Benzinga | Sep 7, 2021 07:13AM EDT

Lexaria Bioscience Announces Initial Results From Human Clinical Study Of DehydraTECHTM; Study Evidences Up To 23% Decrease In Blood Pressure With DehydraTECH-CBD Relative to Placebo

Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue initial results from human clinical study HYPER-H21-2 evaluating DehydraTECHTM-processed cannabidiol ("CBD") for potential application against hypertension. Partial results related to blood pressure ("BP") are being released today, while additional BP subset analyses, sleep quality and all other data analyses are in progress and will be reported upon when complete.

At selected times during the 24-hour study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 7.0% (p < 0.001) in systolic pressure with DehydraTECH-CBD relative to placebo as shown below in Figure 1.

Figures 1, 2, and 3 below: Changes in 24-hr ambulatory systolic pressure (SBP), mean arterial pressure (MAP) and diastolic pressure (DBP) between placebo (blue) and DehydraTECH-CBD (purple). Data are grouped means (n=16) with linear regression denoted by the trend lines. Timing of the three administered doses of DehdyraTECH-CBD (150 mg CBD x 3 dosing intervals) is indicated by the vertical arrows.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 5.3% (p < 0.001) in MAP with DehydraTECH-CBD relative to placebo, as shown below in Figure 2.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 3.5% in diastolic pressure relative to an increase in diastolic pressure (-0.8 vs. +2.7; p<0.001) from baseline with DehydraTECH-CBD relative to placebo, as shown below in Figure 3.

Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health, University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, commented, "These improvements in BP results are particularly remarkable given the fact that many existing drugs used to treat hypertension require several weeks of treatment and/or combination dosing before they produce comparable reductions in blood pressure.

"Over the initial 24 hours, Lexaria's 2021 hypertension program is now delivering blood pressure reduction results competitive with - and in some cases even superior to - established oral pharmaceutical hypertension drugs," said Chris Bunka, CEO of Lexaria. "DehydraTECH-CBD demonstrated a sustained and augmented effect upon blood pressure attenuation throughout the day, indicating effectiveness of the repeat dosing treatment schedule used in this study."

DehydraTECH-CBD triggered its most significant effects upon BP attenuation through the overnight period while subjects slept and in the early morning period. This observation could have tremendous value therapeutically as these periods of the day are most often associated with cardiac stress and infarct events in hypertensive patients when people rise suddenly from and/or become increasingly active relative to the supine/sleeping state.

Analysis of the physical activity levels of the volunteers with mild to moderate hypertension during the 24-hour monitored period showed no significant differences in activity between the placebo and the DehydraTECH-CBD treated volunteers, indicating that the observed differences in BP were not due to disparate physical movement or demands.

Other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mmHg or diastolic pressure by 5 mmHg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."

Lexaria was also pleased that, as in past studies, its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported or incidence differences between groups. Over 100 million adult Americans have high blood pressure, but only one in four of those have the condition under control. Many patients stop taking their medications because of troublesome side effects: some diuretics can cause excessive urination, beta blockers can cause erectile dysfunction, calcium-channel blockers can cause leg swelling, and ACE inhibitors can lead to persistent cough. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects.