- Lexaria just announced additional findings from its HYPER-H21-4 human clinical study, highlighting significant reductions in several pro-inflammatory biomarkers associated with cardiovascular disease
- This has been termed as “the most convincing evidence in humans,” ultimately showcasing the potential of the company’s patented DehydraTECH(TM)-processed CBD
- Other third-party research studies have failed to demonstrate a sustained decrease in resting blood pressure with oral CBD dosing. More so, none have yielded evidence of the anti-inflammatory actions of CBD until Lexaria’s HYPER-H21-4 human clinical study
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently announced additional findings from its HYPER-H21-4 human clinical study that sought to explore the potential of its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) in reducing blood pressure (“BP”). Of note was the demonstration of significant reductions in several pro-inflammatory biomarkers associated with cardiovascular disease (“CVD”) in what was described as “the most convincing evidence in humans” of the anti-inflammatory actions of CBD.
“There is some pre-clinical evidence for the anti-inflammatory actions of CBD, but this is likely the most convincing evidence in humans that I have ever seen,” noted Dr. Philip Ainslie, Cardiovascular Advisor to Lexaria and Lead Investigator of Study HYPER-H21-4 (https://ibn.fm/Cx0nx).
This finding adds to the success of the ambitious HYPER-H21-4, which successfully met all primary efficacy and safety objectives, with resting BP showing a significant reduction among hypertensive patients. Furthermore, this reduction in BP was sustained over a full 5-weeks of dosing, with no serious adverse events reported. This built on the findings from the four previous human clinical studies conducted from 2018 to 2022, all of which have paved the way for Lexaria’s anticipated U.S. Food and Drug Administration (“FDA”) HYPER-H23-1 clinical study, its most ambitious yet.
Titled “A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension,” HYPER-H23-1 looks to build on all previous studies conducted by Lexaria thus far. It also plays an integral role as a lead-up to IND filing this summer, with hopes for FDA authorization within 60 days after that.
So far, only a handful of other research studies have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing. However, none have been successful at achieving it. More so, none have yielded evidence of the anti-inflammatory actions of CBD, which shows the potential of Lexaria’s DehydraTECH-CBD.
For more information, visit the company’s website at www.LexariaBioscience.com.
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