LEXXW - Lexaria Commences Multi-Week Human Clinical Hypertension Study
(TheNewswire)
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HYPER-H21-4 will evaluateDehydraTECH TM -CBDfor reducing blood pressure together with other potential clinical benefits
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This s tudy is designed to enhance Lexaria’s probabilities of success with its expected subsequent Investigational New Drug applicationfiling
Kelowna, British Columbia – TheNewswire - April 19, 2022 –Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms, is pleased to announce that it hasbegun its multi-week human clinical hypertension study .
The study, HYPER-H21-4 , is arandomized, double blinded, placebo-controlled, cross-over study in 60people and the most comprehensive study everundertaken by Lexaria. D osing in more than half the volunteershas already commenced ahead of schedule, with all treatment visitsexpected to conclude in early July, 2022. Baseline brain magneticresonance imaging (“MRI”) scanning has also already begun. Ofsignificant note, there have been no serious adverse events reportedby these volunteers, demonstrating that DehydraTECH-CBD has been welltolerated in those that have received it thus far.
HYPER-H21-4 is designed to enhance Lexaria’sprobabilit y of successwith its expected subsequent Investigational New Drug (“IND”) application filing toseek Food and Drug Administration (“FDA”) approval to commence registered clinical testing at the PhaseI level or higher , to be determined inconsultation with the FDA . This humanstudy is also expected to enhance Lexaria’s understanding of DehydraTECH-CBD for the treat ment of cardiovascular and otherdisease states beyond hypertension related to increased arterialstiffness , pursuant to earlier promisingfindings in this area . HYPER-H21-4 followsLexaria’s previously announced successes in significantly reducingblood pressure i n similarly hypertensive human volunteersin its 2021 studies HYPER-H21-1 and HYPER-H21-2 .
This study is entirely funded through the Company’sexisting cash resources and is not subject to any financingrequirement. Independent Review Board approval was received inDecember 2021. The clinical test articles for this study have beenmanufactured, quality control tested and shipped to the Europeanresearch hospital conducting the study.
HYPER-H21-4 consists of a minimum of 60 volunteersbetween the ages of 40-70 with documented or measured elevated bloodpressure (120/80 to 139/80 mmHg), mild (stage 1) hypertension (140/90to 159/99 mmHg) or moderate (stage 2) hypertension (160/100 to 179/109mmHg) who will use DehydraTECH-CBD every day for a 5-week duration.DehydraTECH-CBD doses will escalate between a range of 225 mg/day to450 mg/day over the study duration. Some volunteers will already beusing leading standard of care hypertension drugs such asangiotensin-converting enzyme (“ACE”) inhibitors with or withoutdiuretics and/or calcium channel blockers, which will help evaluatethe efficacy of DehydraTECH-CBD with and without other hypertensiontreatments. The extended duration of the study will allow Lexaria togather critical data monitoring the safety and efficacy ofDehydraTECH-CBD over time and will evaluate the potential for longerterm health benefits.
HYPER-H21-4 is more comprehensive than any workpreviously undertaken by Lexaria and many types of analysis will beperformed including 24-hour ambulatory blood pressure , which is the primary study outcome.
Secondary study outcomes include: vascular healthincluding arterial stiffness and autonomic balance; electrocardiogram(“ECG”) analysis; brain structure and function through MRItesting; blood biomarkers (including lipids such as cholesterol andmore); renal and hepatic analysis, sleep quality / daytime sleepiness/ sleep disorders; actigraphy, geriatric depression scale, perceivedstress, and Beck anxiety inventory. Each of these sets of data maylead to additional applications for DehydraTECH-CBD. Forexample , the MRI data mayassist one of the secondary outcome measurements in the study toevaluate possible positive effects upon brain structure and function;and the detailed psychometric testing may reveal new insights into thepotential benefits for mental health. The wide range of datacollection could provide additional insights into the long-term healthbenefits of DehydraTECH-CBD that might otherwise remainundetected.
