LEXXW - Lexaria's DehydraTECH-CBD Lowers Blood Pressure
(TheNewswire)
Human Clinical Study HYPER-H21-1evidences a rapid and sustained drop in blood pressure withDehydraTECH-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 deliveryplatforms is extremely pleased to issue partial results from humanclinical study HYPER-H21-1 evaluating DehydraTECH TM -processedcannabidiol (“CBD”) for potential application againsthypertension. Partial results related to blood pressure (“BP”) arebeing released today, while additional BP subset analyses and allother data analyses including pharmacokinetic (“PK”) evaluationsand detailed blood chemistry work is in progress and will be releasedwhen complete.
“We are very encouraged by these early results in our2021 hypertension program,” said Chris Bunka, CEO of Lexaria.“Lexaria’s technology enabled a rapid and sustained drop in bloodpressure, especially systolic pressure and particularly in Stage 2hypertensive volunteers.”
Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences andCo-Director, Centre for Heart, Lung & Vascular Health Universityof British Columbia Okanagan, and Canada Research Chair inCerebrovascular Physiology, commented that,“ these early results are extremely promisingin this at-risk hypertensive population and provide a fundamentalsupport for expansion into more prolonged repeat dosing and futurelonger term clinical trials.”
BP was reduced across both male and female volunteersand was most pronounced with DehydraTECH-CBD in the first 10-50minutes of the study, reinforcing our pre-existing findingsdemonstrating that DehydraTECH delivers superior performance overgeneric CBD controls.
Blood pressure reduction from baseline was greatestwhen measured via systolic pressure. In the subset of volunteers whowere Stage 2 hypertensive, peak systolic BP reductions from baselinewere observed of as much as approximately 13 mmHg by the 50-minutetime point with DehydraTECH-CBD, and systolic BP remained depressedthroughout almost the entire 3-hour duration of the study. For reference, other studies of coronary heart disease (“CHD”) have concluded that“ lowering systolicpressure by 10 mm Hg ordiastolic pressure by 5 mm Hg using any of the main classes of drugsreduced CHD events (fatal and nonfatal) by about a quarter and strokeby about a third, regardless of the presence or absence of vasculardisease and of pretreatment BP. Heart failure is also reduced by about25% .”
There was also a tendency for a greater reduction inrelative diastolic pressure from baseline with DehydraTECH-CBD thanthe concentration matched, generic CBD control (Fig 1). This wasmost notable in the initial 10-20 minute period post-dosing evidencingstatistical significance at the 20-minute timepoint (p=0.025).
Fig 1. Changes in diastolic bloodpressure between generic CBDcontrol (dose A) and DehydraTECH-CBD ( dose B). Data are grouped means (n=24)with linear regression .
As well, there was a tendency for relative MeanArterial Pressure (“MAP”) to be reduced greater from baseline withthe DehydraTECH-CBD than the concentration matched, generic CBDcontrol; again, most notably in the initial 20 minutes post-dosing(Fig 2.). By comparison, in Lexaria’s 2018 human clinical study , 120 minutes wererequired to achieve the same level of MAP reduction, demonstratingsuperior rapidity of onset of the “DehydraTECH 2.0” CBDformulation used in the present study relatively speaking.
Fig 2. Changes in mean arterialblood pressure between generic CBD control (doseA) and DehydraTECH-CBD( dose B). Data are groupedmeans (n=24) with linear regression.
Lexaria was also pleased that its DehydraTECH-CBD waswell tolerated by all subjects, with no serious adverse events or sideeffects observed or reported. Ingestion of theconcentration-matched, generic CBD control, on the other hand,resulted in unwanted side effects in some of the volunteers, namelygastrointestinal distress including diarrhea. These findingscorroborate what Lexaria has previously evidenced in other unrelatedstudies whereby human volunteers have also experienced reduced sideeffects with DehydraTECH-processed test articles compared toconcentration-matched, generic controls.
