LEXXW - Lexarias DehydraTECH-CBD Hypertension Study HYPER-H21-4 Dosing Complete with No Serious Adverse Events
(TheNewswire)
Kelowna, British Columbia – TheNewswire - July 27, 2022 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or“Lexaria”), a global innovator in drug delivery platforms ispleased to announce that dosing with Lexaria’sDehydraTECH™-processed cannabidiol (“DehydraTECH-CBD”) has beencompleted in its multi-week human clinical hypertension studyHYPER-H21-4, and that no serious adverse events have been reported asa result of the dosing.
HYPER-H21-4 , is a randomized, double blinded, placebo-controlled,cross-over study that was designed to enrol aminimum of 60 patients. Dosing has now completed, meaning all patientsat different times during the study have now received both the fullDehydraTECH-CBD dose regimen as well as the placebo. A total of 64patients were dosed in this study. Maximum dose levels were roughly5 mg/kg/day which is significantly lower than maximum dose levelspracticed for other regulator-approved pharmaceutical CBDapplications, which Lexaria postulates may be beneficial in avoidingunwanted side effects such as clinically significant elevated liverenzymes sometimes reported in the published scientific literature athigher dose levels.
“We are extremely pleased that dosing has beencompleted on time in this multi-week clinical study without anyserious adverse events having occurred,” said Chris Bunka, CEO ofLexaria Bioscience Corp. “Demonstrating a noteworthy safety andtolerability profile relative to conventional anti-hypertensivemedications is one of Lexaria’s major goals with this program, andavoiding serious adverse events at clinically efficacious doses willbe a primary requirement to achieve eventual regulatory marketingauthorizations.”
HYPER-H21-4 is designed to enhance Lexaria’sprobabilit y of success toward an Investigational New Drug (“IND”) application filing toseek U.S. 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 mentof cardiovascular and other disease statesbeyond hypertension related to increased arterialstiffness and blood biochemistry , pursuant to earlier promising findings in thisarea . HYPER-H21-4 follows Lexaria’s previouslyannounced successes in significantly reducing blood pressure in similarly hypertensive human volunteers in its 2021 studies HYPER-H21-1 and HYPER-H21-2 .
HYPER-H21-4 consisted of male and female 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 received DehydraTECH-CBD every day for a 5-week duration.DehydraTECH-CBD doses escalated between 225 mg/day to 450 mg/day overthe study duration adjusted relative to body weight. Some volunteerswere already using leading standard of care hypertension drugs such asangiotensin-converting enzyme (“ACE”) inhibitors with or withoutdiuretics and/or calcium channel blockers, which will help evaluatethe safety and efficacy of DehydraTECH-CBD with and without otherhypertension treatments. The extended duration of the study allowedLexaria to gather 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 clinicalstudy previously undertaken by Lexaria and many types of analysis willbe performed 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 renal, hepatic inflammation,lipids such as cholesterol and more); sleep quality / daytimesleepiness / sleep disorders; actigraphy, geriatric depression scale,perceived stress, and Beck anxiety inventory. Large quantities of datahave been gathered since the initiation of the study, and most dataanalyses will begin in September once results are available fromongoing bioanalyses work upon biological samples collected during thestudy.
Each of these sets of data may lead to additionalapplications for DehydraTECH-CBD. For example , the MRI data may assist one of thesecondary outcome measurements in the study to evaluate possiblepositive effects upon brain structure and function; and the detailedpsychometric testing may reveal new insights into the potentialbenefits for mental health. The wide range of data collection couldprovide additional insights into the long-term health benefits ofDehydraTECH-CBD that might otherwise remain undetected.
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 with cannabinoids, antiviral drugs,PDE5 inhibitors 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 25 patents granted, 1patent allowed, and roughly 50 patents pending worldwide. For moreinformation, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKINGSTATEMENTS
This press release includes forward-looking statements.Statements as such term is defined under applicable securities laws.These statements may be identified by words such as"anticipate," "if," "believe,""plan," "estimate," "expect,""intend," "may," "could,""should," "will," and other similar expressions.Such forward-looking statements in this press release include, but arenot limited to, statements by the company relating the Company’sability to carry out research initiatives, receive regulatoryapprovals or grants or experience positive effects or results from anyresearch or study. Such forward-looking statements are estimatesreflecting the Company's best judgment based upon current informationand involve a number of risks and uncertainties, and there can be noassurance that the Company will actually achieve the plans,intentions, or expectations disclosed in these forward-lookingstatements. As such, you should not place undue reliance on theseforward-looking statements. Factors which could cause actual resultsto differ materially from those estimated by the Company include, butare not limited to, government regulation and regulatory approvals,managing and maintaining growth, the effect of adverse publicity,litigation, competition, scientific discovery, the patent applicationand approval process, potential adverse effects arising from thetesting or use of products utilizing the DehydraTECH technology, theCompany’s ability to maintain existing collaborations and realizethe benefits thereof, delays or cancellations of planned R&D thatcould occur related to pandemics or for other reasons, and otherfactors which may be identified from time to time in the Company'spublic announcements and periodic filings with the US Securities andExchange Commission on EDGAR. There is no assurance that any ofLexaria’s postulated uses, benefits, or advantages for the patentedand patent-pending technology will in fact be realized in any manneror in any part. No statement herein has been evaluated by the Food andDrug Administration (FDA). Lexaria-associated products are notintended to diagnose, treat, cure or prevent any disease. Anyforward-looking statements contained in this release speak only as ofthe date hereof, and the Company expressly disclaims any obligation toupdate any forward-looking statements contained herein, whether as aresult of any new information, future events, changed circumstances orotherwise, except as otherwise required by law.
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