Lexaria’s Human Clinical HYPER-H21-4 Study

HYPER-H21-4 using DehydraTECH-CBD evidenced:

• Exceptional safety and tolerability
• Statistically significant lowering of 24-hour ambulatory blood pressure (“BP”)
• BP lowered for the entire 5-week study duration
• BP lowered both for patients currently taking other antihypertensive drugs as well as patients not taking any other antihypertensive drugs

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.

Other published research has established that, in order to reduce the collective risk of cardiovascular events such as myocardial infarction, stroke and congestive heart failure, reductions in BP of ~4.6 mmHg for SBP and ~2.2 mmHg for DBPare required. Lexaria’s DehydraTECH-CBD BP reductions exceed these crucial levels.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting BP is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce BP over other oral CBD formulations.

“That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit,” said Chris Bunka, CEO of Lexaria Bioscience Corp. “DehydraTECH also demonstrated excellent safety and tolerability results and no adverse changes in liver enzymes throughout the study. Indeed, of the handful of minor, non-serious adverse events reported, there were nearly as many reported by those patients receiving placebo as those who received DehydraTECH-CBD. Consistent with Lexaria’s often-mentioned de-risking strategy, this exceptional safety profile should prove beneficial as we prepare for our planned upcoming Phase Ib Investigational New Drug clinical study to be registered with the U.S. Food and Drug Administration.”

Another important discovery from study HYPER-H21-4 was that the decreases in BP were similar in persons currently being treated with standard of care BP medications as in persons who were not undergoing any current standard of care BP treatment. This observation is suggestive that Lexaria’s DehydraTECH-CBD has the potential to offer additive BP reduction benefits on top of any degree of improvements the standard of care medications achieved for those patients before entry into the study. This additive improvement as an adjunct therapy, together with the exceptional safety profile of DehydraTECH-CBD, could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment.

Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon in due course as these findings become available, currently expected during the remainder of 2022. The current findings will be submitted to an appropriate peer-reviewed clinical hypertension journal for possible publication.

ABOUT THE STUDY.

Study HYPER-H21-4 was a randomized, double-blinded, placebo-controlled, cross-over study that consisted of male and female volunteers between the ages of 40-70. Sixty-six (66) people were ultimately dosed to completion of the study, and they had 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).

All study participants received DehydraTECH-CBD every day for a 5-week duration in the dose-escalating 2.5 week increments noted above. Upon cross-over and wash out, all 66 study participants also received the matching placebo for a 5-week duration following the study randomization schedule. Thirty-three (33) of these patients had been diagnosed with hypertension but were not being treated with any antihypertensive medications, while 33 patients had been diagnosed with hypertension and were receiving commonly used antihypertensive therapies including angiotensin-converting enzyme (“ACE”) inhibitors with or without diuretics; or alternatively, ACE inhibitors with calcium channel blockers. The complete study protocol has already been published and is available at PubMed.