Lexaria Bioscience Corp. LEXX LEXXW revealed that dosing with Lexaria's DehydraTECH-processed CBD has been completed in its multi-week human clinical hypertension study HYPER-H21-4, and that no serious adverse events have been reported as a result of the dosing.
HYPER-H21-4, is a randomized, double blinded, placebo-controlled, cross-over study that was designed to enroll a minimum of 60 patients. Dosing has now completed, meaning all patients at different times during the study have now received both the full DehydraTECH-CBD dose regimen as well as the placebo. A total of 64 patients were dosed in this study. Maximum dose levels were roughly 5 mg/kg/day which is significantly lower than maximum dose levels practiced for other regulator-approved pharmaceutical CBD applications.
"We are extremely pleased that dosing has been completed on time in this multi-week clinical study without any serious adverse events having occurred," stated Chris Bunka, CEO of Lexaria Bioscience Corp. "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 authorizations."
HYPER-H21-4 is designed to enhance Lexaria's probability of success toward an investigational new drug application filing to seek U.S. Food and Drug Administration approval to commence registered clinical testing at the phase I level or higher, to be determined in consultation with the FDA. This human study is also expected to enhance Lexaria's understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension related to increased arterial stiffness and blood biochemistry, pursuant to earlier promising findings in this area.
Study details & secondary study outcomes
HYPER-H21-4 consisted of male and female volunteers between the ages of 40-70 with documented or measured elevated blood pressure, mild hypertension or moderate hypertension who received DehydraTECH-CBD every day for a 5-week duration. DehydraTECH-CBD doses escalated between 225 mg/day to 450 mg/day over the study duration adjusted relative to body weight. Some volunteers were already using leading standard of care hypertension drugs such as angiotensin-converting enzyme inhibitors with or without diuretics and/or calcium channel blockers, which will help evaluate the safety and efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study allowed Lexaria to gather critical data monitoring the safety and efficacy of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.
Secondary study outcomes include: vascular health including arterial stiffness and autonomic balance; electrocardiogram analysis; brain structure and function through MRI testing; blood biomarkers; sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory.
Large quantities of data have been gathered since the initiation of the study, and most data analyses will begin in September once results are available from ongoing bioanalyses work upon biological samples collected during the study.
Each of these sets of data may lead to additional applications for DehydraTECH-CBD. For example, the MRI data may assist one of the secondary outcome measurements in the study to evaluate possible positive effects upon brain structure and function; and the detailed psychometric testing may reveal new insights into the potential benefits for mental health. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.
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