LEXXW - Lexarias Pulmonary Hypertension Clinical Study HYPER-H21-3 Delivers Positive Results
(TheNewswire)
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Data from this human study, together withthe findings from Lexaria’s other previously announced successfulstudies, intended to support the Company’s plans to seek approvalsby the U.S. Food and Drug Administration
Kelowna, British Columbia – TheNewswire - April 14, 2021 – Lexaria BioscienceCorp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or “Lexaria”), a global innovator indrug delivery platforms announces that all data analyses from itssimulated pulmonary hypertension clinical study HYPER-H21-3 have beensuccessfully completed with positive safety and efficacyfindings.
The study findings indicated a tendency (p=0.1) during15 minutes of simulated low levels of oxygen (hypoxia) for reducedpulmonary artery systolic pressure (“PASP”) with DehydraTECH-CBDtreatment versus placebo. Most notably, PASP was significantlyattenuated by about 5 mmHg or 41% overall (p=0.045) in maleparticipants specifically suggesting differences by sex inresponsiveness to CBD treatment under hypoxic stress conditions.
These findings are complementary to Lexaria's growingbody of evidence demonstrating the ability of DehydraTECH-CBD toreduce blood pressure, which it has shown across a wide variety ofclinical presentations, ranging from individuals with differingdegrees of “essential hypertension”, the most common form ofhypertension, to individuals with stress-induced simulated pulmonaryhypertension as reported here. These new findings from HYPER-H21-3will help direct prospective future researchinto the efficacy of DehydraTECH-CBD use for the management of elevations in pulmonary arterialpressure under hypoxic conditions (e.g., exposure to altitude),related hypoxemic pathologies (e.g., severe lung disease), andpulmonary hypertension.
Lexaria intends to use the data from study HYPER-H21-3,together with the findings from its other previously announcedsuccessful studies that evidenced DehydraTECH-CBD’s ability to lowerhuman blood pressure, to support Lexaria’s plans to seek approvalsby the U.S. Food and Drug Administration (“FDA”) to commenceformal, registered clinical testing in the treatment of hypertensionunder the Investigational New Drug (“IND”) process.
As in past studies, all study participants toleratedDehydraTECH-CBD well and no serious adverse side effects wererecorded. Lexaria will continue to provideupdates on its work towards IND filing as they become available.
About Study HYPER-H21-3
Study HYPER-H21-3 used a placebo-controlled anddouble-blinded design, with administration of a single 300mg dose of aspecific DehydraTECH-2.0 CBD formulation compared to placebo in atarget group of sixteen enrolled volunteers (8 females and 8 males;aged 18-35 years). The study participants were subjected to a30-minute period of rest following dosing, during which time theybreathed normal room air (i.e., 21% oxygen), followed by a 40-minuteperiod of simulated hypoxia (i.e., 12% oxygen) that was induced inorder to safely simulate robust hypoxic pulmonary vasoconstriction("HPV") and, as a result, an acute state of pulmonaryhypertension. The hypoxia state was intended to mimic conditionsexperienced by those traveling or walking at high altitude or by thoseengaging in other activities of diminished oxygen availabilityconducive to development of HPV. Adverse elevations in HPV alsocommonly occur in related hypoxemic pathologies(e.g., severe lung disease) and pulmonary hypertension. Measurements of PASP were performed via echocardiography atintervals of 15 and 30 minutes during the 40-minute hypoxic periodcomparing the effects of DehydraTECH-CBD to placebo.
Hypertension Markets
The hypertension market is valued at $28 billion peryear and is expected to continuegrowing as one of the world’s top health problems and as a subset ofthe larger heart disease market. Geographically, some of the highestrates of growth are expected in more recently industrialized nationssuch as China and India. Over 1.1 billionpeople worldwide suffer fromhypertension.
Fewer than 1 person in 4 withhypertension have successfullycontrolled their blood pressure (“BP”) through medications,meaning the potential market for hypertension drugs is much largerthan $28 billion per year if an affordable drug was available with fewor no side effects. Lexaria believes that itsDehydraTECH-CBD may introduce a more tolerable anti-hypertensivetreatment option that may be used alone or in combination with othermedications, to reduce BP with fewer discouraging and unwanted sideeffects. Lexaria would seek to satisfy thiscurrently unmet demand and in doing so could expand the overallhypertension 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 sellingdrugs in the world. Lipitor, used totreat high cholesterol and reduce the risk of heart disease, hasgenerated $94.7 billion in revenue from 1992 until 2017. Plavix, usedto prevent heart attack and stroke, has sold $46.5 billion from 1992until 2017. There are several hypertensiondrugs that each generate $1 billionper year or 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 bio-absorption when administeredintraorally and topically.
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 for orally administered anti-viral drugs,non-steroidal anti-inflammatory drugs (NSAIDs), PDE5 inhibitors andmore. DehydraTECH has also evidenced an ability to deliver some drugsmore effectively across the blood brain barrier. Lexaria operates alicensed in-house research laboratory and holds a robust intellectualproperty portfolio with 24 patents granted and over 50 patents pendingworldwide. For more information, 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 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 currentinformation and involve a number of risks and uncertainties, and therecan be no assurance 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 actualresults to differ materially from those estimated by the Companyinclude, but are not limited to, government regulation and regulatoryapprovals, managing and maintaining growth, the effect of adversepublicity, litigation, competition, scientific discovery, the patentapplication and approval process, potential adverse effects arisingfrom 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 - Headof Investor Relations
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