The Power of Science to Stop a Killer

 NetworkNewsWire Editorial Coverage: Nearly half of all American adults suffer from hypertension (high blood pressure), often referred to as a silent killer. More than 114 million adults in this country are at risk from damage caused by the long-term force of blood beating against artery walls, which often leads to disease and death. The good news is that hypertension is treatable and manageable through lifestyle changes and medications. Fact is, there are several approved blood pressure medications on the market, yet only about one in five people diagnosed with hypertension take medication. Why so few? Unfortunately, the side effects of these medications often outweigh the benefits. However, a new hypertension blockbuster may be imminent. A safer, better-tolerated drug candidate just marked a major milestone on the path to approval and commercialization. A global innovator in drug-delivery platforms, Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile) has been quietly progressing through clinical processes and amassing a growing body of evidence that strongly supports use of its patented DehydraTECH(TM) technology in hypertension therapeutics. The company’s valuation looks attractive with arguably significant upside as it looks to rub shoulders and gain attention from the likes of Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), AstraZeneca PLC (NASDAQ: AZN) and Novartis AG (NYSE: NVS) — all aiming to capitalize on what may be the next blockbuster and defend hundreds of millions from a silent killer.

• Globally, ReportLinker estimated the anti-hypertensive drugs market at $24.17 billion in 2020 on its way to reach $27.81 billion in 2025.
• About 114 million Americans have hypertension; in 2020 alone, more than 670,000 deaths in the United States had hypertension as a primary or contributing cause.
• Lexaria’s patented DehydraTECH technology improves the way active pharmaceutical ingredients enter the bloodstream, resulting in better uptake and lower dosage.
• Lexaria’s DehydraTECH hypertension study just marked a major milestone on the path to approval.

New Player in $24 Billion Market

Hypertension occurs when too much force pushes against the arteries that carry blood from the heart to the body. Most adults with hypertension in the United States are treated with recommended lifestyle modifications and prescribed medications, which include a wide spectrum of drugs, such as alpha-blockers, beta-blockers, diuretics, ACE inhibitors, ARB inhibitors and other options for resistant disease. In its 2021 industry report, ReportLinker estimated the global anti-hypertensive drugs market at $24.17 billion in 2020 on its way to reach $27.81 billion in 2025. All told, hypertension costs the country on average $131 billion annually, and even more sobering, in 2020 alone, more than 670,000 deaths in the United States had hypertension as a primary or contributing cause.

A recognized global innovator in drug delivery platforms, Lexaria Bioscience Corp. (NASDAQ: LEXX) is determined to fill the need for a safe, effective, tolerable treatment for hypertension and have a meaningful impact on comorbidity-related costs and deaths. Its patented flagship product, DehydraTECH, improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules. 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.

The science is somewhat complex, but the process to implement it is rather simple; the technology adds a couple of new steps in the formulation and manufacturing of existing or new oral and topical products. The process involves combining the API with select fatty acids, infusing the mixture into a substrate, and then using controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level, before integrating the newly combined molecules into end-product production across a range of dosage form factors.

Lexaria’s patent estate protecting its DehydraTECH IP is expansive, including 26 patents granted in the United States, Australia, the European Union, Japan, Mexico and India; the company also has roughly 50 additional patents pending.

The Evidence Speaks for Itself

DehydraTECH platform technology has a myriad of potential applications, and Lexaria is already gaining a reputation for being a recognized pioneer in innovative treatments. Various studies evaluating LEXX’s proprietary DehydraTECH platform have showed impressive results regarding delivery, with a 12-patient 2018 study showing 317% more substance delivered to the bloodstream at 30 minutes after ingestions and several studies in 2021 demonstrating efficacy specifically related to hypertension.

A 24-person study (HYPER-H21-1) evidenced rapid and sustained drop in blood pressure, especially systolic pressure and particularly in stage 2 hypertensive volunteers. A 16-person study (HYPER-H21-2) added to the data bank and a durable response, showing up to a 23% average reduction in overnight blood pressure and reduced arterial stiffness. That was followed by another 16-person study (HYPER-H21-3) demonstrating attenuated pulmonary artery systolic pressure by ~5 mmHg or 41% overall in male participants. All work supported a strong safety and tolerability profile for DehydraTECH treatment.

Closing In on IND

As it marches toward filing an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration, Lexaria launched its most comprehensive trial to date, HYPER-H21-4. A human clinical hypertension study, Lexaria just announced the next major step to approval: dosing has been completed in this study and no serious adverse events were reported as a result of the dosing.

The randomized, double blinded, placebo-controlled, cross-over study was designed to enroll a minimum of 60 patients. Dosing is now completed, meaning all patients at different times during the study have now received both the full dose regimen as well as the placebo. A total of 64 patients were dosed in this study, with maximum dose levels were up to roughly 5 mg/kg/day, which is significantly lower than maximum dose levels practiced for other similar regulator-approved pharmaceutical applications.

