LEXXW - Lexaria Discovers that DehydraTECH-CBD Treatment in Hypertension Study HYPER-H21-4 Resulted in Reduction in Pro-Inflammatory Biomarkers
(TheNewswire)
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DehydraTECH-CBD offers distinctive mechanistic benefitsrelated to its growing therapeutic utility
Kelowna, BC - TheNewswire - May 23,2023 - Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”) , a globalinnovator in drug delivery platforms is pleasedto announce additional findings from lastyear’s human clinical study HYPER-H21-4 (“the Study”)demonstrating significant reductions in several pro-inflammatorybiomarkers known to be linked to cardiovascular disease (“CVD”)and a host of other conditions.
After five weeks of treatment with the patentedDehydraTECH-processed cannabidiol (“CBD”) capsule formulation,blood-plasma levels of interleukin (“IL”) 8, 10, and 18 werereduced by ~ 19%, ~ 27%, and ~ 43%, respectively. Those personsreceiving five weeks of placebo experienced no significant changes intheir IL levels as shown with the black bars in the graph below. Thedifferences evidenced relative to baseline and/or placebo withpro-inflammatory biomarkers IL 8, 10 and 18 were statisticallysignificant (p<0.05).
Blood Plasma Levels (pg/mL) ofPro-Inflammatory Biomarkers IL-8, IL-10 and IL-18
*Solid bars are at baseline and hollow bars are at endof five weeks of treatment
“ There issome pre-clinical evidence for the anti-inflammatory actions of CBD,but this is likely the most convincing evidence in humans that I haveever seen ,” said Dr. Philip Ainslie,Cardiovascular Advisor to Lexaria and Lead Investigator of StudyHYPER-H21-4. “ The biggerpicture is that inflammation is the key basis of atherosclerosis, andseveral pro-inflammatory agents have been examined as potentialmediators of the biochemical pathways of lesion formation. Other‘common’ diseases or disorders associated with chronicinflammation include fatty liver disease; Type 1 & 2 diabetesmellitus; inflammatory bowel disease; asthma; lung diseases chronickidney disease; rheumatoid arthritis and obesity. Part of the reasonwhy many of these diseases lead to cardiovascular disease is viachronic inflammation .”
There is clear scientific evidence for the involvementof IL-8 in the establishment and preservation of the inflammatorymicroenvironment of the vascular wall in instances of CVD. Incardiovascular risk estimation, several reports have indicated that increased serum levelsof IL-8 are correlated with an increased risk ofCVD or acute cardiovascular events.
IL-10 and IL-18 are alsoconsidered anti-atherosclerotic cytokines with evidence for IL-8 and IL-18 perhaps being even strongerin CVD. In addition , IL-10 levels are knownto increase along with the reduction of kidneyfunction ; and higher serum IL-10levels have been associated with the risk of cardiovascular events during follow-up .Similarly, IL-18 is an independent predictor of cardiovascular eventsin patients with metabolic syndrome . Inlarge population-based studies, circulating IL-18 is prospectively andindependently associated with CVDrisk .
Lexaria previously announced that the primary efficacyand safety objectives of the Study were successfully achieved, withresting blood pressure significantly reduced in hypertensive patients,and sustained 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 researchstudies , mostly in young, healthy andnormotensive volunteers, that have investigated whether a sustaineddecrease in resting blood pressure is possible following multipleweeks of oral CBD dosing; none of which have been successful inachieving this.
I n addition, Lexaria alsopreviously announced data from the Study revealing potentially aunique mechanistic benefit upon cardiovascularregulation via catestatin modulation with DehydraTECH-CBD treatmentthat has not previously been demonstrated with testing of CBD forblood pressure reduction to its knowledge. This finding togetherwith today’s announcement of improvements in pro-inflammatorybiomarker levels related to cardiovascular and related disease statesfurther strengthens the case for DehydraTECH-CBD offeringdistinctive mechanistic benefits related to its growing therapeuticutility . These reductions in inflammation alsoprovide an mechanistic additional pathway by which DehydraTECH-CBD mayact to lower blood pressure.
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 .
DehydraTECH’s Relationship to theHypertension Market
Over 100 million adult Americans have high bloodpressure, but only one infour of those have the conditionunder control. Many patients stop taking their medications because oftroublesome side effects: some diuretics can cause excessiveurination, beta blockers can cause erectile dysfunction,calcium-channel blockers can cause leg swelling, and ACE inhibitorscan lead to persistent cough. 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 blood pressure with fewer discouraging andunwanted side effects.
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 blood pressure with combinations of existingmedications. Of note, the decreases in bloodpressure evidenced in the Study were similar in both thosehypertensive patients on standard of care bloodpressure medications and those who were untreated for theirhypertension upon Study entry. Therefore, Lexaria’s findingsindicate that Lexaria’s DehydraTECH-CBD has the potential to offercomplementary and additive blood pressure reduction benefits on top ofany degree of improvements the standard of care medications provided. This additive improvement of DehydraTECH-CBD as an adjunct therapy,perhaps related to its pronounced effectiveness in modulatingcatestatin and pro-inflammatory cytokine levels, could become asignificant value enhancer should it eventually enter the marketplaceas an approved hypertension treatment.
Study HYPER-H21-4 together with four previous humanclinical studies in hypertension Lexaria conducted from 2018 through2022 are integral to successful filing and review of its upcomingPhase 1b investigational New Drug (“IND”) application to the U.S.Food and Drug Administration (“FDA”) for purposes of its plannedU.S. study HYPER-H23-1. Lexaria’s five foundational human clinicalstudies to-date in this area have been carried out in an aggregatetotal of 134 healthy and hypertensive persons and have evidencedsignificant reductions in resting blood pressure over both acute andmulti-week dosing regimens while producing zero serious adverseevents.
Additional endpoint analyses from HYPER-H21-4 asdescribed in the complete studyprotocol are still underway and anyrelevant material findings will be reported upon as these findingsbecome available.
Study HYPER-H23-1 is entitled ‘ A Phase 1b Randomized, Double-Blind,Placebo-Controlled Study of the Safety, Pharmacokinetics, andPharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage2 Hypertension' . The primary objective of thestudy will be to evaluate safety and tolerability in hypertensivepatients, and secondary objectives will include efficacy evaluation inreducing blood pressure together with detailed pharmacokinetictesting. Lexaria anticipates filing the IND this summer withhoped-for FDA authorization within 60 days thereafter.
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 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 30 patents granted and many patents pendingworldwide. For more information, please visit www.lexariabioscience.com .
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