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New York, NY – January 8, 2024 – Already proven to be a revolutionary treatment for type 2 diabetes and weight loss, glucagon-like peptide-1 (GLP-1) agonists now appear to have a multitude of potential blockbuster therapeutic uses, according to recent research. Obviously, diabetes remains a primary indication, given the massive global need. However, the impact of this extraordinary molecule extends far beyond type 2 diabetes. The reach of GLP-1 drugs has widened in ways its inventors likely never imagined. Clinical trials are underway testing GLP-1 drugs to treat Alzheimer’s, Parkinson’s, and even drug addiction, plus there are strong indications of therapeutic efficacy in heart disease and chronic kidney disease, as well as a wide range of other conditions, including weight loss. The newfound applications of this super-drug re-enforce both the reach and impact of Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile). By supercharging GLP-1 drugs with its DehydraTECH(TM) drug-delivery formulation and processing technology, Lexaria intends to improve both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. With several key studies on the near-term horizon, Lexaria has positioned itself in the midst of these market opportunities alongside others changing the landscape, such as Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), AstraZeneca PLC (NASDAQ: AZN) and Novo Nordisk (NYSE: NVO).

• GLP-1 agonists are the hottest drugs in healthcare today, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
• Lexaria Bioscience is utilizing its patented DehydraTECH drug-delivery platform to improve the way active molecules enter the bloodstream upon oral ingestion.
• A pilot study showed that a DehydraTECH-processed form of blockbuster Rybelsus (a GLP-1) was more effective controlling blood glucose than standard Rybelsus.
• Lexaria recently received final data from the study and plans to conduct additional human studies during Q1 2024.

Click here to view the custom infographic of the Lexaria Bioscience Corp. editorial.

GLP-1: A Therapeutic Oasis

GLP-1 agonists have emerged as the preferred weapons in the fight against diabetes, a disease affecting some 422 million people worldwide. Prolonged elevated blood sugar from diabetes results in significantly higher risk for serious comorbidities such as kidney disease, vision loss, heart and cardiovascular disease, and more. Diabetes is often closely connected to obesity, a common global health concern, and the relationship is disconcerting. Data collected between 2017 and 2020 showed 41.9% of adults in the United States are obese, and worldwide, obesity tripled from 1975 to more than 1.9 billion in 2016. With diabetes and obesity affecting some 25% of the world, the global impact on both health and economy is enormous, with one study reporting a conservative estimate of more than a $2 trillion global economic burden.

Little wonder the global diabetes drug market, estimated at $61.87 billion in 2022, is projected to explode to ~$118 billion by 2032. Similarly, product sales for obesity drugs are forecast to reach $100 billion within a decade, and the most promising drugs at the head of the pack are GLP-1 agonists.

With each new study, the horizon of GLP-1’s therapeutic potential expands, painting a vibrant picture of a future where a single molecule could tackle a multitude of human afflictions, including neurological disorders (e.g., Alzheimer’s and Parkinson’s), cardiovascular conditions (e.g., heart disease, high blood pressure, atherosclerotic plaques, inflammation), cancer, autoimmune disease (e.g., Crohn’s), and many new possibilities; studies are investigating the efficacy of GLP-1 drugs on kidney disease, liver disease, bone health and even aging.

With so many proven and potential blockbuster indications, enhanced delivery and increased efficacy would supercharge the impact of GLP-1 agonists. Lexaria Bioscience Corp. (NASDAQ: LEXX) intends to do just that with its patented DehydraTECH platform developed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has demonstrated enhanced delivery of certain active molecules into brain tissue, which has particular importance for centrally active compounds via oral administration. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bioabsorption when administered intraorally (sublingual or tissues of the mouth).

The company’s initial focus is on diabetes and obesity with a bevy of other conditions on tap for upcoming studies of the disruptive drug-delivery platform, including oral nicotine where its rapid and effective drug absorption into the bloodstream and brain tissue is theorized as highly beneficial. The company just received final results from its first human pilot study of GLP-1, and those results are very positive.

DehydraTECH Enhancing Approved Drugs

Lexaria began its DehydraTECH diabetes-related formal studies in 2022. The company’s first-generation DehydraTECH research in animal studies reduced blood-sugar levels and lowered body weight. In recent days, Lexaria’s results within its diabetes and weight-loss study program have significantly improved, including results from the company’s first human study investigating GLP-1. Eye-popping results showed DehydraTECH-processed Rybelsus(TM) (oral semaglutide) was more effective at controlling blood glucose than standard Rybelsus alone. That might be because DehydraTECH delivered more of the GLP-1 drug into human bloodstream than did Rybelsus(TM) itself. Lexaria may have changed treatment efficacy with a supercharged GLP-1 agonist.

These results dovetailed with other details from the recent study showcasing the potential for DehydraTECH to make a blockbuster drug better. Rybelsus is one of the most popular drugs in the diabetes market, posting sales of ~$1.63 billion in 2022 and already posting $1.234 billion in sales during just the first half of 2023. By comparison, Ozempic, a weekly injectable semaglutide, posted sales of $6.174 billion in the first half of 2023. Injectables may be the best-selling drugs, but they are the least favorite delivery method and an impetus for a more powerful oral drug.

Lexaria’s study was performed by a university research center that compared a control group receiving a single dose of a Rybelsus tablet to a treatment group receiving a matching dose of Rybelsus that had been formulated using DehydraTECH processing-technology enhancements. Data from the pilot study (n=7) showed the DehydraTECH-processed Rybelsus led to sustained higher levels of semaglutide in blood, faster achievement of peak drug delivery, better control of blood glucose, and reduced side effects.

