- Lexaria intends to undertake its most ambitious study yet – HYPER-H21-4 – as it pursues regulatory approval for DehydraTECH-CBD for potential use as a treatment for hypertension
- HYPER-H21-4 will build on successes witnessed in initial human hypertension studies
- The company, which has a fully funded R&D budget, recently announced new R&D programs covering multiple conditions, including dementia, diabetes, and rheumatoid disease
- Lexaria is committed to improving lives and lessening deaths through its patented DehydraTECH(TM) technology
With a fully-funded research and development (“R&D”) budget, Lexaria Bioscience (NASDAQ: LEXX), a global leader in enhancing the speed, efficacy, bioavailability, and brain absorption of orally-delivered fat-soluble active pharmaceutical ingredients (“APIs”) through its patented DehydraTECH(TM) drug delivery technology is embarking on new programs as well as extending ongoing ones as it pursues regulatory approvals and entry into different market sectors.
In January 2022, Lexaria expects to report blood pressure findings from its third human hypertension study, HYPER-H21-3, building on the successes of the first two human studies, HYPER-H21-1 and HYPER-H21-2, that evidenced effective, sustained, and safe blood pressure reduction with DehydraTECH-CBD.
The company will also be expecting approval from the Independent Review Board (“IRB”) for the study protocols around its fourth hypertension study. Described as the most ambitious study Lexaria has ever undertaken, HYPER-H21-4 will comprise 60 volunteers aged between 45 and 70 years, some of whom will be given three 150 mg doses of DehydraTECH-CBD daily for six weeks, while a subset will be given a placebo control. The extended duration is intended to enable the company to collect important data by monitoring the prolonged use of DehydraTECH-CBD and will investigate the potential for longer-term health benefits.
“Outcomes from this study could support Lexaria’s goals related to pursuit of regulatory approvals for DehydraTECH-CBD for potential use as a treatment for high blood pressure,” said Lexaria CEO Chris Bunka in a recent press release (https://cnw.fm/J6rS9).
Notably, HYPER-H21-4 is just one of the many planned studies slated for 2022. Others include HOR-A22-1, a pharmacokinetic (“PK”) study to evaluate DehydraTECH’s ability to improve the delivery characteristics of estrogen; DEM-A22-1, an efficacy modeling study to evaluate DehydraTECH-CBD with and without nicotine for the potential treatment of dementia; RHEUM-A22-1, an efficacy modeling study to investigate the ability of DehydraTECH-CBD to potentially affect the treatment of rheumatoid disease; and DIAB-A22-1, an efficacy modeling study to explore DehydraTECH-CBD’s ability to potentially impact treatment of diabetes (https://cnw.fm/EC2IH).
In addition to fulfilling Lexaria’s goal to enter into new, different multi-billion-dollar markets, the four animal studies will mark the company’s push to help patients living with these conditions, some of which are potentially fatal.
According to the World Health Organization (“WHO”), diabetes was the ninth leading cause of deaths globally in 2019, having claimed an estimated 1.5 million lives (https://cnw.fm/qqg8S). Additionally, WHO ranks dementia as the seventh leading cause of death among all diseases and a primary cause of dependency and disability, majorly among the elderly (https://cnw.fm/gsK1h).
As a versatile solution with multiple benefits, DehydraTECH is protected by a robust portfolio of 23 granted patents (currently) and more than 50 pending patents. The technology works by combining APIs with long chain fatty acid oils such as high oleic sunflower oil. The product is then added to food/carrier particles before undergoing a dehydration synthesis procedure. The final step entails rendering the final form factor of the drug as a liquid or powder.
According to Lexaria, “DehydraTECH works symbiotically with existing physiological systems to enable improved and more rapid absorption into the bloodstream and brain tissues” (https://cnw.fm/KUEBt).
Through its focus on improving how APIs enter the bloodstream by promoting healthier delivery methods, Lexaria remains committed to improving lives and lessening deaths associated with heart disease, cigarette smoking, and, with the new R&D programs, diabetes, dementia, and more.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX
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