Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced that it has begun its multi-week human clinical hypertension study. The randomized, double blinded, placebo-controlled, cross-over study in 60 people, HYPER-H21-4, is the most comprehensive study ever undertaken by Lexaria. HYPER-H21-4 is designed to enhance Lexaria’s probability of success with its expected subsequent Investigational New Drug (“IND”) application filing to seek U.S. Food and Drug Administration (“FDA”) approval to commence registered clinical testing at phase I level or higher, to be determined in consultation with the FDA. The human study is also expected to enhance Lexaria’s understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension. Dosing has commenced in more than half of the HYPER-H21-4 volunteers, ahead of schedule, with all treatment visits expected to conclude in early July 2022. In addition, baseline brain magnetic resonance imaging (“MRI”) scanning has already begun. Of significant note, no serious adverse events have been reported by study volunteers, demonstrating that DehydraTECH-CBD has been well tolerated in those who have received it thus far.
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About Lexaria Bioscience Corp.
Lexaria’s patented drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 – 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (“NSAIDs”), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 24 patents granted and over 50 patents pending worldwide. For more information, visit the company’s website at www.LexariaBioscience.com.
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