Twenty-four hours after administration, blood glucose levels in the Rybelsus control group were unchanged from baseline, compared to a 5.01% reduction for the DehydraTECH GLP-1 treatment group, an obvious improvement. Furthermore, the data showed the control group to experience a 21.7% spike in glucose levels after a meal, versus just a 6.2% increase in the DehydraTECH treatment group.

Up Next: Building a Commercial Data Set. . .

Lexaria intends to replicate and further validate the enormously enhanced efficacy and reaffirm the safety of its technology in larger-scale studies for statistically significant analysis as soon as possible. Lexaria has been clear that it wants to attract a commercial partner.

During the next several months, Lexaria is planning to begin more human pilot studies expected to test at least one additional GLP-1 drug as well as test an oral dissolvable that is not required to be swallowed. It is also planning to start a very large and comprehensive multiweek animal pharmacokinetic and efficacy modelling study program using different DehydraTECH compositions and different GLP-1 drug molecules. Although all study plans might change, that animal study will specifically measure weight loss and other performance indicators over a multi-week period. Lexaria is also planning to begin a long-term stability test program to discover whether DehydraTECH formulated GLP-1 drugs can avoid refrigeration during storage, unlike existing injectable GLP-1 drugs that require costly refrigerated manufacturing and storage conditions.

In Q2 2024, Lexaria intends to study DehydraTECH-GLP-1 in a multiweek human clinical trial to examine both diabetes-related control (in part via reduced blood sugar levels) as well as weight loss and side effects.

It’s difficult to estimate the potential impact of Lexaria’s DehydraTECH on the GLP-1 drug market. Lexaria is moving quickly to build a thorough data set that it hopes will lead to an agreement with one of the giant pharmaceutical players in the global GLP-1 space. However, with early indications of a manyfold increase in efficacy, the technology could disrupt a booming multibillion-dollar market.

The last time a drug-delivery technology achieved that, Novo Nordisk agreed to pay $1.8 billion to acquire Emisphere’s SNAC technology, which it placed into its Rybelsus tablets. That’s right: the $1.8 billion technology already embedded within every Rybelsus tablet was just bested by Lexaria’s DehydraTECH.

. . . And Further Differentiation

While GLP-1 drugs are touted for their efficacy and compelling safety profile, they still can trigger nausea, vomiting, diarrhea and more. In addition, ongoing research is examining long-term effects related to bone density and muscle loss. Improving side effects is critical for market share as the GLP-1 market matures. Lexaria is working to deliver on this front as well.

In the first human pilot study, DehydraTECH again showed evidence of its prowess. Not a single one of the people receiving DehydraTECH formulated Rybelsus experienced any moderate or severe nausea or diarrhea, whereas the Rybelsus control tablets alone did provoke moderate nausea and diarrhea.

Other benefits are realized in the aggregate through the value of improved pharmacokinetics and delivery methods, namely lowered costs and greater patient demand. Lexaria has protected its DehydraTECH technology with a patent portfolio already comprised of 38 granted patents in the United States, Canada, Mexico, Japan, Australia, India and the European Union, with more patent applications pending around the world.

Changing Outcomes

GLP-1 drugs are arguably the hottest topic in healthcare today. They’ve proven to have a positive effect on type 2 diabetes and a meaningful impact on weight loss. New research indicates a plethora of other potential blockbuster applications that could change protocols and outcomes for millions of people with a myriad of maladies. GLP-1 will likely stay in the spotlight for years to come with numerous companies targeting improvements and market share.

Pfizer Inc. (NYSE: PFE) this month announced topline data from the phase 2b clinical trial investigating its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron, in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline.

Merck & Company Inc. (NYSE: MRK) is approaching GLP-1 agonists from different angles. In August, Merck entered an exclusive licensing agreement with Hanmi Pharmaceutical for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), Hanmi’s investigational once-weekly GLP-1/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis.

AstraZeneca PLC (NASDAQ: AZN), a global, science-led biopharmaceutical company, has entered into an exclusive license agreement with Eccogene for ECC5004, an investigational oral once-daily GLP-1RA for the treatment of obesity, type 2 diabetes and other cardiometabolic conditions. Preliminary results from the phase I trial have shown a differentiating clinical profile for ECC5004, with good tolerability and encouraging glucose and body-weight reduction across the dose levels tested compared to placebo.

Novo Nordisk (NYSE: NVO), the owner of Ozempic(R), Rybelsus(R), Victoza(R) and Wegovy(R), is a world leader in diabetes and GLP-1 drugs. In the first nine months of 2023, sales within diabetes and obesity care increased by 36% in Danish kroner to DKK 153.8 billion (40% at CER (constant exchange rate), mainly driven by GLP-1 diabetes sales growth of 45% in Danish kroner (49% at CER) and obesity care growing by 167% in Danish kroner to DKK 30.4 billion (174% at CER).

Pharma giants around the world are looking for ways to cement a GLP-1 foothold whether it’s for diabetes, obesity or new indications. It appears certain that GLP-1 is here to stay, and indications for use will likely expand beyond expectations. Companies that enhance efficacy and expand usage could prove to be the biggest winners in the progression of GLP-1 drugs.

For more information about Lexaria Bioscience Corp., please visit Lexaria Bioscience Corp.

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