KELOWNA, BC / ACCESSWIRE / November 26, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following strategic update.
Today's GLP-1 drug market consists primarily of semaglutide (Wegovy®, Ozempic®, and Rybelsus®), owned by Novo Nordisk®; and tirzepatide (Zepbound®, Mounjaro®), owned by Eli Lilly™. All five of those drug brands, with the exception of Rybelsus®, are administered by injection, whereas Rybelsus® is the only oral tablet currently approved by the FDA today. While these two drugs were originally approved by the FDA for diabetes management, weight-loss approvals soon followed and Wegovy® was also approved by the FDA in March 2024 to reduce the risk of cardiovascular death, heart attack and stroke.
Acceptance and use of these two drugs by the public has resulted in unprecedented demand, with estimates of 2024 revenue between them of ~$30 billion, compared to just $300 million in 2018, an increase of 100x or 10,000%.
"The GLP-1 market may be the most significant development in pharmaceutical achievements of our lifetimes," said Richard Christopher, CEO of Lexaria. "Given the relatively early stage of investigation and development of these drugs, we simply do not know how big of an impact they will have, but it is safe to say that nearly every person in Europe or North America could experience improvement in their own health, or the health of a loved one, from GLP-1 drugs."
Some are asking whether this trend is a temporary one-off event and whether the recent revenue growth is sustainable; whereas there is a growing realization that - not only is this NOT a temporary event - future revenue growth is likely to be even stronger than that seen in recent years.
There are two main reasons for the growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year: one is that the patient population for diabetes, weight loss, and heart disease is massive and growing, with these drugs demonstrating good overall safety and efficacy. The other reason is that it seems quite likely that the therapeutic benefits from using these drugs is poised for significant expansion based on the evidence that is continually being updated.
Cardiovascular Disease
Recently, Novo Nordisk® announced that Rybelsus® demonstrated a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes, in a large Phase III trial of 9,650 people. With Wegovy® already FDA-approved for certain cardiovascular disease treatments, Novo Nordisk® will now be seeking FDA approval of Rybelsus® for similar use.
Liver Disease
There are currently no FDA-approved treatments for metabolic dysfunction-associated steatohepatitis ("MASH") liver disease, or for non-alcoholic fatty liver disease. GLP-1RAs have been reported to reduce liver fat content and liver enzymes, reduce oxidative stress and improve hepatic de novo lipogenesis and the histopathology of MASH. The MASH treatment market is forecasted to possibly reach $20 billion by 2032. Of the several leading pharmaceutical companies exploring treatment options for MASH, Pfizer is investigating its own GLP-1 molecule, danuglipron, as a potential daily tablet solution but is too early in its development to have received FDA approval at this time.
In 2020, Merck® agreed to pay up to $860 million in milestone payments to acquire the rights and licence to efinopegdutide, a GLP-1/GIP drug that was granted a Fast Track designation from the FDA in 2023 for the treatment of MASH.
Boehringer Ingelheim® has also been granted a Fast Track designation from the FDA for its molecule survodutide, yet another GLP-1 drug originally designed for application with obesity but now additionally being examined for certain liver diseases.
Not to be outdone, Novo Nordisk® has also reported that those who are overweight place additional stress on the knee and its protective cartilage and that in a study of 407 people diagnosed with knee arthritis, knee pain was reduced more thoroughly when those patients were treated with semaglutide than when they received a placebo.
Alzheimer's and Dementia
While GLP-1 drugs are known for triggering gastro-intestinal effects that create a sense of fullness, thus facilitating the treatment of obesity and diabetes, many investors have not yet realized that GLP-1 and related drugs have actions at main types of human brain receptors. Commercially available GLP-1 drugs have already shown an ability to bind with those receptors, but if and only if they are capable of crossing the blood-brain-barrier sufficiently upon administration. Lexaria has repeatedly shown, in previous studies with other drugs, that its DehydraTECH technology can at times improve the delivery of drugs into brain tissue. Lexaria's recently completed animal study WEIGHT-A24-1, is investigating for the brain absorption of DehydraTECH-processed GLP-1 drugs in study animals with data pending and expected to be released in either December, or in January, 2025.
Dulaglutide, owned by Eli Lilly™, is a GLP-1 drug that has shown a particular affinity to enter the brain, and, in a large human study of 8,828 participants, it has shown a significant benefit to cognition.
Eli Lilly™ is conducting active research including a Phase II study expected to complete in early 2026, examining tirzepatide as a possible treatment for chronic kidney disease ("CKD"). If successful it is reasonable to expect Eli Lilly™ to progress to Phase III development and ultimately apply to the FDA for approval of the use of tirzepatide to treat this often life-threatening condition if successful.
Further, in a large analysis of over 165,000 patients, type-2 diabetic patients with acute kidney disease receiving GLP-1 drugs evidenced lower mortality rates and lower incidences of both major cardiovascular events and major adverse kidney events, than those patients not receiving GLP-1 drugs.
As well, Novo Nordisk® has earlier announced a successful outcome of a human trial of 3,533 people with CKD and type 2 diabetes using injected semaglutide. The study "demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24%."
Conclusion
The applications of GLP-1 and related drugs are still being identified. Given the widespread and rapid adoption of these drugs by tens of millions of people, data is being generated in real time at a scale never encountered before. The benefits of weight loss and diabetic control are obvious though not even close to being fully realized at this time, while the benefits in other areas of human health are still being discovered. Lexaria intends to continue research and development of its DehydraTECH drug delivery platform technology with as many GLP-1 and related drug molecules as it possibly can, in an attempt to identify broad areas of prospective commercial applicability for it to continue to participate in arguably the most exciting field of drug development in modern times.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 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 46 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 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