Lexaria looks forward to completing its ongoingadditional sample and data analyses work for this study and reportingupon those outcomes when complete. Lexaria’ssecond human clinical hypertension study of 2021, study HYPER-H21-2,has completed dosing as previously reported and, in that study, threeseparate 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 sustainedperiod may further enhance efficacy. The results of these twostudies will be carefully evaluated and considered before Lexaria’sthird planned human clinical hypertension study of 2021 begins,expected this Fall. Lexaria is evaluating study considerations for afourth, expanded, randomized, controlled human clinical hypertensiontrial, with a view to building upon the results of currentinvestigations in a larger population for enhanced statistical andclinical significance.
About Human Study HYPER-H21-1
Human Study HYPER-H21-1 was conducted at a European medical research hospital. Twenty-four humanvolunteers aged 45-65 with otherwise untreated pre- ormild-hypertension were given either a single 300mg dose of genericCBD, or a single 300mg dose of DehydraTECH-CBD and studied over a3-hour duration. The weight of the average woman in the study was 178lbs, and the weight of the average man in the study was 223 pounds.Blood pressure and heart rate analyses were taken every 10 minutes andspeed and rate of absorption of the CBD and its main metabolites (PKassessments) were also assessed during the study. Secondary analysesthat will be reported when complete include evaluation of inflammatoryand oxidative markers associated with cardiovascular disease andgold-standard biomarkers of nitric oxide. This latter measure providesmechanistic insight into the reduction in blood pressure viavasodilation.
Inflammatory marker assessments may also be applicableto Lexaria’s research initiatives in the antiviral therapeuticsspace whereby effective anti-inflammatory therapies are also useful intreating diseases like COVID-19 or other common pro-inflammatoryconditions, where Lexaria has already successfully demonstratedDehydraTECH utility with one such anti-inflammatory drug, colchicine,used for COVID-19 treatment today as previously reported.
CBD in the RegulatoryEnvironment.
CBD under the brand name Epidiolex was approved by theFDA in June 2018 for treating certain types of pediatric seizuredisorders. Recommended dosing of Epidiolex CBD is 2.5mg per kilogramof bodyweight to begin treatment, taken twice per day, increasing to5.0mg per kilogram of bodyweight, taken twice per day. An average 9year-old child weighs about 28 kg , so the FDA recommended dose of Epidiolex would initially be140mg, increasing to 280mg daily for long term use. The average adultman in the US weighs 199.6 lbs (90.7kg), so if he was using CBD atthat same rate, he would require 900mg per day for a sustainable dose.The maximum FDA-approved dose of Epidiolex is 10.0mg per kilogram ofbodyweight, taken twice daily.
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.
“Among persons 50 years of age or older, isolatedsystolic hypertension is the most common form of hypertension, andsystolic blood pressure becomes more important than diastolic bloodpressure as an independent risk predictor for coronary events, stroke,heart failure, and end-stage renal disease (ESRD). The Global Burdenof Disease Study identified elevated blood pressure as the leadingrisk factor, among 67 studied, for death and disability-adjusted life-years lost during2010. “
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 is used to prevent heart attackand stroke, 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 proprietary drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting healthier oralingestion methods and increasing the effectiveness of fat-solubleactive molecules, thereby lowering overall dosing. The Company’stechnology can be applied to many different ingestible productformats, including foods, beverages, oral suspensions, tablets, andcapsules. Since 2016, DehydraTECH has repeatedly demonstrated theability to increase bio-absorption withcannabinoids and nicotine by up to 5-10x, reducetime of onset from 1 - 2 hours to minutes, and mask unwanted tastes;and is planned to be further evaluated for orally administeredbioactive molecules, including anti-viral drugs, vitamins,non-steroidal anti-inflammatory drugs (NSAIDs) and more. Lexaria haslicensed DehydraTECH to multiple companies including a world-leadingtobacco producer for the development of smokeless, oral-based nicotineproducts and for use in industries that produce cannabinoid beverages,edibles, and oral products. Lexaria operates a licensed in-houseresearch laboratory and holds a robust intellectual property portfoliowith 21 patents granted and over 50 patents pending worldwide. Formore information, please visit www.lexariabioscience.com .
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