KELOWNA, British Columbia - Lexaria Bioscience (NASDAQ:LEXX) Corp. (NASDAQ: LEXX; LEXXW), specializing in drug delivery platforms, has received the green light from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 1b clinical trial for hypertension treatment using its proprietary DehydraTECH-CBD technology.
The approval, effective as of February 28, 2024, allows the company to begin its U.S. clinical trial, named HYPER-H23-1, aimed at evaluating the safety and efficacy of DehydraTECH-CBD in patients with stage 1 or stage 2 hypertension.
The company's president, John Docherty, expressed that this clearance marks a significant milestone for Lexaria as it demonstrates that their DehydraTECH technology meets the FDA's rigorous regulatory standards for initiating U.S. registrational clinical testing, potentially leading to pharmaceutical commercialization.
Lexaria has conducted five human clinical studies from 2018 to 2022, involving 134 healthy and hypertensive volunteers, which indicated that DehydraTECH-CBD could significantly reduce resting blood pressure without recording any serious adverse events. These findings suggest that DehydraTECH-CBD could offer pronounced clinical benefits compared to existing anti-hypertensive therapeutics.
The company highlighted a study, HYPER-H21-4, which suggested a potentially novel mechanism of action for DehydraTECH-CBD in blood pressure reduction, possibly through its interaction with the human sympatho-chromaffin system. The FDA has previously outlined the need for new anti-hypertensive drugs that provide novel and complementary modes of action, which Lexaria believes its technology fulfills.
The upcoming trial, HYPER-H23-1, will be a randomized, double-blind, placebo-controlled study focusing on the safety, pharmacokinetics, and pharmacodynamics of DehydraTECH-CBD. Lexaria will announce the commencement of the study once funding and other conditions are met.
DehydraTECH is Lexaria's patented drug delivery formulation, which has shown to improve the bio-absorption of active pharmaceutical ingredients and the ability to deliver drugs more effectively across the blood-brain barrier. The company maintains a robust intellectual property portfolio with 39 patents granted and numerous pending globally.
This article is based on a press release statement from Lexaria Bioscience Corp. and does not include any forward-looking statements or claims from the company. The factual information presented is intended to inform readers about the FDA's approval for Lexaria to conduct its clinical trial on DehydraTECH-CBD for hypertension treatment.
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