- Lexaria has received approval from the Independent Review Board for its DehydraTECH-CBD Human Clinical HYPER-H21-4 study
- The approval signals the company has taken the appropriate steps to protect the rights and welfare of human subjects participating in its fourth human study
- HYPER-H21-4 should “de-risk” outcomes prior to Lexaria’s planned entry into regulatory pathways for the use of DehydraTECH-CBD to treat hypertension and perhaps other forms of cardiovascular disease
- Previous studies – HYPER-H21-1 and HYPER-H21-2 – have evidenced a remarkable, rapid, and safe drop in blood pressure with DehydraTECH-CBD
A little less than two months after Lexaria Bioscience (NASDAQ: LEXX) announced it was readying the study protocols for HYPER-H21-4, its most ambitious and comprehensive study yet, for submission to the Independent Review Board (“IRB”) with approval anticipated by January 2022 (https://ibn.fm/DASCc), the company is celebrating the receipt of the approval ahead of schedule.
An administrative body created to safeguard the rights and welfare of human subjects recruited to participate in research activities, the IRB is tasked with approving, disapproving, monitoring, and requiring modifications to studies and their respective protocols (https://ibn.fm/IVBB0).
The IRB approval signals Lexaria has taken the appropriate steps to protect the rights and welfare of human subjects participating in its HYPER-H21-4 study, Lexaria’s fourth human clinical study evaluating DehydraTECH-CBD as a potential treatment for hypertension and perhaps other forms of cardiovascular disease. In total, the study is expected to comprise 60 volunteers aged between 45 and 70 years (https://ibn.fm/Y9p0I).
As part of the research, which will utilize a double-blinded, randomized cross-over design, and placebo control, a subset of the volunteers will already be using the leading standard of care hypertension drugs such as ACE inhibitors with or without diuretics. The rest will use three 150 mg doses of DehydraTECH-CBD daily for six weeks, the duration of the study. Dosing is tentatively set to begin by April 2022.
Results from study HYPER-H21-4 are expected to add to Lexaria’s growing body of evidence for the effectiveness of DehydraTECH-CBD against hypertension. In addition, it will explore the potential for longer term health benefits that might otherwise remain undetected, with the 6-week duration of the study enabling the company to gather critical data monitoring of DehydraTECH-CBD over time.
HYPER-H21-4 will involve multiple types of analysis, including 24-hour ambulatory blood pressure (the primary outcome); arterial stiffness and autonomic balance; brain structure and function through brain MRI; blood markers; renal, hepatic, sleep quality/daytime sleepiness/sleep disorders; actigraphy, geriatric depression scale, perceived stress, and back anxiety inventory.
The enormous volumes of data from the study, if positive, should support the company’s plans to enter regulatory pathways expected to eventually result in regulatory approval to use DehydraTECH-CBD as a treatment for hypertension and possibly other types of cardiovascular disease.
Already, Lexaria’s previous human studies, HYPER-H21-1 and HYPER-H21-2, have evidenced a remarkably rapid, and safe drop in blood pressure with DehydraTECH-CBD. Furthermore, according to an announcement issued last month, the HYPER-H21-3, also regarded as a ‘stress test’ study, was conducted to examine DehydraTECH-CBD’s effects on pulmonary vascular function in normotensive individuals exposed to hypoxia (oxygen tension). This third study will fill a knowledge gap that existed as regards the extent to which CBD may act as a novel treatment for hypoxic pulmonary vasoconstriction (“HPV”) and as a potential alternative treatment for pulmonary hypertension.
Currently valued at an estimated $28 billion, the antihypertensive drug market is expected to continue growing (https://ibn.fm/W39lb). However, with less than 25% of persons with hypertension having successfully controlled their condition using medication, Lexaria notes the potential market for hypertension drugs would be much greater than the estimated figure if an affordable drug with few or no side effects were available.
“Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable antihypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects,” reads the December 29 news release reporting the receipt of the IRB approval.
A global leader in enhancing the speed and efficiency of orally-delivered fat-soluble active molecules and drugs, Lexaria has developed DehydraTECH, a patented technology that improves the bioavailability of pharmaceuticals and therapeutics. The technology combines active pharmaceutical ingredients (“API”), such as cannabidiol (“CBD”), with the product achieving fast onset, increased bioavailability, and improved effectiveness, according to subjective and objective clinical testing.
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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