LEXXW - Lexaria's DehydraTECH(TM)-CBD Reduces Arterial Stiffness Results Confirmed in Human Clinical Study HYPER-H21-2
(TheNewswire)
Results suggest broader applicationsfor DehydraTECH-CBD beyond hypertension
Kelowna, British Columbia - TheNewswire - December 8, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms is pleased to issue follow-up results from human clinicalstudy HYPER-H21-2 confirming that DehydraTECH TM -processedcannabidiol (“CBD”) reduces arterial stiffness, potentiallybroadening its application to treatment of cardiovascular and otherdisease states beyond hypertension where it has already showntremendous promise.
“Reducing arterial stiffness in Lexaria’s recenthypertension study after only a single day of dosing with ourDehydraTECH-CBD is a major discovery,” said John Docherty, Presidentof Lexaria. “We know that increased arterial stiffness iscorrelated with many serious and life-threatening diseases affectingpeople worldwide, and we are optimistic that our latest findings couldhave future widespread implications for promotion of improved humanhealth and wellness.”
Arterial stiffness is a strongpredictor of many aspects of human disease . The impacts of increased arterial stiffnessare not limited only to coronary heart disease such as hypertension,but also include other disease states such as diabetes mellitus, renaldisease and more. It can also be a prognostic marker forcardiovascular events and all-cause mortality, even in asymptomaticindividuals without overt cardiovascular disease.
The efficacy of blood pressure treatment anddifferences in efficacy between different types of antihypertensiveagents is strongly correlated with measuring arterial stiffness,whereby the significant blood pressure reduction effects as previouslyreported with DehydraTECH-CBD from study HYPER-H21-2 appear to havebeen at least partially due to these improvements in arterialstiffness.
The arterial stiffness findings from study HYPER-H21-2are summarized in the table below. Arterial stiffness was measuredthrough pulse wave velocity (“PWV”) evaluation, together withassessments of augmentation index and pressure. All comparisonsbetween DehydraTECH-CBD and placebo were statistically significant (p< 0.01).
| DehydraTECH-CBD |
| Placebo |
| Pulse Wave Velocity (PWV) |
| 8.1 ± 0.3 m/s |
| 8.3 ± 0.3 m/s |
| Augmentation Index (Alx) |
| 28.4 ± 1.4% |
| 32.3 ± 1.3% |
| Augmentation Index corrected to heart rate of 75 BPM(Alx.75) |
| 27.8 ± 1.3% |
| 30.4 ± 1.3% |
| Augmentation Pressure (AugP) |
| 12.0 ± 1.0 mmHg |
| 14.6 ± 1.0 mmHg |
In the table above, smaller numbers are the objective. PWV values normally increase by 0.9 m/s every 10years between the age of 45 and 60 asarterial stiffness increases with aging. It has been estimated thata 1.0 m/s increase in PWV accounts for a 15% increase in cardiovascular and all-casemortality .
To have decreased arterial stiffness to the degreedemonstrated in our present study after only a single day of dosingwith DehydraTECH-CBD is quite remarkable and will be more thoroughlyinvestigated in Lexaria’s upcoming 6-week hypertension studyHYPER-H21-4, where multiple doses over this period are expected todemonstrate additional benefits against hypertension and arterialstiffness.
As first reported on September 7, 2021, at selectedtimes during study HYPER-H21-2, some volunteers with mild to moderatehypertension had reductions of as much as a 20 mmHg (i.e., 23%) dropin blood pressure relative to placebo. When averaged over the 24-hourduration of the study, reductions in diastolic, systolic and meanarterial pressure were all significantly evidenced withDehydraTECH-CBD when compared to the placebo condition. All secondary objectives of human clinical study HYPER-H21-2have now been successfully completed
About DehydraTECH-CBD
DehydraTECH-CBD is a unique CBD formulation Lexaria hasdeveloped and is optimizing based on its patented and proprietaryDehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter thebloodstream upon oral ingestion. DehydraTECH has also demonstratedenhanced delivery of certain active molecules including CBD into braintissue, which Lexaria believes to be of particular importance for theeffectiveness of its DehydraTECH-CBD specifically against hypertensionbecause of the significant influence of central mediation uponblood pressure.
About Human Study HYPER-H21-2
Human Study HYPER-H21-2 was conducted at a European medical research hospital. Sixteen humanvolunteers (8 male; 8 female) aged 45-65 with otherwise untreated pre-or mild-hypertension were given either a placebo, or three separatedoses of 150 mg each of DehydraTECH-CBD over a 14-hour period andstudied over a 24-hour duration. The average weight and height were 91± 13 kg and 173 ± 9 cm. Ambulatory blood pressure was recorded for24 hours.
Hypertension Markets
The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world’stop health problems. Geographically, some of the highest rates ofgrowth are expected in more recently industrialized nations such asChina and India. Over 1.1 billion people worldwide suffer from hypertension – elevated bloodpressure. Hypertension is a major risk factor for cardiovascular andcerebrovascular disease, and accounts for approximately 45% ofcardiovascular disease mortality and morbidityworldwide .
Drugs focused on blood pressure and related conditionsare some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol andreduce the risk of heart disease, has generated $94.7 billion inrevenue from 1992 until 2017. Plavix, used to prevent heart attack andstroke, has sold $46.5 billion from 1992 until 2017. There are several hypertensiondrugs that each generate $1 billion per yearor more in revenue.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting more effectiveoral delivery. Since 2016, DehydraTECH has repeatedly demonstrated theability to increase bio-absorption withcannabinoids and nicotine by 5-10x and, in someinstances with cannabinoids by as much as 27x compared to standardindustry formulations, reduce time of onset from 1 - 2 hours tominutes, and mask unwanted tastes; and is also being evaluated fororally administered anti-viral drugs, non-steroidal anti-inflammatorydrugs (NSAIDs), and more. DehydraTECH has also evidenced an ability todeliver some drugs more effectively across the blood brain barrier.Lexaria operates a licensed in-house research laboratory and holds arobust intellectual property portfolio with 23 patents granted andover 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com .
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