NetworkNewsWire Editorial Coverage: A leading cause of death in the United States for men and women of most racial and ethnic groups, heart disease is a pervasive health challenge that destroys lives. The Centers for Disease Control and Prevention (“CDC”) reports that one person dies every 36 seconds from cardiovascular disease. Treating the disease, as well as the conditions related to it such as high blood pressure, or hypertension, is a top priority for those in the medical space, and innovative companies are looking for ways to provide even more effective treatments. A leader in hypertension innovation, Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile) is focused on using its patented DehydraTECH(TM) drug delivery to identify safe and affordable treatments to the approximately 108 million, or almost one-half, of American adults dealing with high blood pressure. Innovation is a key characteristic of any successful company working in the pharma space, and other companies that are recognized as innovation leaders include Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Johnson & Johnson (NYSE: JNJ), United Therapeutics Corporation (NASDAQ: UTHR) and Abbott Laboratories (NYSE: ABT).
- Hypertension is a primary risk factor for heart disease, a leading cause of death in the United States.
- Lexaria is an innovator in the space, developing potential treatments utilizing its proprietary DehydraTECH technology.
- LEXX has identified three main areas to focus on, including pharmaceuticals and the treatment of heart disease.
- Early reports from the company’s most recent human clinical study show DehydraTECH technology demonstrated rapid, sustained drop in blood pressure.
Hypertension News Isn’t All Bad
While the CDC reports that nearly half of all adults in the United States, or 108 million, have hypertension, only about 24% of those have their condition under control. In fact, many don’t even know they have it. Yet controlling blood pressure is critical to good health.
High blood pressure is often a primary or cause of death in almost 500,000 deaths a year, with hypertension potentially doubling the risk of a heart attack and quadrupling the chance of having a stroke; the condition can also increase the chances of heart failure, vision loss, renal disease, dementia, peripheral artery disease and more. And it’s not just a problem for “old-people”; nearly one in four adults between the ages of 20 to 44 have high blood pressure. In addition, high blood pressure costs the United States about $131 billion each year.
But the news isn’t all bad. Hypertension can be managed — and even cured — with proper diagnosis and treatment. It should come as no surprise then that the global anti-hypertensive drug market is projected to grow from $24.17 billion in 2020 to $27.81 billion in 2025. Even with current hypertension drugs available, only 24% of the 108 million people in the U.S. with high blood pressure have their condition under control. It’s a market ripe for innovation.
Drug-Delivery Platform Shows Exciting Potential
Lexaria Bioscience Corp. (NASDAQ: LEXX) looks to be a leader in some of the most exciting innovation happening in the treatment of high blood pressure. The Kelowna, British Columbia-based company has identified, developed and patented a new drug-delivery platform. The proprietary tech, called DehydraTECH technology, has been proven to increase the speed of onset, bioavailability and potency of a variety of substances.
The mechanics involve combining an active pharmaceutical ingredient (“API”) with fatty acid oil and then applying the mix to carrier particles, which can be common ingredients such as tapioca starch or gum arabic. Next, a patented dehydration synthesis procedure is completed, resulting in a powder or liquid that can be used in the desired final form factor, such as a pill, tablet, chewable or oil.
Recognizing the potential for this new innovation, Lexaria has worked with National Research Council of Canada, the biggest R&D organization in the country, since 2017. The partnership has focused on defining the qualities of DehydraTECH, including that Nuclear Magnetic Resonance molecular characterization suggests DehydraTECH does not change the chemical structure of an API it delivers. This is essential when considering reliance on original API safety data in developing novel delivery methods without starting from scratch regarding the FDA process, which opens the door to a faster path to market.
Bottom line, this means that DehydraTECH could make lower doses of some substances more effective while potentially reducing side effects. With this in mind, the company has identified three areas in which to focus ongoing research and development; one of those areas is pharmaceuticals and the treatment of heart disease.
Early Study Results Confirm DehydraTECH Promise
As part of that R&D, Lexaria recently released results from a human clinical study using DehydraTECH technology that indicated a rapid and sustained drop in blood pressure along with excellent tolerability. “We are very encouraged by these early results in our 2021 hypertension program,” said Lexaria CEO Chris Bunka. “Lexaria’s technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in stage 2 hypertensive volunteers.”
