Lexaria Bioscience Corp. LEXX successfully completed dosing for its human clinical hypertension study in July, following weeks of oral cannabidiol (CBD) therapy to treat active hypertensive patients.
The HYPER-H21-4 study used the biotech company’s patented DehydraTECH cannabidiol (CBD) capsule formulation to deliver the drug to patients and they recently released preliminary results. HYPER-H21-4 using DehydraTECH-CBD evidenced:
- Exceptional safety and tolerability
- Statistically significant lowering of 24-hour ambulatory blood pressure (“BP”)
- BP lowered for the entire 5-week study duration
- BP lowered both for patients currently taking other antihypertensive drugs as well as patients not taking any other antihypertensive drugs
HYPER-H21-4 was a randomized, double-blinded, placebo-controlled study that consisted of male and female volunteers between the ages of 40 and 70. The study involved dosing 66 volunteers and measuring for elevated blood pressure, mild (stage 1) hypertension or moderate (stage 2) hypertension.
Lexaria reports that the study achieved all primary safety and efficacy objectives successfully with sustained and significant blood pressure reduction in volunteers over the study’s five-week period with no serious adverse effects reported.
Few other published research studies have investigated the possibility of sustained decrease in resting blood pressure through several weeks of oral CBD dosing, according to Lexaria. And the company says that its product is unique, as none of the other oral CBD formulations have been able to establish the sustained drop in blood pressure that DehydraTECH-CBD has demonstrated via the HYPER-H21-4 study.
Hypertension – A Silent Killer?
Hypertension, or elevated blood pressure, is considered one of the world’s top health problems with over 1.1 billion people worldwide suffering from it. It reportedly increases the risk for cardiovascular and cerebrovascular disease manifold and accounts for more than 45% of all cardiovascular mortality and morbidity worldwide.
The hypertension market is valued at $28 billion per year and hypertension is expected to remain one of the world’s top diseases. Drugs focused on blood pressure and related conditions are some of the highest selling in the world, with several hypertension drugs each generating $1 billion or more in revenue per year.
DehydraTECH-CBD: Why It Could Be A Superior Treatment For Hypertension
DehydraTECH is Lexaria’s proprietary drug delivery technology, which improves the way active pharmaceutical ingredients (APIs) in orally ingested drugs enter the bloodstream. It is believed to promote healthier delivery methods and increase the effectiveness of fat-soluble active molecules and orally ingested drugs, including tablets, capsules and oral suspensions as well as in foods, beverages and topical preparations.
DehydraTECH-CBD is a proprietary CBD formulation developed by the company based on its patented DehydraTECH drug-delivery technology.
Generic CBD is a complex fat-soluble molecule that reportedly has poor absorption characteristics. Typically only about 6% of orally ingested CBD finds its way into blood circulation, which drastically reduces its efficacy.
Lexaria says that DehydraTECH has demonstrated enhanced delivery of certain active molecules, including CBD into brain tissue, which it believes is of particular importance for the treatment of hypertension because of the significant influence of central mediation upon blood pressure.
The company says its research has proven up to 10 times increased absorption of orally administered CBD when it is processed with its technology.
Last year, Lexaria issued the results from its human clinical study HYPER-H21-2, confirming that CBD processed with DehydraTECH reduces arterial stiffness that is considered a precursor of many diseases, including hypertension, coronary heart disease, diabetes and renal disease, potentially broadening the scope of DehydraTECH-CBD’s application.
A possibly remarkable finding reported from the HYPER-H21-2 study was the ability of DehydraTECH-CBD to significantly reduce arterial stiffness with only a single day of dosing, prompting the company to initiate more thorough studies of its impacts during its five-week HYPER-H21-4 study this year.
“That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit,” said Chris Bunka, CEO of Lexaria Bioscience Corp.
“DehydraTECH also demonstrated excellent safety and tolerability results and no adverse changes in liver enzymes throughout the study. Consistent with Lexaria’s often-mentioned derisking strategy, this exceptional safety profile should prove beneficial as we prepare for our planned upcoming Phase Ib Investigational New Drug clinical study to be registered with the U.S. Food and Drug Administration.”
Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 27 patents granted for anti-viral drugs, cannabinoids including those for hypertension and central nervous system disorders, nicotine oral delivery, nonsteroidal anti-inflammatory drugs and vitamins. It has over 50 patents pending for other drugs and formulations.
For more information on Lexaria and its products, visit Lexaria’s website.
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