HYPER-H21-4 using DehydraTECH-CBD evidenced:
KELOWNA, BC / ACCESSWIRE / October 27, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that human clinical study HYPER-H21-4 may be the world's first study to evidence a sustained drop in BP in normally active hypertensive patients following multiple weeks of oral cannabidiol ("CBD") therapy, using Lexaria's patented DehydraTECHTM-CBD capsule formulation.
The primary safety and efficacy objectives of study HYPER-H21-4 were successfully achieved. BP was significantly reduced by 2.5 weeks and was sustained over the full 5-weeks of dosing. These reductions in BP were achieved with zero serious adverse events being reported. Also, there were no adverse changes observed in liver enzymes; an important clinical safety biomarker of oral CBD therapy. Of note, these significant decreases in BP were achieved using relatively low doses of DehydraTECH-CBD as a direct result of the well-established drug delivery efficiencies of Lexaria's DehydraTECH technology.
In general, patients receiving placebo doses trended toward increases in BP during the period of the study compared to baseline, while the average BP measured by each of mean arterial BP ("MAP"), systolic BP ("SBP") and diastolic BP ("DBP") significantly decreased from baseline when dosed with DehydraTECH-CBD; and those decreases were maintained during the full 5 weeks of dosing. In fact, as shown in the table below, as much as a 7.01 mmHg differential in SBP was evidenced comparing the average SBP reduction from baseline on DehydraTECH-CBD to the average SBP increase from baseline upon cross-over on placebo following the second 2.5 weeks of dosing. Furthermore, there appeared to be a trend toward greater BP reduction over time and at the higher doses employed in the second 2.5 weeks of dosing; an important factor to be explored in future studies.
24-Hour BP Monitoring Change from Baseline | Dose Period 1 First 2.5 Weeks (mmHg) | Dose Period 2 Second 2.5 Weeks (mmHg) | ||
DehydraTECH-CBD (225 mg - 300 mg daily) | Placebo | DehydraTECH-CBD (375 mg - 450 mg daily) | Placebo | |
MAP | -3.22 +/-0.90 P =0.002 | +0.72 +/-0.78 P =1.000 | -4.14 +/-0.69 P | |