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New York, NY – November 1, 2023 – GLP-1 agonists have become incredibly popular obesity drugs, reshaping the standard of care as people increasingly turn to the new class of drugs in lieu of conventional weight-loss procedures. There is a growing body of clinical evidence showing GLP-1 agonists safely control blood sugar (glucose) levels and deliver tremendous positive outcomes, such as a recent New England Journal of Medicine study reporting weight loss of 49 to 52 pounds. As good as GLP-1 agonist are, they can get better, which is part of the mission of Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), a global innovator in drug-delivery platforms. The company started diabetes-related formal studies in 2022 evaluating its DehydraTECH(TM) platform, which showed lower blood-sugar levels and decreased body weight. This compelling data is undergirding the next phase of research, new human and animal studies for the purpose of demonstrating DehydraTECH processing can make GLP-1 drugs even more effective and more accessible. Positive developments on DehydraTECH could catch the attention of companies dedicated to developing drugs that support better health— companies such as Johnson & Johnson (NYSE: JNJ), Sanofi (NYSE: SNY), Amgen (NASDAQ: AMGN), and Novartis AG (NYSE: NVS).

• Lexaria’s DehydraTECH is a platform technology that seamlessly integrates in manufacturing processes to enhance delivery of API payloads, subsequently improving pharmacokinetics and reduce side effects.
• Lexaria is researching the effect of DehydraTECH on oral performance of GLP-1 drugs for diabetes and weight loss, markets expected to climb to $200 billion annually.
• DehydraTECH is scalable and shown to have utility for a multitude of applications, including oral nicotine products, for which Altria has secured rights from Lexaria.
• DehydraTECH promotes rapid uptake and better efficacy through less expensive, oral administration, as validated through laboratory and clinical testing.

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

A Dire Need for New Therapies

The number of people dealing with chronic, serious health challenges, including diabetes, obesity and hypertension, is spiraling out of control. The U.S. Centers for Disease Control and Prevention estimates that 37.3 million Americans have diabetes today, while nearly 100 million more adults have prediabetes. What’s more, an estimated 8 out of 10 don’t even know they are prediabetic and are unaware of the potential problems they could face in the future. Worldwide, the numbers are equally depressing. The World Health Organization estimates 422 million people were living with diabetes in 2014, a four-fold increase from 1980.

Obesity and hypertension are common culprits in diabetes, and diagnoses have reached epic proportions, including 41.9% incidence in the U.S. in 2017. Globally, the number of obese people is a staggering 1.9 billion, lending some color as to why diabetes rates are spiking. And WHO reports that an estimated 1.28 billion adults worldwide have hypertension.

Numbers like these lead to astronomical market opportunities. Markets and Research sees the global diabetes drug market at $63.1 billion in 2021 on its way to $82.93 billion in 2027. Without question, one of the most popular type of diabetes medicines to hit the market in recent years are GLP-1 (glucagon-like peptide-1) receptor agonists. These work by imitating the effects of GLP-1, a hormone involved in regulating glucose and hunger.

Lexaria Bioscience Corp. (NASDAQ: LEXX) has amassed highly compelling data since initiating diabetes-related formal studies last year. The effects have been multifold, comprised of lower glucose levels, body weight and triglyceride levels with the added perk of increased locomotor activity. This positive data has set the stage for Lexaria to widen its diabetes study program, namely using DehydraTECH to process and deliver GLP-1 drugs either alone or in combination with other compounds.

Completed work on DehydraTECH has repeatedly shown it to improve therapeutic profiles of active pharmaceutical ingredients (APIs). The DehydraTECH process improves the way APIs enter the bloodstream through oral administration, while further improving the pharmacokinetics of several types of drugs, including PDE5 inhibitors and antiviral medicines. Moreover, the technology aids in APIs crossing the blood-brain barrier, which can potentially unlock new medicines for areas of great unmet medical need, such as neurodegenerative brain diseases and addictions.

Now diabetes, obesity and hypertension are targets too, making Lexaria’s portfolio all the more attractive.

Lexaria intends to initiate new human and animal studies to examine GLP-1 drugs processed with DehydraTECH. Some of these drugs are the most highly valued today, such as Wegovy(R), Rybelsus(R) and Ozempic(R). Outcomes with evaluate DehydraTECH’s ability to improve bioavailability, cost effectiveness, tolerability, weight-loss potential, management of diabetes and more. This puts Lexaria at a key inflection point where biotechs can surge in value, according to calculations proffered by Bay Bridge Bio.

Understanding DehydraTECH

Years of work have gone into developing DehydraTECH to position it as an integral component to the next generation of drugs. Obviously high tech, the platform is brilliant in its design and simplicity, easily integrated into the formulation and manufacturing process of existing or new orally delivered or topical products.

The DehydraTECH process includes mixing the API with specific fatty acids and infusing the combination into a substrate material. That is followed by a controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level. Next, the newly combined molecules go through a final product production, with the output being a variety of doses in different forms, such as capsules or pills.

Tasteless and odorless, the end product works harmoniously with physiological systems. The API is absorbed more quickly into brain tissues and the bloodstream. Effectively, Lexaria has taken a highly complex process and turned it into a scalable platform easily integrated into systems for making drugs today and those of the future.

A New Chapter in Weight-Loss Medicines

There is a long list of drugs that were touted to be blockbusters for weight loss that ultimately failed miserably. Ephedra, Meridian, and Fen-phen come to mind. With 1.9 billion obese people worldwide, it is not difficult to understand why everyone from drugmakers to analysts to doctors and patients get excited about safely and effectively tapping the market.

