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
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.
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.