CBD Therapy Lowers Arterial Blood Pressure in PH-mimicking Conditions
Treatment with DehydraTECH-CBD, Lexaria Bioscience’s investigational cannabis-derived treatment for pulmonary hypertension (PH), led to reduced pulmonary artery pressure in healthy volunteers who were exposed to low oxygen levels — especially among male participants — in conditions that mimicked PH.
This was according to data from the now-completed HYPER-H21-3 clinical study, Lexaria noted in a press release.
DehydraTECH-CBD is an oral formulation of cannabidiol (CBD) — a non-psychoactive chemical derived from the cannabis plant. The treatment employs Lexaria’s DehydraTECH drug delivery technology, which is designed to improve the body’s ability to absorb CBD, especially in the brain.
PH is characterized by an increased blood pressure in the pulmonary arteries, or those suppling blood to the lungs. The aim of the trial was to safely mimic the condition in healthy volunteers, in order to assess the potential efficacy of DehydraTECH-CBD treatment.
To do so, 16 healthy volunteers (eight females and eight males), ages 18–35, received a single 300 mg dose of the therapy or a placebo followed by a 30-minute rest period in normal air (21% oxygen). After this, participants were subjected to 40 minutes of hypoxia, or low oxygen (12%).
Low oxygen is known to cause hypoxic pulmonary vasoconstriction — a condition in which the pulmonary arteries constrict to divert blood flow and improve ventilation. A consequence of the condition is an acute state of pulmonary hypertension.
Echocardiography — a technique used to image the heart — measured pulmonary artery pressure after 15 and 30 minutes of low oxygen.
Results showed a trend toward reduced artery pressure after treatment compared with a placebo, according to Lexaria. This effect was markedly more significant among the male participants, in whom a 41% overall reduction in pressure was observed with treatment compared with the placebo.
The results suggest “differences by sex in responsiveness to CBD treatment under hypoxic stress conditions,” Lexaria stated.
These results join a growing body of clinical evidence that shows an ability for DehydraTECH-CBD to reduce blood pressure, including in both general hypertension and stress-induced pulmonary hypertension conditions, the company stated.
A previous study, HYPER-H21-2, showed that three 150 mg doses of the treatment over one day could reduce arterial stiffness — a characteristic of several cardiovascular conditions, including PH — among people with general hypertension.
No serious side effects were observed in either study, Lexaria noted.
“These new findings from HYPER-H21-3 will help direct prospective future research into the efficacy of DehydraTECH-CBD use for the management of elevations in pulmonary arterial pressure under hypoxic conditions (e.g., exposure to altitude), related hypoxemic pathologies (e.g., severe lung disease), and pulmonary hypertension,” Lexaria stated.
These promising data will be used to seek approval from the U.S. Food and Drug Administration for formal clinical testing under an investigational new drug application, Lexaria reported.
Late last year, Lexaria announced it had received institutional approval for an additional study, HYPER-H21-4, which would consist of 60 adult volunteers who would be treated with 150 mg of daily DehydraTECH-CBD or a placebo for six weeks.
That trial would evaluate blood pressure, artery stiffness, brain structure, and function through MRI imaging, stress, and anxiety — among several other measures. As of the last update from Lexaria, dosing for that study was expected to begin in April this year.
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