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NEW YORK, Oct. 30, 2023 /PRNewswire/ — The prestigious New England Journal of Medicine recently published results of a large study of 2,539 adults wherein weight loss of 49 to 52 pounds was a common outcome. With more than 37 million Americans suffering from diabetes, and with obesity at epidemic levels, it’s little wonder that millions of people are singing their praises of the new class of drugs responsible for these outrageously positive outcomes. GLP-1 agonists are a class of medications that mainly help manage blood sugar (glucose) levels in people with type 2 diabetes but are also helping treat obesity. Seems everyone is excited about controlling blood sugar and easily losing weight. But there may be an even better avenue to increased effectiveness and better outcomes. Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), a global innovator in drug-delivery platforms, began diabetes-related formal studies last year with its DehydraTECH(TM) platform, which showed reduced blood-sugar levels and lowered body weight. With such encouraging early results, Lexaria is planning to launch new human and animal studies to examine whether DehydraTECH processing can make GLP-1 drugs such as semaglutide even better. Lexaria’s heavily-patented DehydraTECH drug delivery technology might  improve bioavailability, lower costs, and enhance tolerability, weight-loss potential and management of diabetes and other health conditions. DehydraTECH may become a game changer in the multibillion-dollar GLP-1 drug market and could potentially lead to a collaboration with a dominant player in the space, such as Novo Nordisk (NYSE: NVO), Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), or AstraZeneca PLC (NASDAQ: AZN).

• Lexaria’s DehydraTECH is easily integrated into oral product manufacturing processes to better deliver API payloads to improve bioavailability, reduce side effects and more.
• Lexaria is evaluating the impact of DehydraTECH on oral performance of GLP-1 drugs  for diabetes and weight loss, a market forecast to reach up to an astonishing $200 billion per year.
• DehydraTECH is a scalable technology for a multitude of applications that has separately been licensed by Altria for oral nicotine products.
• DehydraTECH promotes fast-acting, less expensive and more effective oral drug delivery and has been thoroughly evaluated through in vivo, in vitro and human clinical testing.

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

Diabetes and Obesity Rates Soaring

According to the U.S. Centers for Disease Control and Prevention, 37.3 million Americans have diabetes, while another 95 million adults, one in three, have prediabetes, of which 80% are unaware of having it. Globally, the World Health Organization estimates 422 million people had diabetes in 2014, nearly quadruple the number in 1980. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world. The CDC says that obesity prevalence in the United States was a whopping 41.9% in 2017. The WHO shows that more than 1.9 billion people worldwide were overweight in 2016, underscoring the spike in diabetes diagnoses.

Against this backdrop, it shouldn’t be surprising that analysts at Markets and Research estimate the global diabetes drug market at $63.1 billion in 2021 on its way to $82.93 billion in 2027, while the global market for diabetes devices was valued at another $26.1 billion and growing 7.5% annually. 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. Some of the most popular type 2 diabetes in recent years are GLP-1 (glucagon-like peptide-1) receptor agonists. They work by mimicking the effects of the naturally occurring hormone GLP-1, which helps to regulate blood sugar levels and appetite.

Lexaria Bioscience Corp. (NASDAQ: LEXX) began its DehydraTECH diabetes-related formal studies in 2022 with compelling data highly relevant to diabetes showing positive effects of lowering glucose levels, body weight and triglyceride levels, as well as evidenced increased locomotor activity. With such positive early results, Lexaria is expanding its diabetes study program, including using DehydraTECH for GLP-1 drugs alone and in combination with other molecules.

More precisely, the company is adding to a growing body of evidence showing that DehydraTECH improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery, the preferred method of drug delivery by patients. The company has already evidenced the tech to improve the pharmacokinetics of a variety of drugs, including PDE5 inhibitors and antiviral drugs, as well as facilitate the transfer of drugs across the blood-brain barrier, a notoriously challenging component in drug development and potential key to treating addiction and neurodegenerative brain disease.

Now Lexaria has its sights set on diabetes and obesity.

Lexaria will launch new human and animal studies to examine DehydraTECH-processed GLP-1 drugs including but not limited to semaglutide, which is sold under Novo Nordisk’s brand names Ozempic, Wegovy and Rybelsus. The studies will evaluate its technology platform for improved bioavailability, cost effectiveness, tolerability, weight-loss potential, management of diabetes and more. Per the drug value formulation calculations of Bay Bridge Bio, Lexaria is at a launch point in the valuation curve with the upcoming clinical studies.

DehydraTECH in Four Sentences

DehydraTECH technology is incorporated into the formulation and manufacturing process of existing or new orally ingestible and topical products. It involves mixing the API as a delivery payload with certain fatty acids, infusing the mixture into a substrate material, and then using controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level. The newly combined molecules are then integrated into end-product production across a range of dosage form factors including pills and capsules.

The output is essentially tasteless and odorless and works symbiotically with physiological systems to enable improved and faster absorption of drugs into the bloodstream and brain tissues. Brilliantly simple from the top level, Lexaria has turned a complex process into a scalable platform applicable for a litany of both current and future drugs.