Where those drugs have failed, GLP-1 drugs are succeeding and reversing the negative stigma of weight-loss drugs. Lexaria is set to play a key role in shepherding in the next generation of these drugs. The company said in September that its planned trials of new formulations of GLP-1 drugs “could enable drug delivery via oral capsule at lower costs than current injectables, with reduced side effects and enhanced health benefits.” This is company maker potential, as Lexaria stands alone with DehydraTECH, with nothing else like it currently available.

GLP-1 drugs are experiencing booming sales by taking a new route, a pathway known as a “mechanism of action.” The drugs are remarkably good at activating hormones that regulate glucose while concurrently reducing appetite and stomach emptying. Clinical trials have shown risks to be outweighed by benefits, leading to several new drug approvals by the FDA for weight control and management of type 2 diabetes. If addition, research has emerged that GLP-1 drugs show potential to be effective in curbing cravings for addictions, such as alcohol and nicotine, more indications that Lexaria can put in its crosshairs in the future for use with DehydraTECH.

Good Becomes Great

GLP-1 drugs are impressive, but they are not perfect. This relatively new class of drugs may be associated with certain adverse effects that can keep many people from tolerating the medicine. There are a spate of articles available on the web detailing the potential for side effects, including nausea, vomiting and potentially even stomach paralysis and pancreatitis. The drugs have even been the topic of an investigation by European regulators looking into increased risk of suicidal thoughts in patients on the medications.

To wit, there is a tremendous opportunity to make modifications to these and other drugs to control or even eliminate serious negative effects. What would the value be to improve a blockbuster? For Lexaria, DehydraTECH has the potential to mitigate adverse events by either improving the delivery process or increasing the effectiveness, which can mean lower doses or fewer side effects — or both. Based upon the work by Lexaria with other drugs that showed a marked reduction in negative side effects, it seems plausible that a similar positive effect could be achievable in GLP-1 drugs.

In addition, most approved GLP-1 drugs are injectables, not the ideal method for most patients. Plus, injectables are more expensive for both the manufacturer and patient. It is not uncommon for a monthly regimen of a GLP-1 injectable to cost up to $900. If successful in developing an oral option, Lexaria could find itself in an enviable position in a GLP-1 drug market forecast to reach $150 billion to $200 billion. If so, the days of a $15 million market cap for Lexaria could be ancient history.

Heavily Protected

Lexaria has an impressive patent estate protecting its unique technology. The IP portfolio includes 37 domestic and international patents spanning antiviral drugs, specific molecules for hypertension and central nervous system disorders, nicotine, NSAIDs (non-steroidal anti-inflammatory drugs) and vitamins. Management is relentless in its patent pursuit, with more pending globally to further cement DehydraTECH’s utility, including uses for hypertension, hormone treatments and other drug formulations.

The company is starting to get noticed by major players. Tobacco behemoth Altria has already licensed DehydraTECH, agreeing to pay Lexaria royalties on future oral nicotine product sales. The idea is DehydraTECH could be instrumental in making reduced risk non-combustible nicotine products for the purpose of reducing the millions of deaths each year attributed to cigarette smoking. For many companies, this alone would be enough to get investors excited, but for Lexaria, it’s just one potential revenue stream.

Train Just Getting Going

GLP-1 drugs are definitely a hot topic, but the science is still relatively young. Companies such as Lexaria have the potential to improve outcomes and expand into an array of new areas. The company is not alone in its pursuit of new drugs and delivery methods to give caregivers and patients new options. In reality, it is still early in what could be one of the most exciting areas of medicine in the coming decades by providing relief to arguably two of the areas of greatest need worldwide.

Johnson & Johnson (NYSE: JNJ) is one of the world’s largest healthcare companies, with several units contributing to the top and bottom lines. The company’s Medtech segment, which relies in part on demand for gastric bypass and other bariatric surgeries, generated third-quarter sales of $7.46 billion, up from $6.78 billion in the year prior quarter. CEO and chairman Joaquin Duato sees potential synergies for surgery and GLP-1 meds, saying in a Q3 call, “Overall, when we talk to surgeons, bariatric surgeons, what they see is a complementary role of surgery and GLP-1s and many of them comment on the fact that they could see a tailwind for bariatric surgery down the road given this complementary nature, the increased awareness about obesity, more patients seeking treatment.”

Sanofi (NYSE: SNY) made an important move earlier this year to bolster its portfolio, agreeing to pay $2.9 billion to acquire Provention Bio Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes. The transaction added an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile.

Amgen Inc. (NASDAQ: AMGN) is developing maridebart cafraglutide (formerly AMG 133) for obesity. Amgen is conducting a phase 2 study of maridebart cafraglutide, a multispecific molecule that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon-like peptide 1 (GLP-1) receptor in overweight or obese adults with or without type 2 diabetes mellitus. Last year, the company presented data on a first-in-human study that evaluated the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes (NCT04478708) at the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) Hybrid Conference.

Novartis AG (NYSE: NVS) is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, Novartis uses innovative science and digital technologies to create transformative treatments in areas of great medical need. The company is currently conducting an efficacy, safety, tolerability and dose-finding study of XXB750 in resistant hypertension patients. The purpose of the 20-week randomized double-blind study is to evaluate the efficacy, safety and tolerability of different doses of XXB750 administered as subcutaneous injections, compared to placebo.

Studies indicate that the combined demographic for diabetes, hypertension and weight loss have potential to be among the largest in the world. The recent emergence of new treatment options that are showing significant success have sparked enormous global potential.

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

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