- Lexaria Bioscience, a global innovator in drug delivery technology, has developed a potential treatment for hypertension using the company’s patented DehydraTECH(TM) platform, now shown in several human studies to reduce blood pressure and arterial stiffness
- Lexaria’s antihypertensive drug development program comes at a time when researchers are documenting poor control of hypertension among both men and women, partly due to suboptimal adherence to existing antihypertension medication
- Reasons advanced for the suboptimal adherence include lack of awareness or treatment, increased number of prescribed medications, and major adverse effects of the prescribed drugs
- Lexaria has so far shown that its DehydraTECH-CBD is not only effective but also well tolerated and is planning to undertake registered clinical trials in pursuit of the FDA’s approval of the drug candidate
A recent research article published in the Journal of the American Heart Association (“AHA”) unearths data that suggests poorly controlled hypertension among both men and women (https://ibn.fm/oy2TN), a problem global innovator Lexaria Bioscience (NASDAQ: LEXX) is keen on solving.
The researchers, who sought to describe gender-differential disease patterns and results of more than 20.6 million emergency department encounters in the United States from 2016 to 2018, made several observations. Firstly, most ED cardiovascular (“CVD”) visits in the sample were due to hypertensive diseases. Secondly, essential hypertension, which is high blood pressure not resulting from other maladies, was the most common CVD diagnosis in women and second most common in men (https://ibn.fm/2b9jQ).
Moreover, the article notes, “Attendances for essential hypertension were more common in women, which may reflect higher rate of preexisting hypertension in women (76.6% vs. 74.4%). These findings may also reflect poorer control of hypertension or poorer access to primary care in women… Further supporting these suppositions, in our sample, although men were less likely to present to the ED with essential hypertension, they were slightly more likely to present with long-term consequences of hypertension-related end-organ damage (hypertensive heart or kidney disease) and were more likely to die following such presentations, suggesting longer duration of exposure to poorly controlled hypertension than women.”
This recent study is one of the latest in a series of research works on uncontrolled hypertension that date back to the 20th century. In a scholarly article published in 2005 in the AHA Journal, for example, researchers observed a high prevalence of uncontrolled hypertension that suggested a significant number of CVD events could be prevented by improved blood pressure control.
“The benefits of pharmacological treatment for [hypertensive] patients are well established. Meta-analysis of randomized placebo-controlled trials indicate that antihypertensive therapy reduces the risk of stroke by approximately 30%, coronary heart disease by 10-20%, congestive heart failure by 40-50%, and total mortality by 10%,” the 2005 research article continues (https://ibn.fm/9WAMD).
Several other studies have put forth reasons that are thought to cause suboptimal adherence, leading to poor control. These reasons include the lack of awareness or treatment, an increased number of antihypertensive drugs, and major adverse effects, just to mention a few (https://ibn.fm/46bPk). As this happens, hypertension remains the leading cause of noncommunicable disease deaths globally, raising concerns that have caught the attention of Lexaria, a company developing a potential hypertension treatment with little to no side effects.
The treatment is created by processing cannabidiol (“CBD”) using the company’s patented DehydraTECH(TM) drug delivery technology, which has been shown to substantially increase the bioavailability of active pharmaceutical ingredients (“APIs”). In human studies, Lexaria has shown that DehydraTECH-CBD not only increases the amount of CBD in the blood by as much as 317% but also reduces blood pressure and arterial stiffness.
To put these findings into a more comprehensive context, the company’s 24-person human clinical study, christened HYPER-H21-1, evidenced a rapid and sustained drop in blood pressure. The second study, HYPER-H21-2, a 16-person HCS, showed up to a 23% reduction in overnight blood pressure as well as reduced arterial stiffness, while the third study, HYPER-H21-3, evidenced attenuated pulmonary artery systolic pressure. What the three studies had in common was that no serious adverse events were reported, suggesting that DehydraTECH-CBD is well tolerated (https://ibn.fm/BZWuX).
To further confirm this fact, Lexaria is working toward a planned Phase I(b) trial, expected to commence following the filing of an Investigational New Drug (“IND”) application and the fulfillment of other regulatory requirements. According to the company, the IND-enabling program is currently underway and is expected to be completed later this year or early next year (https://ibn.fm/dOnXv).
Lexaria hopes to prove, through registered clinical trials, that its DehydraTECH-CBD formulation has an acceptable safety and tolerability profile and that it is effective against hypertension. The proof could potentially influence the registration of DehydraTECH-CBD as the second FDA-approved CBD drug, offering a reprieve to millions of hypertension patients who do not have their condition under control because they receive numerous antihypertensive drugs or are unwilling to suffer through these medications’ adverse side effects.
For more information, visit the company’s website at www.LexariaBioscience.com.
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