In human study HYPER-H21-1, the recruiting of 24 volunteers with otherwise untreated pre- or mild-hypertension has begun, and dosing using a single 300mg dose of CBD with or without DehydraTECH formulation enhancement is tentatively expected to be completed by May this year
Lexaria Bioscience Corp (CSE:LXX) (OTCMKTS:LXRP) has updated investors on the progress of assessing its DehydraTECH CBD technology in treating high blood pressure, noting that all five of its planned studies for this year are now underway.
Three human clinical trials and two animal research studies are in progress.
READ: Lexaria Bioscience expands DehydraTECH CBD hypertension program with two new human trials; updates for others
In the human study HYPER-H21-1, the recruiting of 24 volunteers with otherwise untreated pre- or mild-hypertension has begun, and dosing using a single 300mg dose of CBD with or without DehydraTECH formulation enhancement, is tentatively expected to be completed by May this year.
In human trial HYPER-H21-2, formal hospital and ethics board applications for an upcoming European study have been approved and test articles are expected to arrive at the research site as early as next week. Following this, recruitment of 16 volunteers will start soon, said Lexaria.
In the third study, formal hospital and ethics board approvals for a European human clinical study have also been received and test articles are also expected to arrive at the research site as early as next week. Following this, 16 volunteers will be recruited once recruitment in studies HYPER-H21-1 and HYPER-H21-2 is complete, the company said.
In the animal studies, in the HYPER-A21-1 trial, results should be reported in or around the first half of May this year. Dosing is complete and no observed behavioural tolerability issues were noted during or after. This study is evaluating the rate of absorption and speed with which various new enhanced DehydraTECH experimental formulations - "DehydraTECH 2.0" - to deliver CBD to the bloodstream and brain.
In the second HYPER-A21-2 study, dosing is scheduled to begin next week and is expected to be completed in this animal study by March 30. This study is also evaluating the rate of absorption and speed with which additional enhanced DehydraTECH 2.0 formulations deliver CBD to the bloodstream and brain. Results should be reported in or around the first half of June, said Lexaria.
Lexaria is a Canadian company with a patented technology that promises to change the way drugs are delivered into the body. It says these R&D studies are a vital early step towards establishing commercial relationships with potential industry partners to use DehydraTECH within existing product lines or to develop new ones.
It says the US annual hypertension drug market is worth US$28 billion. Also, direct healthcare costs for patients with pulmonary arterial hypertension has been estimated at between US$29,712 and $142,500 per year.
Lexaria holds 18 granted patents internationally, including issuances in the European Union and Australia specifically to use DehydraTECH-processed CBD to treat heart disease.
Contact the author at giles@proactiveinvestors.com