Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to announce that it has begun its multi-week human clinical hypertension study.
The study, HYPER-H21-4, is a randomized, double blinded, placebo-controlled, cross-over study in 60 people and the most comprehensive study ever undertaken by Lexaria. Dosing in more than half the volunteers has already commenced ahead of schedule, with all treatment visits expected to conclude in early July, 2022. Baseline brain magnetic resonance imaging (“MRI”) scanning has also already begun. Of significant note, there have been no serious adverse events reported by these volunteers, demonstrating that DehydraTECH-CBD has been well tolerated in those that have received it thus far.
HYPER-H21-4 is designed to enhance Lexaria’s probability of success with its expected subsequent Investigational New Drug (“IND”) application filing to seek Food and Drug Administration (“FDA”) approval to commence registered clinical testing at the Phase I level or higher, to be determined in consultation with the FDA. This human study is also expected to enhance Lexaria’s understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension related to increased arterial stiffness, pursuant to earlier promising findings in this area. HYPER-H21-4 follows Lexaria’s previously announced successes in significantly reducing blood pressure in similarly hypertensive human volunteers in its 2021 studies HYPER-H21-1 and HYPER-H21-2.
This study is entirely funded through the Company’s existing cash resources and is not subject to any financing requirement. Independent Review Board approval was received in December 2021. The clinical test articles for this study have been manufactured, quality control tested and shipped to the European research hospital conducting the study.
HYPER-H21-4 consists of a minimum of 60 volunteers between the ages of 40-70 with documented or measured elevated blood pressure (120/80 to 139/80 mmHg), mild (stage 1) hypertension (140/90 to 159/99 mmHg) or moderate (stage 2) hypertension (160/100 to 179/109 mmHg) who will use DehydraTECH-CBD every day for a 5-week duration. DehydraTECH-CBD doses will escalate between a range of 225 mg/day to 450 mg/day over the study duration. Some volunteers will already be using leading standard of care hypertension drugs such as angiotensin-converting enzyme (“ACE”) inhibitors with or without diuretics and/or calcium channel blockers, which will help evaluate the efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study will allow Lexaria to gather critical data monitoring the safety and efficacy of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.
HYPER-H21-4 is more comprehensive than any work previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure, which is the primary study outcome.
Secondary study outcomes include: vascular health including arterial stiffness and autonomic balance; electrocardiogram (“ECG”) analysis; brain structure and function through MRI testing; blood biomarkers (including lipids such as cholesterol and more); renal and hepatic analysis, sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. Each of these sets of data may lead to additional applications for DehydraTECH-CBD. For example, the MRI data may assist one of the secondary outcome measurements in the study to evaluate possible positive effects upon brain structure and function; and the detailed psychometric testing may reveal new insights into the potential benefits for mental health. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.
Lexaria will provide further updates on the progress of study HYPER-H21-4 and its IND application enabling program as they become available. Details on the outcomes after the expected July conclusion of all treatment visits in study HYPER-H21-4 will follow in due course after performing the necessary data analyses.
