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Lexaria's DehydraTECH-CBD Hypertension Study HYPER-H21-4 Dosing Complete with No Serious Adverse Events
KELOWNA, BC / ACCESSWIRE / July 27, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug
About this update from Lexaria Bioscience Corp.
[{"type":"text","content":"KELOWNA, BC / ACCESSWIRE / July 27, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms is pleased to announce that dosing with Lexaria's DehydraTECH™-processed cannabidiol (\"DehydraTECH-CBD\") has been completed in its multi-week human clinical hypertension study HYPER-H21-4, and that no serious adverse events have been reported as a result of the dosing.HYPER-H21-4, is a randomized, double blinded, placebo-controlled, cross-over study that was designed to enrol a minimum of 60 patients. Dosing has now completed, meaning all patients at different times during the study have now received both the full DehydraTECH-CBD dose regimen as well as the placebo. A total of 64 patients were dosed in this study. Maximum dose levels were roughly 5 mg/kg/day which is significantly lower than maximum dose levels practiced for other regulator-approved pharmaceutical CBD applications, which Lexaria postulates may be beneficial in avoiding unwanted side effects such as clinically significant elevated liver enzymes sometimes reported in the published scientific literature at higher dose levels.\"We are extremely pleased that dosing has been completed on time in this multi-week clinical study without any serious adverse events having occurred,\" said Chris Bunka, CEO of Lexaria Bioscience Corp. \"Demonstrating a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications is one of Lexaria's major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations.\"HYPER-H21-4 is designed to enhance Lexaria's probability of success toward an Investigational New Drug (\"IND\") application filing to seek U.S. Food and Drug Administration (\"FDA\") approval to commence registered clinical testing at the Phase I level or higher, to be determined in consultation with the FDA. This human study is also expected to enhance Lexaria's understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension related to increased arterial stiffness and blood biochemistry, pursuant to earlier promising findings in this area. HYPER-H21-4 follows Lexaria's previously announced successes in...