Lexaria Bioscience Completes Dosing in Hypertension Study, HYPER-H21-1
Kelowna, British Columbia -- June 7, 2021 -- NewsGenie -- Lexaria Bioscience Corp. (Nasdaq:LEXX) has completed treatment and dosing in its human clinical study (HYPER-H21-1) ahead of schedule. The study focused on testing DehydraTECH-enabled cannabidiol (CBD) for hypertension treatment.
Twenty-four volunteers aged 45 to 65 were dosed, tolerating the treatment well, with no serious adverse events reported. CEO Chris Bunka acknowledged the challenges of conducting the study during the COVID-19 pandemic, commending the research partners' dedication. Blood samples will be shipped to analytical testing labs, with sample and data analyses expected by July or August.
HYPER-H21-1 was a randomized, double-blinded, controlled study in volunteers with pre- or mild hypertension. A single 300 mg dose of an advanced “DehydraTECH 2.0” CBD formulation was evaluated against a control. Primary objectives included blood pressure and heart rate analyses. Secondary objectives included assessments of CBD absorption, inflammatory markers, and nitric oxide biomarkers.
Lexaria also announced the immediate commencement of its second human clinical study of 2021, HYPER-H21-2. This study will involve 16 pre- or mildly hypertensive volunteers receiving three separate 150 mg doses of DehydraTECH 2.0-enabled CBD versus placebo (450mg total). HYPER-H21-2 includes 24-hour ambulatory monitoring of blood pressure and heart rate, along with evaluations of arterial stiffness, physical activity, and sleep quality. Treatment and dosing visits should be completed in July, with reporting expected in late September.
Lexaria's DehydraTECH technology improves how active pharmaceutical ingredients enter the bloodstream, enhancing the effectiveness of fat-soluble molecules and reducing overall dosing. The technology can be applied to foods, beverages, and oral suspensions. DehydraTECH has demonstrated increased bio-absorption, reduced onset time, and masked unwanted tastes.