- Lexaria just completed dosing for its HYPER H21-4 human clinical study that dosed 64 patients aged between 40 and 70 with measured elevated blood pressure, stage 1 and stage 2 hypertension
- HYPER-H21-4, Lexaria’s most ambitious hypertension clinical study yet, builds on the success of HYPER-H21-1 and HYPER-H21-2, both completed in 2021
- It explores the use of the company’s patented DehydraTECH(TM) technology in the potential treatment of hypertension
- Lexaria is confident that the additional data sets collected over the course of the study will lead to supplementary applications for DehydraTECH while providing valuable additional insights into the long-term health benefits of this compound that might otherwise remain undetected
In November 2021, Lexaria Bioscience (NASDAQ: LEXX) announced its most ambitious hypertension study yet, HYPER-H21-4. The goal of the study, according to Lexaria’s Chief Executive Officer (“CEO”), Chris Bunka, was to “Support the company’s goals related to pursuit of regulatory approvals for DehydraTECH-CBD for potential use as a treatment for high blood pressure,” (https://ibn.fm/MKysj).
At the close of the year, Lexaria received independent Review Board (“IRB”) approval ahead of schedule, which marked a significant milestone for the company. It would set the stage for the commencement of the study in the year 2022 while allowing Lexaria to explore the full potential of its patented DehydraTECH(TM) technology in hypertension treatment (https://ibn.fm/7DSdQ).
On July 27, 2022, Lexaria announced that dosing with DehydraTECH-processed cannabidiol (“DehydraTECH-CBD”) had been completed in a multi-week human clinical hypertension study. Most notably, no serious adverse events were reported due to the dosing: the absence of serious adverse events is a critical goal of typical Phase I and Phase II FDA-registered studies Furthermore, the whole undertaking was completed on schedule, another huge milestone for the company as it works towards enhancing its understanding of DehydraTECH-CBD and its effectiveness in treating cardiovascular and other disease states beyond hypertension (https://ibn.fm/jCJFy).
“We are extremely pleased that dosing has been completed on time in this multi-week clinical study without any serious adverse events having occurred,” noted Mr. Bunka.
“Demonstrating a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications is one of Lexaria’s major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations,” he added.
This HYPER-H21-4 study consisted of male and female volunteers aged between 40 and 70. These volunteers had documented or measured elevated blood pressure, mild (stage 1) hypertension, to moderate (stage 2) hypertension. They received DehydraTECH-CBD every day for five weeks, with the doses escalating between 225 mg/day to 450 mg/day over the study duration, adjusted relative to body weight.
The study’s extended duration allowed Lexaria to collect critical data monitoring the safety and efficacy of its DehydraTECH-CBD over time. This allowed the company to evaluate the potential for longer health benefits. Some of the study outcomes include vascular health, incorporating arterial stiffness and autonomic balance, electrocardiogram (“ECG”) analysis, brain structure and function through MRI testing, and blood biomarkers, among others.
Lexaria is confident that each of these data sets will lead to additional applications for DehydraTECH-CBD while also providing valuable additional insights into the long-term health benefits of this compound that might otherwise remain undetected. Analysis of most of the data collected since the beginning of the study has begun and results should begin to be released in September 2022, with additional results to be release subsequently.
HYPER-H21-4 builds on HYPER-H21-1 and HYPER-H21-2 studies, all conducted in 2021. Both of these previous studies evidenced a rapid and sustained drop in blood pressure with DehydraTECH-CBD in what Mr. Bunka described as “encouraging early results.” As a result, Lexaria is optimistic that with the success of its latest study, its DehydraTECH-CBD will offer a better alternative to existing hypertension drugs in the market, mostly known for their unwanted side effects once approved.
For more information, visit the company’s website at www.LexariaBioscience.com.
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