NetworkNewsWire Editorial Coverage: Hypertension, or high blood pressure, is rampant in America. An estimated 45% of adults in the United States, or 108 million people, have hypertension, yet only about one out of every four have their condition under control. That’s a big problem considering hypertension increases risks for heart disease and stroke, which are, respectively, the no. 1 and no. 5 leading causes of death in the nation each year. To that point, the CDC names hypertension as a primary or contributing cause in nearly half a million deaths annually in the U.S. Hypertension treatment options vary tremendously from meditation to conventional drugs, with what looks to be a promising new innovation on the horizon from Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile). Lexaria is proving that its proprietary DehydraTECH(TM) technology repeatedly delivers strong therapeutic responses, without the side effects of today’s drugs. Lexaria is looking to throw its hat into the ring with majors in the market today that are making billions of dollars by treating high blood pressure and other leading causes of death, including Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), AstraZeneca PLC (NASDAQ: AZN) and Moderna Inc. (NASDAQ: MRNA).
- The global anti-hypertensive market size is $24.4 billion currently and expected to reach $27.8 billion in 2025, yet only 24% of patients control their disease.
- Lexaria Bioscience is using its patented DehydraTECH technology to develop highly effective treatments for hypertension and other disorders.
- Multiple lab studies and three human clinical trials show the efficacy of LEXX’s exclusive DehydraTECH treatment.
- Lexaria has now initiated IND-enabling studies and is considering an FDA 505(b)(2) accelerated development pathway.
Click here to view the custom infographic of the Lexaria Bioscience Corp. editorial.
Move Over Blockers and Diuretics, DehydraTECH Is Here
Alpha blockers, beta blockers, diuretics, ACE inhibitors — the list goes on and on for different classes of drugs designed to keep blood pressure in a normal range so the excessive pressure on artery walls doesn’t lead to organ damage. Yet only 24% of those suffering from hypertension have their blood pressure under control, which speaks loudly to the market opportunity at hand. Perhaps side effects associated with current treatments are the culprit.
Yet the market is certainly worth entering. Consider that Reportlinker.com estimates the global anti-hypertensive drugs market to be $24.37 billion in 2021 and growing 3.4% annually to $27.81 billion in 2025. That’s a nearly $28 billion market where only one patient in four is treating the disease. How big would that market be if the other three in four patients found a drug they would consent to use?
Lexaria Bioscience Corp. (NASDAQ: LEXX) may have a market cap of only around $35 million, but it is an emerging technological leader pursuing more effective delivery systems for the potential treatment of hypertension. Lexaria has commercialized its unique and powerful drug delivery technology, branded DehydraTECH, which has been both laboratory and market proven to enhance the performance of several categories of fat-soluble active molecules and drugs, across oral and/or topical product formats.
Lexaria has already received granted patents in the Unites States, Japan, India, the European Union and Australia for DehydraTECH, and specific patents for using DehydraTECH to treat heart disease in both the European Union and Australia. Lexaria is working its way through all-important clinical research evaluating its proprietary DehydraTECH-processed treatments for dosing, safety and performance factors. Clinical research to date has produced what appear to be amazing results. This is critical work insomuch that not only does it show superiority to any potential direct competition that could crop up, it also evidences the power of the DehydraTECH technology as a drug delivery platform.
First Clinical Trial, Two Lab Studies Set Stage
In September 2019, results from Lexaria’s first clinical trial were peer reviewed and published on the National Institute of Health’s PubMed.gov website. Using a double-blind, placebo-controlled format, the study concluded that Lexaria’s proprietary DehydraTECH approach was associated with an increase in cerebral perfusion and reduction in blood pressure compared with baseline and the 90 mg control. The data were the building blocks for Lexaria’s ongoing work to develop its innovative hypertension drug.
In 2021, Lexaria ramped up its research, including studies evaluating DeyhydraTECH 2.0 formulations delivery performance enhancements and pharmacokinetic optimization. The R&D did not disappoint with the animal study HYPER-A21-1 showing DehydraTECH 2.0 delivering up to 2,178% more targeted substance into the bloodstream and 1,737% more to brain tissue than the standard medium chain triglyceride (“MCT”) oil-based control formulation representative of standard industry practices.
A second applied research and development study program this year, HYPER-A21-2, delivered the highest payload yet of 2,708% more substance treatment into bloodstream than the control. The foundation was set for clinical trials.