GLP-1 Changing History

Historically, weight-loss drugs have been highly touted and equally miserable failures (think Fen-phen, meridian, ephedra, to name a few). Demand is understandable; hundreds of millions of overweight people are hungry for something that can help them lose weight and keep it off. To wit, analysts have repeatedly pegged multibillion sales projections for drugs successfully penetrating this market.

GLP-1 drugs are changing the course of weight-loss history, and Lexaria intends to be a leader 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.” That would be a real game changer in a burgeoning multibillion-dollar market.

In recent years, GLP-1 drugs realized success by targeting a novel mechanism of action to activate hormones regulating glucose while simultaneously decreasing appetite and stomach emptying. Showing this can be done safely and effectively, several drugs have earned approvals from the U.S. Food and Drug Administration for type 2 diabetes and weight-loss management. New research strongly suggests that GLP-1 can also curb cravings for drinking, smoking and other addictive behaviors, indications perfectly aligned for Lexaria’s DehydraTECH platform.

Making Good Even Better

Most approved GLP-1 drugs are injectables, which has started a race for diabetes/weight-loss drugs in oral form including the objective to minimize current adverse side effects such as nausea, vomiting and diarrhea, among others. This is exactly where Lexaria sees an enormous opportunity for DehydraTECH based upon results with other types of drugs that lessened negative side effects.  

Oral drugs are not only preferred for drug delivery by patients, but they are also far less expensive than the $900 per month in costs that is common for a regimen of a GLP-1 injectables. If successful in developing an oral option, Lexaria could find itself in a commanding position in a market for GLP-1 drugs that analysts say could balloon to $150 billion to $200 billion. That’s a lot of headroom for a company with a market capitalization currently under $15 million.

Patented. Literally.

Lexaria’s unique drug-delivery technology is validated by a wide-ranging patent portfolio. The technology is protected by 37 patents around the world covering antiviral drugs, specific molecules for hypertension and central nervous system disorders, nicotine, NSAIDs (non-steroidal anti-inflammatory drugs) and vitamins. Also in development are patents pending that will further galvanize DehydraTECH for hypertension, hormone treatments and other drug formulations.

Lexaria has already caught the attention of tobacco juggernaut Altria, which has licensed Lexaria’s DehydraTECH and agreed to pay royalties on any oral nicotine product sales. This alone could be a company maker as DehydraTECH makes reduced risk noncombustible nicotine possible, which could contribute to decreasing the more than 7 million deaths attributed to smoking every year and help Altria with its mission to move “beyond smoking.”

This Ball Is Just Getting Rolling

The opportunity for Lexaria is undergirded by recent results and the progress of majors actively in the diabetes and weight-loss markets. In fact, it is arguable that the fervor for these types of drugs is only in the early stages as drug makers parlay diabetes drugs into weight-loss medications and likely much more, effectively expanding markets and revenue while greatly slashing development costs.

Novo Nordisk (NYSE: NVO) is a leader in diabetes and obesity medicines. In June, Novo Nordisk said that it is taking actions to protect U.S. patients from the unlawful marketing and sales of non-FDA approved counterfeit and compounded semaglutide products claiming to contain semaglutide, while reinforcing the responsible use of Novo Nordisk’s FDA-approved medicines. Novo Nordisk’s prescription-only, FDA-approved semaglutide medicines are Wegovy(R) for chronic weight management along with Ozempic(R) and Rybelsus(R) for type 2 diabetes.

Pfizer Inc. (NYSE: PFE) is leveraging its small molecule design expertise, continuing advancement of the clinical program for danuglipron (PF-06882961), subject to results from the ongoing phase 2 trial. Danuglipron is the largest oral, small molecule GLP-1-RA clinical development program underway with more than 1,400 participants enrolled for the treatment of obesity and type 2 diabetes. The company expects to finalize plans for the danuglipron late-stage program by the end of 2023 and also is developing a once-daily modified release version.

Merck & Company Inc.’s (NYSE: MRK) oral GLP-1 drug MK-6024 (efinopegdutide) activates glucagon receptors to increase energy expenditure and reduce food intake. Recently, the drug, which isn’t specifically being developed as a weight-loss substance, was granted Fast Track Designation from the FDA as a potential treatment for patients with nonalcoholic steatohepatitis (NASH), a more severe form of nonalcoholic fatty liver disease (NAFLD) that includes inflammation and damage to the liver. MK-6024 is an investigational peptide and dual agonist at GLP-1 and glucagon receptors.

AstraZeneca PLC (NASDAQ: AZN) has successfully developed and commercialized Farxiga (dapagliflozin) as a treatment for Type 2 diabetes, chronic kidney disease and heart failure. Farxiga is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Farxiga’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs — important findings given the underlying links between the heart, kidneys and pancreas. In May, Farxiga was approved in the United States to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure (HF) visits in adults with HF.

The combined demographic for diabetes and weight loss might be the largest in the world. Recent treatment successes have set the market ablaze, creating enormous opportunity both now and well into the future.

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

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