LEXXW - Lexaria Discovers Potential Novel Mechanism from Hypertension Study HYPER-H21-4
(TheNewswire)
Kelowna, British Columbia – TheNewswire - February 21, 2023 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms is pleased to announce additional findings from its human clinical study HYPER-H21-4(“the Study”) demonstrating a potentially novel mechanism ofaction of its patented DehydraTECH-processed cannabidiol (“CBD”)capsule formulation in reducing blood pressure("BP").
The Food and Drug Administration (“FDA”) has laidout clear guidelines forsponsors who seek to develop newanti-hypertensive drugs, specifically defining the need formedications that offer complementary modes of action. Lexaria believesthat its latest results, detailed below and already peer-reviewed andpublished in the respected journal,“ Biomedicine andPharmacotherapy ” , maysupport DehydraTECH-CBD qualification within these FDAguidelines .
Lexaria previously announced that the primary efficacyand safety objectives of the Study were successfully achieved, withresting BP significantly reduced in hypertensive patients, andsustained over the full 5-weeks of dosing with zero seriousadverse events being reported throughout the Study. Lexaria is aware of only a handful of other published research studies , mostly inyoung, healthy and normotensive volunteers, that have investigatedwhether a sustained decrease in resting BP is possible followingmultiple weeks of oral CBD dosing; none of which have been successfulin achieving this.
Ongoing analyses of the Study data have revealedmodulation of a circulating compound called catestatin in thepatients. Catestatin is a multifunctional peptide known to haveinhibitory effects on the sympathetic nervous system in thepathophysiology of hypertension.
*Friedman test withpost-hoc Wilcoxon test
These analyses (illustrated above) revealed thatadministration of DehydraTECH-CBD resulted in a statisticallysignificant reduction in average baseline serum catestatinconcentrations of 13.50 ng/mL to just 9.65 ng/mL after 5 weeks ofdosing, which is a large drop of 28.5% (p < 0.001). There were no statistically significant reductions incatestatin concentrations in the placebo group. As previouslyreported, mean arterial pressure also dropped significantly by 4.26 ±1.26 mm/Hg following the 5-week period of DehydraTECH-CBD dosingand this reduction (p = 0.039) was not observed with placebo.The extent of change in catestatin serum levels showed a strongcorrelation with the reduction in blood pressure (r = 0.71; p <0.001).
Overall, these latest results from study HYPER-H21-4imply that the antihypertensive effects ofDehydraTECH-CBD may be explained, at least in part, by itsinteraction with the sympatho-chromaffin system via catestatinmodulation. This suggests a potentially unique mechanistic benefitupon cardiovascular regulation with DehydraTECH-CBD treatment that hasnot previously been demonstrated, to our knowledge, with testing ofCBD for blood pressure reduction. CBD is known to have a widearray of distinct effects upon cardiovascular regulation. Theseinclude effects upon blood vessel tone, vascularinflammation, blood pressure, and cardiac contractility. Themechanisms of these observations are complex and involves interactionwith receptors other than cannabinoid receptors, including actionsexerted through various naturally occurring mediator compounds in thebody.
There is a clear medical and market need foralternative anti-hypertensive therapies, especially in the case ofpatients with so-called resistant hypertension who fail to adequatelycontrol their high BP with combinations of existing medications. Ofnote, the decreases in BP evidenced in the Studywere similar in both those hypertensive patients on standard of careBP medications and those who were untreated for their hypertensionupon Study entry. Therefore, the current results indicate thatLexaria’s DehydraTECH-CBD has the potential to offer complementaryand additive BP reduction benefits on top of any degree ofimprovements the standard of care medications provided. Thisadditive improvement of DehydraTECH-CBD as an adjunct therapy, perhapsrelated to its pronounced effectiveness in modulating catestatinlevels, could become a significant value enhancer should it eventuallyenter the marketplace as an approved hypertension treatment.
Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings willbe reported upon as these findings become available.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream through oral delivery. Since2016, DehydraTECH has repeatedly demonstrated the ability to increasebio-absorption with cannabinoids, antiviral drugs, 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 28 patents granted and many patents pendingworldwide. For more information, 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 regulatory approvals or grants or experience positiveeffects or results from any research or study. Such forward-lookingstatements are estimates reflecting the Company's best judgment basedupon current information and involve a number of risks anduncertainties, and there can be no assurance that the Company willactually achieve the plans, intentions, or expectations disclosed inthese forward-looking statements. As such, you should not placeundue reliance on these forward-looking statements. Factors whichcould cause actual results to differ materially from those estimatedby the Company include, but are not limited to, government regulationand regulatory approvals, managing and maintaining growth, the effectof adverse publicity, litigation, competition, scientific discovery,the patent 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. TheCompany provides links to third-party websites only as a courtesy toreaders and disclaims any responsibility for the thoroughness,accuracy or timeliness of information at third-party websites. 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 or links to third-party websites contained herein, whetheras a result of any new information, future events, changedcircumstances or otherwise, except as otherwise required bylaw.
INVESTOR CONTACT:
George Jurcic - Head of InvestorRelations
Copyright (c) 2023 TheNewswire - All rights reserved.