Kelowna-based Lexaria Bioscience Corp. today announced that it had completed the treatment and dosing in its human clinical study, HYPER-H21-1, ahead of schedule.
According to Lexaria, a third party conducted the study, bearing all responsibility for study recruitment, procedures, and analytical testing.
CBD for Blood Pressure Health
The study focused on using Lexaria’s DehydraTECH-enabled CBD formulation as an alternative treatment for hypertension.
HYPER-H21-1 involved 24 human volunteers between the ages of 45 and 65 with documented pre-hypertension or mild hypertension.
Lexaria says that all volunteers tolerated the treatment well, experiencing no serious adverse events or side effects.
“Completing this work in the midst of the COVID-19 pandemic was challenging, and we acknowledge and commend the dedication and work ethic of our Europe-based research partners and all parties involved,” says Lexaria CRO Chris Bunka. “Blood samples from the study volunteers will be shipped this week to our U.S. and Canadian analytical testing laboratory partners, and we expect to complete all sample and data analyses and reporting ahead of schedule, by July or August instead of the end of Q3 as previously indicated.”
The HYPER-H21-1 study utilized a randomized, double-blinded controlled model and single 300mg doses of Lexaria’s DehydraTECH 2.0 CBD formulation.
The study evaluated DehydraTECH 2.0 against a concentration-matched control without the formula’s enhancements.
According to Lexaria, the primary objectives of the study included the evaluation of time series blood pressure and heart rate analyses.
Secondary objectives centered around the absorption rate and speed of CBD and its metabolites, evaluation of inflammatory markers related to cardiovascular disease, and gold-standard biomarkers of nitric oxide.
Lexaria says the nitric oxide data provides mechanistic insight into the anticipated reduction in blood pressure through the opening of blood vessels (vasodilation).
According to Lexaria, inflammatory assessments, including anti- and pro-inflammatory biomarkers, may apply to company research initiatives in the antiviral sector.
Possible applications of anti-inflammatory therapies may include the treatment of diseases like COVID-19 and other common pro-inflammatory conditions.
Lexaria says it will begin its second human clinical study of 202, HYPER-H21-2, immediately and include 16 volunteers with pre or mildly hypertensive symptoms.
Each volunteer will receive three separate 150mg doses of the DehydraTECH 2.0 CBD formulation versus a 450mg-total-dose placebo.
The study will include continuous 24-hour blood pressure and heart rate monitoring along with arterial stiffness, physical activity, and sleep quality evaluations.
Sleep quality evaluations will include sleep efficiency, total wake time, and total sleep time.
Lexaria expects to finish all treatment and dosing visits in or around July and complete sample and data analyses by late September.
Lexaria says it may report preliminary outcomes sooner if they become available.