, that DehydraTECH can greatly improve the PK performance of many orally administered drugs into the bloodstream, such as certain antiviral drugs, estradiol, PDE-5 Inhibitors, cannabinoids and more. Like many of these agents, GLP-1 drugs also exhibit low oral bioavailability without the use of absorption enhancement technology, such as Lexaria's DehydraTECH. Lexaria has also previously shown in animal studies that its patented DehydraTECH-CBD lowered body weight over a sustained dosing period by 7%, and also lowered blood sugar and triglyceride levels.
The Company has also demonstrated that specific customized DehydraTECH oral capsule formulations can achieve remarkable improvements in PK performance. For example, the particular DehydraTECH-CBD formulation that was used in its recently completed DIAB-A22-1 diabetes study demonstrated almost a 3-fold improvement in drug delivery into blood than the differentiated DehydraTECH-CBD formulation that was used in Lexaria's HYPER-H21-4 hypertension study that, itself, demonstrated significantly better PK performance and effectiveness than pharmaceutical-grade CBD industry comparators like Epidiolex®.
About GLP-1 Drugs.
GLP-1 drugs have recently been approved by the Food and Drug Administration ("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.
Widely reported anecdotal commentary is also suggesting that some patients are experiencing reduced cravings for alcohol, nicotine and opioids while taking GLP-1 drugs. Other trials are examining their effects on heart disease and even dementia in part because of evidence that GLP-1 drugs may reduce the build-up of the proteins amyloid and tau in the brain, thought to be partly responsible for Alzheimer's disease.
Side effects of the GLP-1 drugs vary but can include nausea, vomiting, diarrhea and more. A small number of GLP-1 drugs have already been approved in oral format but some studies have reported worse side effects with the oral form. The drugs are also being investigated for their relationship to bone density, muscle loss and more. Because of potential serious side effects, it may be beneficial to treat patients with lower oral doses of the drugs, something that Lexaria's DehydraTECH technology may enable if it can improve the PK performance of GLP-1 drugs through oral capsules.
Although the GLP-1 drugs are effective at controlling diabetes and promoting weight loss, they are expensive, and the benefits often reverse if the patient stops taking the drug. Typical non-insured costs of US$900/month or more are common. If DehydraTECH improves the PK performance of oral GLP-1 drugs it could potentially result in cost savings for the patient through lower doses.
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 still 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 in which he explained how "the total addressable market for these so-called incretin drugs could balloon to $150 billion to $200 billion."
About Lexaria's Diabetes Study Program.
Lexaria began its DehydraTECH diabetes-related formal studies in 2022. On March 2, 2023 and June 16, 2023 Lexaria announced that in pre-clinical diabetes study DIAB-A22-1 in obese diabetic-conditioned animals, DehydraTECH-CBD achieved each of the following:
- Lowered blood glucose levels by 19.9% (p<0.05)
- Lowered overall body weight by 7% sustained over 8 weeks
- Increased locomotor activity (p<0.05)
- Lowered triglyceride levels by more than 25% (p<0.007)
- Lowered blood urea nitrogen levels by 27.9% (p<0.001)
On August 2, 2023 Lexaria announced its intention to study weight loss and diabetes control in a human population using DehydraTECH-CBD.
Lexaria's goals within its diabetes study program have significantly expanded and now include the concept of applying DehydraTECH technology, individually, to each of CBD and GLP-1 drug(s), but also to potentially utilize a combination of drugs that includes both a GLP-1 component and DehydraTECH-CBD, together. At this time, no other company in the world is utilizing DehdyraTECH technology relative to GLP-1 drugs.
DehydraTECH-CBD's ability to reduce blood sugar levels in animals is extremely encouraging and warrants additional investigation. According to the Center for Disease Control, managing your blood sugar levels is important to avoid diabetes-related conditions such as vision loss, heart disease, and kidney disease. Limited research, mostly in animal studies, indicates that without DehydraTECH's noteworthy performance enhancements, generic CBD might be ineffective in controlling blood sugars.
DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH 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 36 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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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.
George Jurcic - Head of Investor Relations
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.