- Lexaria has embarked on its HYPER-H21-4 study, its fourth hypertension clinical study, and it’s most ambitious yet
- This study builds on the HYPER-H21-1 and HYPER-H21-2 findings, as well as the HYPER-H21-3 study that is set to begin dosing in mid-November 2021
- Lexaria’s goal is to pursue regulatory approval for its proprietary DehydraTECH-CBD for potential use as a treatment for high blood pressure
- Study protocols are being readied for submission to the IRB, and approval is expected by January 2022
Lexaria Bioscience (NASDAQ: LEXX) has, so far in 2021, embarked on several studies geared towards evaluating its proprietary DehydraTECH(TM) CBD for the potential treatment of hypertension and heart disease.
Results from the first hypertension study, HYPER-H21-1, were released on July 29, 2021, showing that the administration of a single dose of 300 mg of DehydraTECH-CBD resulted in a significant reduction in blood pressure from baseline. Of the 24 adult volunteers in the study, those who were Stage 2 hypertensive, peak systolic blood pressure reductions from baseline were observed of as much as approximately 13 mmHg by the 50-minute time point with DehydraTECH-CBD. Additionally, systolic blood pressure remained depressed throughout almost the entire 3-hour duration of the study (https://ibn.fm/DENxV).
The second study of the year, HYPER-H21-2, also yielded more impressive results. Again, 16 adult volunteers took part in the study, which involved taking three doses of 150 mg each of DehydraTECH-CBD, with results measured over a 24-hr ambulatory period. At selected times during the study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg decrease in blood pressure, relative to placebo, coupled with an average 7% reduction in systolic pressure.
The learnings from these two studies have led up to the HYPER-H21-4 clinical study, Lexaria’s most ambitious one thus far. It is expected to involve 60 different volunteers aged between 45 and 70 years. Each of them will use three 150 mg doses of DehydraTECH-CBD every day over six weeks.
“HYPER-H21-4 is the most ambitious study Lexaria has ever undertaken and is enabled from the successful outcomes from our other 2021 human hypertension studies,” noted Chris Bunka, Lexaria’s Chief Executive Officer (“CEO”).
This study will use a double-blinded, randomized cross-over design while also utilizing a placebo control. A specific group of volunteers will already be using leading standard care hypertension drugs to evaluate the efficacy of the patented DehydraTECH technology, particularly, DehydraTECH-CBD with and without other hypertension treatments.
The HYPER-H21-4 study will be more comprehensive than Lexaria’s previous studies. The eventual goal is to seek regulatory approvals for DehydraTECH-CBD for potential use as a treatment for high blood pressure, and data from this study could be instrumental in that pursuit. Different types of analysis will be conducted, from 24-hour ambulatory blood pressure to autonomic balance and arterial stiffness, brain structure and function through magnetic resonance imaging and blood biomarkers including lipids such as cholesterol and more.
Study protocols for this study are being readied for submission to the Independent Review Board (“IRB”), and approval is expected by January 2022.
In the meantime, Lexaria has completed DehydraTECH-CBD manufacturing for the HYPER-H21-3 study. Clinical test articles have also been delivered to the study location. Dosing is set to begin in mid-November or thereabouts and will be completed by mid-December. Blood pressure findings will be reportable by the end of January 2022 and will contribute to the HYPER-H21-4 study as well.
Today, about 1.28 billion people suffer from hypertension, making it one of the world’s top health problems. Of these, only 21% of them have the condition under control, a statistic that demonstrates an enormous unmet need (https://ibn.fm/jUP1F). The hypertension treatment market is valued at USD$28 billion per year, and it is projected that in 2022, the broader cardiovascular disease category, under which hypertension falls, will be valued at USD$146 billion (https://ibn.fm/zVMT9).
Lexaria understands the high unmet need for hypertension and cardiovascular diseases in general, hence its investment into its DehydraTECH research and the development of its proprietary DehydraTECH-CBD. With the HYPER-H21-4 study, the company is inching ever closer to regulatory approval, which would allow it to tap into this lucrative market and offer relief to billions of people living with cardiovascular diseases today.
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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