Clinical Data
Late in July, initial data from Lexaria’s human clinical study HYPER-H21-1 evidenced a rapid and sustained drop in blood pressure (“BP”) with its DehydraTECH treatment, along with excellent tolerability. BP was reduced across both male and female volunteers and was most pronounced in the first 10 to 50 minutes of the study, which dovetailed perfectly with previous research of superior performance over generic controls.
The study’s lead investigator Dr. Phil Ainslie, a professor at the School of Health and Exercise Sciences and co-director of the Centre for Heart, Lung & Vascular Health at the University of British Columbia Okanagan, summed the initial results up succinctly in saying, “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.”
In a second human clinical study, HYPER-H21-2, initial results related to BP again were positive, showing up to a notable 23% decrease in blood pressure with LEXX’s patented DehydraTECH technology relative to placebo in volunteers with mild to moderate hypertension. This is competitive with or exceeding the results of most other hypertension drugs. In aggregate, the data was once again impressive across the board showing a meaningful therapeutic effect to reduce BP compared to controls.
The partial results even indicated that Lexaria’s DehydraTECH approach triggered its most significant effects during the overnight period during sleep and early in the morning. This is an important discovery since these periods are notoriously associated with cardiac stress and heart attacks when a hypertensive patient rises/becomes active after sleeping.
Next Steps: IND, NDA
While investors and the company await complete BP subset analyses from both clinical trials, Lexaria is moving ahead with a milestone in drug development by formally beginning the process towards an Investigational New Drug (“IND”) application filing with the Food and Drug Administration to advance its exclusive hypertension treatment technology.
The IND-enabling program is supported with animal studies, human studies and work conducted in collaboration with Canada’s National Research Council that demonstrate the DehydraTECH treatment to have superior bioabsorption upon oral administration and is effective at reducing blood pressure with no significant unwanted side effects. Lexaria is also considering the possibility of pursuing an FDA 505(b)(2) pathway that significantly can shorten the time to filing a New Drug Application when/if applicable by leveraging known safety and Pharmacokinetic data of an active pharmaceutical ingredient.
Protecting the Heart Is Big Business
Hypertension may not sound very scary — perhaps because it’s so common. But say things like heart attack, stroke, heart failure, or kidney disease, common diseases associated with hypertension; and the mood may change. Doctors realize the serious nature of it and so do drugmakers. That may be why there are so many drugs on the market for all things hypertension related, many of which are blockbusters, generating more than a billion dollars in annual sales.
Pfizer Inc. (NYSE: PFE), a global drug-making juggernaut, has long been a leader in solutions for cardiovascular disease (“CVD”). The company notes that an aging population and rising rates of other diseases increase CVD risks underscores expectations for rising prevalence of CVD. The company’s pipeline shows a bevy of drugs in various stages of development for hypertension and related diseases, including diabetes and obesity.
Merck & Company Inc. (NYSE: MRK), which generated $11.4 billion in second-quarter sales, is probably best known for cancer drugs but is a stalwart in the hypertension drug space too. The company’s product catalog contains adrenergic modifiers, ACE inhibitors, ARBs, beta blockers, calcium channel blockers, direct vasodilators and much more addressing the condition. In a similar lane, the FDA earlier this year granted approval to Merck and Bayer’s Verquvo (vericiguat) as indicated for heart failure.
AstraZeneca PLC (NASDAQ: AZN) has one of the richest clinical pipelines today in the heart failure area in terms of prevention and treatment of various subtypes of heart failure. AstraZeneca takes a holistic approach, recognizing multiple risk factors and comorbidities across cardiovascular, renal, metabolic diseases (“CVRM”) in a bid to reduce the risk of heart failure. The AZN pipeline is full of mid-late stage drug candidates for cardiovascular and kidney diseases.
Moderna Inc. (NASDAQ: MRNA) seems to be constantly in the news lately for its COVID-19 vaccine, which is undoubtedly great for revenue. The Massachusetts-based company is more than just an coronavirus vaccine company, however; it has mRNA candidates in clinical development across five therapeutic areas: infectious disease, cardiovascular, oncology, rare disease and autoimmune disorders, including a Phase 2 localized regenerative therapeutics VEGF-A program for myocardial ischemia.
There are many ways for investors to gain exposure to cardiovascular diseases and conditions, some of which aren’t so obvious while casually raking in billions of dollars in annual sales. It can be a numbers game, and when more than 50 million people worldwide are at risk, it’s wise to take a closer look at where the winners may be lurking.
For more information about Lexaria Bioscience Corp., please visit Lexaria Bioscience Corp.
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