Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ: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.

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.

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.