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New York, NY – January 10, 2024 – On Sept. 20, 2019, history was made when the U.S. Food and Drug Administration approved Rybelsus as the first oral glucagon-like peptide-1 (GLP-1) agonist for type 2 diabetes (T2D). However, it wasn’t just a milestone for T2D management. It was a turning point in medicine, opening the floodgates to a universe of potential therapeutic applications for this remarkable molecule. While undeniably transformative for diabetes and weight loss, GLP-1’s reach now extends far beyond, likely surpassing even the wildest dreams of its creators. From Alzheimer’s and Parkinson’s to drug addiction, clinical trials are painting a stunning picture of GLP-1’s versatility. And it doesn’t stop there. Strong evidence points to opportunities in heart disease, chronic kidney disease and a plethora of other conditions. The newfound applications of this super-drug re-enforce the significant potential for Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile), with its powerful DehydraTECH(TM) drug-delivery formulation and processing technology that improves both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. Lexaria joins other companies, including Amgen Inc. (NASDAQ: AMGN), Eli Lilly and Company (NYSE: LLY), Roche (OTCQX: RHHBY) and WW International Inc. (NASDAQ: WW), that are committed to providing powerhouse solutions in the fields of diabetes, weight loss and more.

• GLP-1 agonists are among the hottest drugs in healthcare, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
• Lexaria Bioscience has developed DehydraTECH drug-delivery platform, which is being shown to improve pharmacokinetics of orally administered drugs.
• A pilot study evaluated a dose of the GLP-1 drug Rybelsus to one processed with DehydraTECH, showing Lexaria’s tech improves the safety and efficacy of the drug.
• Lexaria issued final data from the pilot study and is planning for multiple human and animal studies early in 2024.

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

Diabetes and Obesity: A Growing Concern with a Glimmer of Hope

Imagine a silent storm raging inside countless bodies, a chronic battle against rising blood sugar. This is the reality for the 422 million people worldwide battling diabetes, a disease with tentacles that reach far beyond elevated glucose levels. Uncontrolled blood sugar dramatically increases the risk of devastating comorbidities, including kidney disease, vision loss, amputations, heart attacks, strokes and early death.

The storm often gathers strength in the wake of another global health crisis: obesity. Data paints a disturbing picture — 41.9% of U.S. adults now obese, with the worldwide number ballooning to 1.9 billion in 2016 from about 650 million in 1975. This unholy alliance of diabetes and obesity affects a staggering 25% of the world and exacts a heavy toll, not just on health but also on the economy. A conservative estimate puts the global economic burden at more than $2 trillion.

Amid the storm clouds, a glimmer of hope emerges. Enter GLP-1 agonists as a new frontline defense. These drugs mimic a natural gut hormone, prompting the body to produce insulin, regulate blood sugar and even suppress appetite. They’re proving to be powerful weapons in the fight against both diabetes and obesity, offering a chance for a diabetes patient to reclaim control of their blood sugar.

The rising rate of diabetes and obesity diagnoses is creating unprecedented demand for innovative treatments. In 2022, the global diabetes drug market alone surged to $61.87 billion, a figure that pales in comparison to the projected tsunami of spending reaching ~$118 billion by 2032. Scientists are counting on GLP-1 drugs to fight obesity too, another market figured to also top $100 billion in the next decade.

GLP-1 agonists, already blockbusters for diabetes and obesity, are just getting going. That’s the potential Lexaria Bioscience Corp. (NASDAQ: LEXX) unlocks with its DehydraTECH platform. The DehydraTECH solution is designed to enhance drug delivery and efficacy, not only orally but even into the brain for centrally acting compounds. Consider bypassing injections and unlocking new treatment possibilities — that’s DehydraTECH’s revolutionary promise. With proven benefits for oral medications and potential for dissolvable oral applications, Lexaria positions itself at the forefront of maximizing the impact of these life-changing drugs.

Lexaria is initially focused on diabetes and obesity as the low-hanging fruit, but the company isn’t just tackling these indications with its DehydraTECH platform; it’s aiming for a whole menu of medical victories. This disruptive drug-delivery tech boasts faster, better absorption into both bloodstream and brain, making it applicable for conditions such as oral nicotine (where rapid delivery could be a major benefit). This isn’t simply hyperbole. Lexaria recently announced its first human GLP-1 study, with compelling results fueling excitement for a future where DehydraTECH supercharges the molecule’s effect. While diabetes and obesity are tremendous market opportunities, Lexaria is thinking bigger as a platter of medical hope.

DehydraTECH + Rybelsus(TM)

Lexaria Bioscience is aiming to plant its flag in the GLP-1 agonist space with its DehydraTECH platform. After early animal studies hinted at DehydraTECH’s blood-sugar-lowering abilities, the company’s first human test has impressed. DehydraTECH-powered Rybelsus(TM) (oral semaglutide), a blockbuster diabetes drug, lowered blood glucose levels much better than the original alone, possibly thanks to its superior delivery punch to deliver more of the GLP-1 drug into human bloodstream than did Rybelsus itself. It’s early in the game, but Lexaria commands attention to possibly improve the standard of care with a supercharged GLP-1 agonist.

Rybelsus is a top-selling drug in the diabetes market, posting sales of ~$1.63 billion in 2022 and recording $1.234 billion in sales during just the first half of 2023. Moreover, Ozempic, a weekly injectable semaglutide, registered sales of $6.174 billion in the first half of 2023. Recent studies by Lexaria show their platform boosts Rybelsus’ blood-sugar-bludgeoning power, which certainly opens discussions about the potential. The stakes are high to find the most efficacious oral medication considering that injections are a pain point for patients.