This is great news for Lexaria and for hypertension patients around the world as it’s strongly believed reduced dosing ameliorates unwanted side effects such as clinically significant elevated liver enzymes. “Demonstrating a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications is one of Lexaria’s major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations,” said Lexaria Bioscience Corp. CEO Chris Bunka.

The primary outcome is effect on 24-hour ambulatory blood pressure (a method of measuring blood pressure continuously). A variety of secondary outcomes are being evaluated, including vascular health; electrocardiogram analysis; brain structure and function through MRI testing; blood biomarkers; renal and hepatic analysis; sleep quality, daytime sleepiness and sleep disorders; actigraphy; geriatric depression scale; perceived stress; and Beck anxiety inventory.

The breadth of the secondary data could prove invaluable at identifying other benefits of the therapy, which dovetails perfectly with DehydaTECH being a true platform technology. These “other benefits” could even lead Lexaria to pursue additional FDA-regulated drug opportunities.

New Phase, More Value

As new drug development moves forward, valuations may climb into the hundreds of millions by phase 2 and billions of dollars in phase 3. “Biotech companies with little to no revenue can still be worth billions,” says hedge fund expert Raphael Rottgen, CFA. It’s essential to recognize that while valuations can be extremely low or extremely high, there is often underlying logic in identifying risks and arriving at those valuations.

Developing new drugs can have significant costs of more than $1 billion and can take years to reach the market. According to the US Food and Drug Administration (“FDA”), there are five steps to the drug development process:

1. Discovery and Development
2. Preclinical Research
3. Clinical Research
4. FDA Drug Review
5. FDA Post-Market Drug Safety Monitoring

Lexaria’s hypertension DehydraTECH program is currently in the range of both step 2 and 3, focusing on a mix of animal and human studies to evaluate tolerability, safety and efficacy. Certainly worth noting is that of the 5,000–10,000 compounds examined and tested in step 1, only about 250 successfully reach step 2, the preclinical research step; DehydraTECH-CBD has already reached and is surpassing this stage.

To lend additional color to valuations rising along with the FDA approval process, consider that Jazz Pharma paid $7.2 billion for GW Pharma after GW Pharma was successful in receiving FDA approval for Epidiolex, its proprietary treatment for pediatric seizure disorders. It’s also worth noting that in March, Pfizer paid $6.7 billion to acquire Arena Pharmaceuticals, a company with a diverse portfolio of drugs in clinical trials. Big pharma is clearly on the hunt for solutions.

Big Money in Heart, Blood Vessel Drugs

It’s no big secret that hypertension can lead to any number of life-threatening diseases, yet too many people overlook the condition. Hypertension usually starts with unhealthy lifestyles, frequently accompanied by obesity, so with 42% of the U.S adult population obese, there is no end in sight for hypertension and resultant co-morbidities. This a compelling dynamic for drug makers to keep searching for the next blockbuster hypertension drug.

Pfizer Inc. (NYSE: PFE) is going through a hiccup with its hypertension drugs at the moment, in March issuing a voluntary recall on several of its prescription blood pressure medications for elevated levels of nitrosamine, although the company had received no reports of anyone getting sick from the impurity. That said, Pfizer has been posting impressive quarterly results, bolstered by its COVID-19 vaccine and its antiviral treatment Paxlovid. Pfizer booked $9.9 billion in net income on a record $27.7 billion in revenue during Q2.

Merck & Company Inc. (NYSE: MRK) is looking to its spate of late-stage (and recently approved) cardiovascular medicines to provide growth going forward. As discussed at its Investor Day in April, Merck expects is medicines treating the heart and blood vessels to generate revenue in excess of $10 billion by the middle of the next decade.

AstraZeneca PLC (NASDAQ: AZN), the company that originally manufactured hypertension meds Inderal, Tenormin, Tenoretic, Zestril and Zestoretic, is committed to tackling hypertension and the increasing burden of cardiovascular disease through its Healthy Heart Africa Programme. The program launched in 2014 in Kenya, and has since spread to include Ethiopia, Tanzania, Ghana, Uganda, Côte d’Ivoire, Senegal and, in 2022, Nigeria. In 2020, AZN sold the global commercial rights to its hypertension meds to Atnahs Pharma.

Novartis AG (NYSE: NVS) has multiple blockbuster drugs, including its heart medicine, Entresto, a popular drug for hypertension. Last year, Entresto was approved for treating essential hypertension in China, where about 245 million people suffer from the condition. Sales of Entresto in the first half of 2022 were $2.2 billion, up 33% from the year prior period.

The World Health Organization estimates that 1.28 billion adults aged 30 to 79 have hypertension. That equates to a huge market opportunity for drug companies in the space, particularly those with differentiated approaches that could be extremely attractive to the majors looking for more market share and new platform technologies that can be expanded into other indications.

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

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