Lexaria will provide further updates on the progress ofstudy HYPER-H21-4 and its IND application enabling program as theybecome available. Details on the outcomes after the expected July conclusion of all treatment visits in study HYPER-H21-4 will follow in due course after performing the necessary data analyses .
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 and as a subset of the larger heart diseasemarket. Geographically, some of the highest rates of growth areexpected in more recently industrialized nations such as China andIndia. Over 1.1 billion people worldwide suffer from hypertension.
Fewer than 1 person in 4 withhypertension have successfully controlledtheir blood pressure through medications, meaning the potential marketfor hypertension drugs is much larger than $28 billion per year if anaffordable drug was available with few or no side effects. Lexaria believes that its DehydraTECH-CBD mayintroduce a more tolerable anti-hypertensive treatment option that maybe used alone or in combination with other medications, to reduce BPwith fewer discouraging and unwanted side effects. Lexaria would seek to satisfy this currently unmet demand andin doing so could expand the overall hypertension market.
“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, 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 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 toimprove the way active molecules enter the bloodstream upon oralingestion. DehydraTECH has also demonstrated enhanced delivery ofcertain active molecules including CBD into brain tissue, whichLexaria believes to be of particular importance for the effectivenessof its DehydraTECH-CBD specifically against hypertension because ofthe significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for otherapplications demonstrating superior bioabsorption when administeredintraorally and topically.
Lexaria BioscienceCorp.’s patented drug delivery technology, DehydraTECH™, improvesthe way active pharmaceutical ingredients (APIs) enter the bloodstreamby promoting more effective oral delivery. Since 2016, DehydraTECH hasrepeatedly demonstrated the ability to increase bio-absorption withcannabinoids and nicotine by up to 5-10x, reduce time of onset from 1- 2 hours to minutes, and mask unwanted tastes; and is also beingevaluated for orally administered anti-viral drugs, non-steroidalanti-inflammatory drugs (NSAIDs), and more. DehydraTECH has alsoevidenced an ability to deliver some drugs more effectively across theblood brain barrier. Lexaria operates a licensed in-house researchlaboratory and holds a robust intellectual property portfolio with 24patents granted and over 50 patents pending worldwide. For moreinformation, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press releaseincludes forward-looking statements. Statements as such term isdefined under applicable securities laws. These statements may beidentified by words such as "anticipate," "if,""believe," "plan," "estimate,""expect," "intend," "may,""could," "should," "will," and othersimilar expressions. Such forward-looking statements in this pressrelease include, but are not limited to, statements by the companyrelating the Company’s ability to carry out research initiatives,receive regulatory approvals or grants or experience positive effectsor results from any research or study. Such forward-looking statementsare estimates reflecting the Company's best judgment based uponcurrent information and involve a number of risks and uncertainties,and there can be no assurance that the Company will actually achievethe plans, intentions, or expectations disclosed in theseforward-looking statements. As such, you should not place unduereliance on these forward-looking statements. Factors which couldcause actual results to differ materially from those estimated by theCompany include, but are not limited to, government regulation andregulatory approvals, managing and maintaining growth, the effect ofadverse publicity, litigation, competition, scientific discovery, thepatent application and approval process, potential adverse effectsarising from the testing or use of products utilizing the DehydraTECHtechnology, the Company’s ability to maintain existingcollaborations and realize the benefits thereof, delays orcancellations of planned R&D that could occur related to pandemicsor for other reasons, and other factors which may be identified fromtime to time in the Company's public announcements and periodicfilings with the US Securities and Exchange Commission on EDGAR. Thereis no assurance that any of Lexaria’s postulated uses, benefits, oradvantages for the patented and patent-pending technology will in factbe realized in any manner or in any part. No statement herein has beenevaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat,cure or prevent any disease. Any forward-looking statements containedin this release speak only as of the date hereof, and the Companyexpressly disclaims any obligation to update any forward-lookingstatements contained herein, whether as a result of any newinformation, future events, changed circumstances or otherwise, exceptas otherwise required by law.
George Jurcic - Head of InvestorRelations
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