The research, conducted by a university researcher, completed a head-to-head comparison of Rybelsus alone versus DehydraTECH-formulated Rybelsus. Compared to a single dose of standard Rybelsus, DehydraTECH-powered Rybelsus showed sustained higher drug levels, quicker peak delivery, superior blood sugar control and even fewer side effects. The seven-participant study hints at a future where oral diabetes drugs could pack a much bigger punch, potentially giving injections a run for their money.

The data speaks volumes. At 24-hours post administration, blood-sugar levels in patients treated with Rybelsus were unchanged from baseline, while those in the DehydraTECH group experienced a 5.01% reduction, a significant improvement. Further, while the control group’s glucose soared 21.7% after a meal, DehydraTECH kept that number locked down to a mere 6.2%, showcasing its superior blood sugar control.

Besting a $1.8 Billion Technology

Armed with this data, Lexaria’s is moving forward with a purpose to validate and capitalize on its initial DehydraTECH results. The company is fast-tracking larger trials to confirm the improved efficacy and safety shown in the most recent research while its focus is firmly fixed on a commercial partnership.

Moving forward, Lexaria is planning to initiate multiple studies further proving the prowess of DehydraTECH. For starters, the company will conduct additional human pilot studies in the next several months to examine another GLP-1 drug as well as evaluate a swallow-free oral dissolvable. It will also launch a multiweek animal pharmacokinetic and efficacy trial to optimize DehydraTECH for weight loss and other performance metrics. Elsewhere, the company is in the planning stages for a long-term stability test program for the purpose of determining if DehydraTECH-formulated GLP-1 drugs can go unrefrigerated during storage, unlike today’s injectable GLP-1 drugs, a factor that will reduce cost and increase logistic simplicity.

Beginning in the April–June quarter, Lexaria has intentions to study DehydraTECH-GLP-1 in a multiweek chronic human trial. In this study, the company will gain insight in both diabetes-related control (in part via reduced blood sugar levels) as well as weight loss and side effects.

Predicting the DehydraTECH impact on the GLP-1 market is a difficult task at this point. The company is rapidly building a data set with the hopes of sealing a deal with an interested pharmaceutical giant. With whispers of efficacy multiplying and side effects diminishing, the potential to disrupt a multibillion-dollar market is, arguably, an achievable target.

To put this into perspective, understand that the last time a drug-delivery technology achieved such an improvement, Novo Nordisk agreed to pay $1.8 billion to acquire Emisphere’s SNAC technology, subsequently putting the technology into Rybelsus tablets. That bears repeating, considering the $1.8 billion technology currently embedded in Rybelsus tablets was just outperformed by DehydraTECH technology.

Proving More Differentiation

GLP-1 drugs are undoubtedly popular due to their efficacy and intriguing safety profile compared to other drugs for the same indications, but they are still far from perfect. Their side effects include diarrhea, vomiting, nausea and more. Plus, they are still somewhat new, so long-term research is ongoing to evaluate delayed effects that could be related to bone density and muscle loss. To wit, DehydraTECH improving pharmacokinetics to reduce side effects can be instrumental in gaining market share in the future.

In the pilot study, DehydraTECH impresses on this front. None of the participants treated with DehydraTECH-formulated Rybelsus experienced any moderate or severe nausea or diarrhea. Conversely, those receiving the Rybelsus control tablets dealt with moderate nausea and diarrhea.

Lexaria isn’t just about blockbuster potential, it’s about smart business. DehydraTECH delivers a double whammy: lower costs for pharma giants and higher demand from patients seeking better delivery and efficacy. And to lock this golden goose in, the company has built a fortress of patents – 38 already granted and counting across the globe.

Only the Beginning

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. Additional companies and studies are investigating the efficacy of GLP-1 drugs on kidney disease, liver disease, bone health and even aging.

Amgen Inc. (NASDAQ: AMGN) is developing Maridebart cafraglutide (formerly AMG 133), or Mari for short. Mari is a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1 receptor agonist. It is being investigated in a phase 2 trial for the treatment of obesity with more than 640 patients, with and without diabetes, enrolled in the study.

Eli Lilly and Company (NYSE: LLY) recently announced  that the U.S. Food and Drug Administration had approved its Zepbound(TM) (tirzepatide) for chronic weight management, a powerful new option for the treatment of obesity or overweight with weight-related medical problems. Adults taking Zepbound in a clinical trial lost on average 48 pounds at the highest dose. Zepbound is the first and only approved treatment activating two incretin hormone receptors, GIP and GLP-1, to tackle an underlying cause of excess weight.

Roche (OTCQX: RHHBY) announced last month that it had entered into a definitive merger agreement to acquire Carmot Therapeutics Inc., a privately owned U.S. company based in California. Carmot’s R&D portfolio includes clinical-stage subcutaneous and oral incretins with best-in-class potential to treat obesity in patients with and without diabetes, as well as a number of preclinical programs. The announcement noted that existing clinical data for Carmot’s assets, especially the lead asset CT-388, suggests potential to achieve and maintain weight loss with differentiated efficacy.

WW International Inc. (NASDAQ: WW) last month launched a new behavior-change program designed to support the unique needs of individuals on GLP-1 medications. The WeightWatchers GLP-1 Program was developed by a team of obesity specialists, clinicians, behavior-change scientists, dietitians and fitness experts to solve a gap in the market as members navigate life on new weight-loss medications.

GLP-1 has transcended its initial promise — its story is now a thrilling saga of scientific exploration and medical triumph. The implications are vast, not only for the millions struggling with diverse ailments but for the future of medicine itself. This is just the beginning. The curtain has risen on a new era, where GLP-1, the once-humble diabetes drug, stands poised to rewrite the script for countless medical journeys.

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

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