LXRP - Lexaria Expands R&D Program to Address US$28 Billion Hypertension Market with Addition of Two Human Clinical Studies
(TheNewswire)
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- Hypertension program evaluatingeffectiveness of DehydraTECH-processed CBD now consists of three humanclinical studies and two animal studies
Kelowna, British Columbia – TheNewswire - February 11, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (CSE:LXX) (CNSX:LXX.CN) (the “Company” or“Lexaria”), a global innovator in drug delivery platforms,announces significant progress in its 2021 applied research anddevelopment (R&D) program with additional focus onhypertension.
“Over 1.1 billion people suffer from hypertension,”said Chris Bunka, CEO of Lexaria. “Pending successful completion ofLexaria’s study programs, we intend to pursue opportunities forgrowth through strategic partnerships with leading companies active inthe hypertension drug or CBD pharmaceutical marketplaces.”
DehydraTECH-CBD For Hypertension
The overall 2021 Lexaria hypertension program nowconsists of a total of five studies, three of which were described inthe Company’s announcement on February 1, 2021 and updated here(HYPER-A21-1, HYPER-A21-2, and HYPER-H21-1), and two new additions,which are announced now for the first time (HYPER-H21-2 andHYPER-H21-3).
Study design for the Company’s planned animal studiesHYPER-A21-1 and HYPER-A21-2 has been completed, and delivery of theformulations to be tested to the third-party laboratories in goodcondition has been confirmed. Dosing remains on schedule, and isexpected to begin in late February or early March.
HYPER-H21-1 as previously announced, and the newadditions, HYPER-H21-2 and HYPER-H21-3, are each randomized,double-blinded human clinical studies to take place in Europe. Studydesign for HYPER-H21-1 is complete and university hospital and ethicsboard approvals have been received. Subject dosing for HYPER-H21-1will begin after shipment of the clinical test articles to theclinical site is completed, pending regulatory clearances forimportation as previously announced.
HYPER-H21-2 has been added to the Lexaria hypertensionprogram due to the increasing importance that this work could have onLexaria’s commercial prospects. This study is designed to monitorambulatory blood pressure during a 24-hour period after subjectdosing, with subjects wearing portable devices that will record bloodpressure at 30-minute and 60-minute intervals. Volunteers will visitthe laboratory three times and receive either a placebo or a 150mgdose of DehydraTECH-CBD, three times daily. The results of thisstudy will contribute to the understanding of the effectiveness ofpatented DehydraTECH-processed CBD as a potential novelanti-hypertensive agent through the course of a full day ofmonitoring, which is expected to be complementary to the shorter-termmonitoring in HYPER-H21-1. Study design for HYPER-H21-2 is completeand university hospital and ethics board approvals are pending,following which the Company will be able to provide additional detailson expected timing of commencement of subject recruitment anddosing.
HYPER-H21-3 is also a double-blinded, placebocontrolled, randomized human clinical study that has been added toLexaria’s hypertension program to complement the data set theCompany intends to build. This study is designed to monitoreffectiveness of a 300 mg dose of DehydraTECH-CBD relative to placeboon blood pressure in volunteers under conditions of hypoxic pulmonaryvasoconstriction. Data from this study may demonstrate utility ofDehydraTECH-CBD for blood pressure reduction in circumstances wherepulmonary edema/hypertension results as occurs, for instance, whenpeople travel to high altitude regions of the world. Study designfor HYPER-H21-3 is complete and university hospital and ethics boardapplications are under development and should be submitted shortly.Once approvals are received the Company will be able to providedetails on timing of executing this study.
The five studies in Lexaria’s 2021 hypertensionprogram are expected to generate data required to further support thevalidity of using DehydraTECH-processed CBD as a potentialhypertension treatment across various applications. Lexaria hasreceived 18 granted patents internationally, including issuances inthe European Union and Australia specifically to useDehydraTECH-processed CBD to treat heart disease.
DehydraTECH with Antivirals for COVID-19
As referenced in Lexaria’s announcements on December22, 2020 and February 1, 2021, VIRAL-C21-3 study is designed toevaluate the relative antiviral activity of certain DehydraTECHformulations in an effort to kill the virus in an established cellculture model of SARS-CoV-2 infected cells. This study protocol designis now complete and commencement of the laboratory work is expected inMarch, as previously announced.
Lexaria relies on applied R&D programs to generateconfirmatory results and data evidencing improved drug deliverycharacteristics that enable pursuit of commercial opportunities and/orcorporate relationships. As such, Lexaria considers these appliedR&D studies to be a vital early step in establishing commercialrelationships with potential industry partners to utilize DehydraTECHwithin their existing product lines or in the development of newproduct lines.
Applied R&D studies often also provide test datathat support existing patent applications and, at times, produce datathat could support additional new patent applications. (UnderLexaria’s identification protocols, “A21” designates a 2021animal study, whereas “H21” designates a 2021 human study and“C21” designates a cell culture study.)
All studies referenced within this press release are fully funded fromexisting Company resources
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. DehydraTECH has repeatedly demonstrated since 2016 withcannabinoids and nicotine the ability toincrease bio-absorption by up to 5-10x, reduce time of onset from 1 -2 hours to minutes, and mask unwanted tastes; and is planned to befurther evaluated for orally administered bioactive molecules,including anti-virals, cannabinoids, vitamins, non-steroidalanti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensedDehydraTECH to multiple companies including a world-leading tobaccoproducer 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 18 patents granted and approximately 60 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 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 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 topandemics, and other factors which may be identified from time to timein the Company's public announcements and periodic filings with the USSecurities and Exchange Commission on EDGAR. There is no assurancethat any of Lexaria’s postulated uses, benefits, or advantages forthe patented and patent-pending technology will in fact be realized inany manner or in any part. No statement herein has been evaluated bythe Food and Drug Administration (FDA). Lexaria-associated productsare not intended 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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