- Lexaria, a global innovator of drug delivery platforms is looking to provide a FDA registered hypertension treatment with its patented DehydraTECH technology
- The company’s efforts are encapsulated in its DehydraTECH-CBD that has been shown to lower blood pressure as well as reduce arterial stiffness
- Although hypertension is a devastating condition that can cause not only life-threatening illnesses but also death, only about 53% of Americans with the condition have it under control
- A Harvard Health article notes that the remaining portion (47%) are not able to control the disease because they are discouraged by medications’ side effects
- Lexaria’s DehydraTECH-CBD may well be the solution such individuals seek, but for now, the company is following the regulatory pathway to eventual drug approval
Hypertension causes life-threatening conditions such as stroke, heart attacks, coronary artery disease, and heart failure. But even more concerning, the condition leads to death. In 2020, the U.S. Center for Disease Control (“CDC”) reported that high blood pressure claimed more than 670,000 lives in the U.S. (https://ibn.fm/TI3fx). Globally, hypertension claims an estimated 7.5 million lives annually, according to the World Health Organization (“WHO”) (https://ibn.fm/3yda2).
Despite these devastating consequences and statistics, only about half (53%) of Americans living with high blood pressure have it under control, a problem that a Harvard Health article attributes to, among other common reasons, the fact that many stop taking their medication citing side effects (https://ibn.fm/ScKA6).
As a result, scientists and researchers have continuously explored ways to increase the chances of success as regards having the condition under control. One such study, a clinical trial, employed “a new strategy where patients are started on a pill containing four medicines, each at a quarter of their usual doses. [The strategy] has been shown to be much more effective in getting blood pressure under control, compared to the common practice of monotherapy, where treatment commences with just one drug” (https://ibn.fm/CbeZQ).
For researchers and scientists at Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, their quest takes a different approach that combines the effectiveness of the company’s proprietary DehydraTECH(TM) drug delivery technology and the emerging benefits of cannabidiol (“CBD”), one of which is the substance’s ability to slow down the heart rate and blood pressure, particularly in stressful situations (https://ibn.fm/uDCGb). In the latest tests, DehydraTECH-CBD has undergone human evaluations, yielding promising results.
CBD lowers systolic blood pressure in isolation (https://ibn.fm/U9xBC). However, with the addition of DehydraTECH, its capability and performance are boosted even further (https://ibn.fm/FZDkU). This is chiefly because DehydraTECH increases CBD’s bioavailability, a term that refers to the percentage of a drug that enters the bloodstream and becomes available to the intended biological target. In its first human study, conducted in 2018 and involving 12 patients, Lexaria showed that DehydraTECH delivered 317% more CBD to the bloodstream 30 minutes after ingestion (https://ibn.fm/gNDcX).
Since then, the company has undertaken a series of other human studies. 2021, in particular, saw the company complete three studies: HYPER-H21-1, HYPER-H21-2, and HYPER-H21-3. The first study evidenced a rapid and sustained decrease in blood pressure, particularly systolic pressure. The second study showed that DehydraTECH-CBD caused a 23% average reduction in overnight blood pressure in addition to reducing arterial stiffness. The third revealed that the substance caused a 41% overall attenuation in pulmonary artery systolic pressure among male participants.
Its fourth study, HYPER-H21-4, is its most comprehensive yet. With dosing having been completed in late July, Lexaria announced that no serious adverse events were reported. “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 authorization,” Lexaria CEO Chris Bunka said of the HYPER-H21-4 study (https://ibn.fm/BHKt1).
The company looks to leverage the results of the fourth study to file an Investigational New Drug (“IND”) application seeking the U.S. Food and Drug Administration (“FDA”)’s approval to begin registered clinical testing at Phase I level or higher. The study, Lexaria observes, is designed to boost the company’s probability of success with the application.
And as analysis contained in an August 11 press release shows, the commencement of Phase I (or even higher) studies, as and when it happens, could portend good tidings for the company’s investors. According to a valuation guide authored by Bay Bridge Bio, the potential valuation of a company increases as a company’s clinical trials move from Phase I through Phase III. Accordingly, Lexaria’s valuation may trend upward with time (https://ibn.fm/7kBHk).
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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