LEXXW - cGMP Manufacturing Complete for Lexaria's Upcoming U.S. Phase 1b Hypertension Clinical Trial
(TheNewswire)
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DehydraTECH-CBD is currently uniquein its evidenced superior power to reduce blood pressure over otheroral CBD formulations.
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DehydraTECH-CBD has demonstratedexceptional safety and tolerability and a sustained decrease in bloodpressure.
Kelowna, British Columbia – TheNewswire - May 11, 2023 –Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms announces that batch manufacturing ofthe DehydraTECH™-processed cannabidiol (“CBD”) and placebomaterials for its upcoming U.S. Phase 1b hypertension clinical trialHYPER-H23-1 has been completed.
Lexaria retained the services of a U.S. contractmanufacturing organization to produce these materials compliant withcurrent Good Manufacturing Practice (“cGMP”) regulations asmandated by the Food and Drug Administration (“FDA”). Fillinginto capsules is expected to be completed this month,follow ed by analyticalrelease and stability testing in order to gatheressential quality control data necessary for Lexaria’s upcomingInvestigational New Drug (“IND”) filing to the FDA, as previouslyagreed upon in last year’s successful pre-IND meeting as announcedon August 10, 2022 .
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, resulting in the Phase 1btrial targeting commencement of patient dosing as early as October2023.
Lexaria’s five previous human clinical studiesconducted from 2018 through 2022, which were not conducted underFDA-registration but are integral to successful filing and review ofits upcoming IND submission, were carried out in an aggregate total of134 healthy and hypertensive persons. These foundational studiesevidenced significant reductions in resting blood pressure over bothacute and multi-week dosing regimens, and also produced zero seriousadverse events; suggesting that DehydraTECH-CBD has the potential tohave pronounced clinical benefits relative to availableanti-hypertensive therapeutics.
Lexaria is aware of only a handful of otherpublished research studies , mostly in young,healthy and normotensive volunteers, that have investigated whether asustained decrease in resting blood pressure is possible followingmultiple weeks of oral CBD dosing; none of which have been successfulin achieving this. DehydraTECH-CBD is currently unique in itsevidenced superior power to reduce blood pressure over other oral CBDformulations.
Findings from Lexaria’s latest study HYPER-H21-4 demonstrated a potentially novelmechanism of action of DehydraTECH-CBD inreducing blood pressure which may be explained,at least in part, by its interaction with the humansympatho-chromaffin system via catestatin modulation as detailed inthe peer-reviewed and published respected journal, " Biomedicine andPharmacotherapy ". This is significant because the FDA haspreviously laid out clear guidelines forsponsors who seek to develop newanti-hypertensive drugs, specifically defining the need formedications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reductionbenefits on top of any degree ofimprovements that standard of care medications achieved for patientsprior to DehydraTECH-CBD dosing.
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 .
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 the testing or use of products utilizing theDehydraTECH technology, 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.
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