Benzinga | Jul 29, 2021 07:16AM EDT

Lexaria Highlights Results From Human Clinical Study Of HYPER-H21-1

Human Clinical Study HYPER-H21-1 evidences a rapid and sustained drop in blood pressure with DehydraTECH-CBD and excellent tolerability

Kelowna, British Columbia -TheNewswire -July 29, 2021-Lexaria Bioscience Corp.(NASDAQ:LEXX) (NASDAQ:LEXXW)(the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue partial results from human clinical study HYPER-H21-1 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 and all other data analyses including pharmacokinetic ("PK") evaluations and detailed blood chemistry work is in progress and will be released when complete.



"We are very encouraged by these early results in our 2021 hypertension program," said Chris Bunka, CEO of Lexaria. "Lexaria's technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in Stage 2 hypertensive volunteers."



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 that, "these early results are extremely promising in this at-risk hypertensive population and provide a fundamental support for expansion into more prolonged repeat dosing and future longer term clinical trials."



BP was reduced across both male and female volunteers and was most pronounced with DehydraTECH-CBD in the first 10-50 minutes of the study, reinforcing our pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic CBD controls.



Blood pressure reduction from baseline was greatest when measured via systolic pressure. In the subset of volunteers who were Stage 2 hypertensive, peak systolic BP reductions from baseline were observed of as much as approximately 13 mmHg by the 50-minute time point with DehydraTECH-CBD, and systolic BP remained depressed throughout almost the entire 3-hour duration of the study. For reference,other studiesof coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mm Hg or diastolic pressure by 5 mm Hg 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%."



There was also a tendency for a greater reduction in relative diastolic pressure from baseline with DehydraTECH-CBD than the concentration matched, generic CBD control (Fig 1). This was most notable in the initial 10-20 minute period post-dosing evidencing statistical significance at the 20-minute timepoint (p=0.025).





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Fig 1. Changes in diastolic blood pressure betweengeneric CBD control(dose A) andDehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.



As well, there was a tendency for relative Mean Arterial Pressure ("MAP") to be reduced greater from baseline with the DehydraTECH-CBD than the concentration matched, generic CBD control; again, most notably in the initial 20 minutes post-dosing (Fig 2.). By comparison, in Lexaria's 2018 humanclinical study, 120 minutes were required to achieve the same level of MAP reduction, demonstrating superior rapidity of onset of the "DehydraTECH 2.0" CBD formulation used in the present study relatively speaking.





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Fig 2. Changes in mean arterial blood pressure betweengeneric CBD control(dose A) andDehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.



Lexaria was also pleased that its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported. Ingestion of the concentration-matched, generic CBD control, on the other hand, resulted in unwanted side effects in some of the volunteers, namely gastrointestinal distress including diarrhea. These findings corroborate what Lexaria has previously evidenced in other unrelated studies whereby human volunteers have also experienced reduced side effects with DehydraTECH-processed test articles compared to concentration-matched, generic controls.



Lexaria looks forward to completing its ongoing additional sample and data analyses work for this study and reporting upon those outcomes when complete. Lexaria's second human clinical hypertension study of 2021, study HYPER-H21-2, has completed dosing as previously reported and, in that study, three separate doses of DehydraTECH-CBD (150mg per dose) were used, administered evenly over the course of a 24-hour monitoring period. Based on the BP reducing trends witnessed in the present study, Lexaria is optimistic that repeat dosing such as this over a sustained period may further enhance efficacy. The results of these two studies will be carefully evaluated and considered before Lexaria's third planned human clinical hypertension study of 2021 begins, expected this Fall. Lexaria is evaluating study considerations for a fourth, expanded, randomized, controlled human clinical hypertension trial, with a view to building upon the results of current investigations in a larger population for enhanced statistical and clinical significance.



About Human Study HYPER-H21-1

Human Study HYPER-H21-1 was conducted at aEuropean medical research hospital. Twenty-four human volunteers aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a single 300mg dose of generic CBD, or a single 300mg dose of DehydraTECH-CBD and studied over a 3-hour duration. The weight of the average woman in the study was 178 lbs, and the weight of the average man in the study was 223 pounds. Blood pressure and heart rate analyses were taken every 10 minutes and speed and rate of absorption of the CBD and its main metabolites (PK assessments) were also assessed during the study. Secondary analyses that will be reported when complete include evaluation of inflammatory and oxidative markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure provides mechanistic insight into the reduction in blood pressure via vasodilation.



Inflammatory marker assessments may also be applicable to Lexaria's research initiatives in the antiviral therapeutics space whereby effective anti-inflammatory therapies are also useful in treating diseases like COVID-19 or other common pro-inflammatory conditions, where Lexaria has already successfully demonstrated DehydraTECH utility with one such anti-inflammatory drug, colchicine, used for COVID-19 treatment today as previously reported.