The early report noted that initial study results show a reduction in blood pressure in both male and female volunteers; the decrease was most pronounced in the first 10–50 minutes of the study treatment, reinforcing pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic controls. Lead investigator on the study Dr. Phil Ainslie reported that “these early results are extremely promising in this at-risk hypertensive population and provide a fundamental support for expansion into more prolonged repeat dosing and future longer term clinical trials.
Diversification Creates Widespread Interest
In addition to its work on heart disease and hypertension, Lexaria is also studying the potential impact DehydraTECH might have on reduced-risk noncombusted nicotine and improved antiviral drug delivery. Several successes in the company’s diverse pipeline have been reported, in including in the antiviral program where DehydraTECH was used to process compounds from leading drugs used for antiviral drugs for SARS-CoV-2/COVID-19 and HIV/AIDS. This work holds particular promise in the current treatment of COVID-19 as well as looking forward and being better prepared in the future for future, inevitable pandemic situations.
The potential for use in a diverse group of market opportunities could create widespread interest in DehydraTECH possibilities. An example is today’s antivirals market, particularly the COVID-19 pandemic and the circulating delta variant; the market is currently estimated at $52.1 billion with projections to reach $66.7 billion by 2025. And that is only the beginning; DehydraTECH’s versatility points to many other potential applications, including human hormones (e.g., testosterone and estrogen replacement, a $21.9 billion market); oral mucosal nicotine (global smokeless tobacco products market valued at $13.6 billion in 2018), vitamin D3 ($1.1 billion market); PDE5 inhibitors ($4.4 billion market in 2014); and non-steroidal anti-inflammatories ($15.6 billion market in 2019).
Success Follows Innovation in Pharma Space
Lexaria is leading the way in hypertension innovation, where research and discovery could not only save lives but also deliver significant profits. The $92.4 billion cardiovascular drug market generates billions of dollars every year for successful drug makers. Other big pharma companies are looking to innovate in other promising markets as well.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) recently announced the Health Canada approval and availability of Vyxeos(R) for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. A cancer of the bone marrow and blood, Considered a rare disease, AML affects approximately 1,100 men and women in Canada annually, and though the number of AML cases continues to rise, current treatment regimens have remained the same for decades until now. “As a company dedicated to bringing life-changing medicines to market and redefining possibilities, the approval of Vyxeos in Canada represents Jazz’s promise of putting patients first,” said Paul Petrelli, general manager of Jazz Pharmaceuticals Canada Inc.
Johnson and Johnson Innovation, a division of Johnson & Johnson (NYSE: JNJ) dedicated to innovating in the medical space, recently announced the extension of the Johnson & Johnson Innovation Partnering Office. The office is located at Monash University’s Clayton Campus in Melbourne and works in collaboration with the Victorian state government. This joint initiative between Johnson & Johnson Innovation, the Victorian Government and Monash University will be extended for approximately two years through June 30, 2023. The agreement will allow the group to continue connecting with the Victorian innovation ecosystem, nurturing and accelerating innovative research, new product development and commercialization for a global market.
United Therapeutics Corporation (NASDAQ: UTHR) announced in June that the U.S. Food and Drug Administration (“FDA”) has accepted for priority review its New Drug Application (“NDA”) for Tyvaso DPI(TM) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Tyvaso DPI is a next-generation, dry-powder formulation of Tyvaso. If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy.
Abbott (NYSE: ABT) received clearance this week from the FDA for its latest optical coherence tomography (“OCT”) imaging platform powered by the company’s new Ultreon software. This innovative imaging software combines OCT with artificial intelligence (“AI”) to provide physicians an enhanced, comprehensive view of coronary blood flow and blockages to assist physician decision-making and provide the best pathway for treatment. The company’s Ultreon software integrates with Abbott’s new Dragonfly OpStar imaging catheter and PressureWire X guidewire to provide physicians access to a broad set of tools to assess coronary blood flow and blockages and improve treatment planning for patients.
Innovation — in the high blood pressure space as well as other compelling sectors in the pharma world — has the potential to deliver huge dividends. Most important, of course, is lives that are literally saved and quality of life that is enhanced, but triumph in billion-dollar markets can provide added incentive for success.
For more information about Lexaria Bioscience Corp., please visit Lexaria Bioscience Corp.
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