- Lexaria is a drug delivery technology company developing DehydraTECH-CBD as a prospective registered treatment for hypertension and potentially other disease states beyond hypertension
- The company has undertaken multiple de-risking hypertension studies that have not only evidenced that DehydraTECH-CBD is safe and well tolerated, but have also shown that it reduces blood pressure and arterial stiffness
- Hypertension is a leading contributor to deaths in the United States, damaging organs such as the heart, brain, and kidneys, yet only a tiny proportion of patients have it under control
Hypertension, an area of interest and focus for drug delivery technology company Lexaria Bioscience (NASDAQ: LEXX), has many harmful effects on the body, its organs, and overall personal health. Hypertension, or high blood pressure is a condition characterized by consistent exertion of elevated pressure – at least 130/80 mmHg – on blood vessels. This pressure, analyses have shown, causes the walls of blood vessels to become less stretchy or elastic, narrowing their internal cross-sectional area and ultimately damaging them (https://ibn.fm/UJNJ5).
As a result, blood flow drastically reduces, and in a cascade of events, the flow of oxygen to the heart also declines. This has been linked to heart disease, heart attack, and heart failure. Nonetheless, the reduced blood flow does not only impact the functionality of the heart but also other organs, including the brain and kidneys. In fact, high BP is the second leading cause of kidney failure in the United States (https://ibn.fm/bPzVK).
Despite their relatively small size, kidneys serve as the body’s filtration system – they remove toxins, extra fluid, and waste from the blood through filtering units known as nephrons. The narrowing of blood vessels due to hypertension, however, deprives the nephrons of oxygen and other essential nutrients, impeding their normal function. This causes excess build-up of fluid and waste in the blood, which can, in turn, elevate the blood pressure even further. At the same time, kidneys also regulate blood pressure by responding to the hormone aldosterone. Therefore, they trigger a further elevation in blood pressure if and when they cannot function well due to the above events.
The various effects of hypertension point to the importance of keeping the condition under control. And although it can even lead to death and is, in fact, one of the leading causes of death in the United States, awareness, diagnosis, and management are still considerably low. According to the World Health Organization (“WHO”), about 46% of adults with hypertension are unaware they have the condition. At the same time, only about 42% of adults with high BP are diagnosed and treated, while only 21% of hypertensive adults have the condition under control (https://ibn.fm/7HhB6).
These statistics are worrying in light of the myriad consequences of high blood pressure, which is why Lexaria has focused its attention on finding a safe and effective treatment. The company, which created a patented drug delivery technology called DehydraTECH that can be applied in broad use within the pharmaceutical industry, is positioning DehydraTECH-processed cannabidiol (“CBD”) as a potential treatment for hypertension.
“Our biggest area of investigation in 2021 was CBD for hypertension and heart disease, and we enjoyed a very successful year in this regard,” wrote Lexaria CEO Chris Bunka in his 2022 letter to shareholders (https://ibn.fm/NOsVd). “This year , we evidenced that human blood pressure dropped within minutes of swallowing DehydraTECH-CBD capsules, after just a single dose… At selected times during the 24-hour [HYPER-H21-2 follow-up] study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo. This is a large response after a single day of dosing, and we were encouraged by these results.”
In total, the company conducted three de-risking studies in 2021, with the third, HYPER-H21-3, showing that DehydraTECH-CBD reduced pulmonary systolic pressure by ~5 mmHg or 41% overall in male participants. Throughout all three studies, Lexaria evidenced no significant adverse effects with DehydraTECH-CBD.
In July this year, Lexaria completed dosing for its largest hypertension study yet, HYPER-H21-4, reporting no serious adverse events (https://ibn.fm/pNtoa). Sixty-six patients were dosed in the study over five weeks, conforming to the company’s initial desire to evaluate a “large enough group to obtain reliable, statistically significant data and a long enough study duration to witness the true power of DehydraTECH-CBD in modulating BP.”
“If this study is successful, we feel strongly that it will be highly supportive of our Investigational New Drug (“IND”) filing plan, and we will have a clear path toward designs of Phase I and even potentially Phase II FDA-registered clinical studies thereunder,” Bunka continued. Lexaria expects to release the results in due course.
By developing DehydraTECH-CBD as a prospective registered treatment for hypertension and potentially other disease states beyond hypertension, Lexaria hopes to provide hypertensive patients with safe, well-tolerated, and effective medication to help them manage their condition, consequently preventing adverse effects such as kidney disease.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX
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