Lexaria Bioscience Corp (NASDAQ:LEXX) () is expanding its applied research and development (R&D) program in 2021 with a particular focus on DehydraTECH-enabled CBD for hypertension, the company announced Thursday.
The company’s hypertension program now consists of five planned studies, three of which were previously announced on February 1 (HYPER-A21-1, HYPER-A21-2, and HYPER-H21-1). Study design for HYPER-A21-1 and HYPER-A21-2, both animal studies, has been completed, and dosing is expected to begin in late February or early March.
HYPER-H21-1, as well as new additions HYPER-H21-2 and HYPER-H21-3, are randomized, double-blinded human clinical studies that will take place in Europe, the company said. Study design for HYPER-H21-1 is complete, and university hospital and ethics board approvals have been received. Dosing will begin after shipment of the clinical test articles to the clinical site is completed, pending regulatory clearances.
READ: Lexaria Bioscience plots applied R&D course to DehydraTECH CBD hypertension and antiviral studies
HYPER-H21-2 is designed to monitor ambulatory blood pressure during the 24-hour period after dosing, with subjects wearing portable devices that will record blood pressure at 30-minute and 60-minute intervals. Volunteers will receive a 150mg dose of DehydraTECH-CBD or a placebo three times daily.
The company hopes that the results of this study will help it understand the effectiveness of DehydraTECH-processed CBD as a potential anti-hypertensive agent over a full day of monitoring, which complements the shorter-term monitoring in HYPER-H21-1. Study design for HYPER-H21-2 is complete and university hospital and ethics board approvals are pending.
HYPER-H21-3 is also a similar double-blinded, placebo-controlled, randomized human clinical study, but it is designed to measure a 300 mg dose of DehydraTECH-CBD on the blood pressure in volunteers under conditions of hypoxic pulmonary vasoconstriction, the company said.
Data from this study may show utility of DehydraTECH-CBD for blood pressure reduction in circumstances where pulmonary edema/hypertension occurs as a result of high-altitude travel, for instance.
Study design for HYPER-H21-3 is complete and university hospital and ethics board applications are under development and should be submitted shortly, the company said.
"Over 1.1 billion people suffer from hypertension," CEO Chris Bunka said in a statement. "Pending successful completion of Lexaria's study programs, we intend to pursue opportunities for growth through strategic partnerships with leading companies active in the hypertension drug or CBD pharmaceutical marketplaces."
Lexaria has received 18 granted patents internationally, the company said, including in the European Union and Australia, specifically to use DehydraTECH-processed CBD to treat heart disease.
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