The US Food and Drug Administration (FDA) has granted clearance for Lexaria Bioscience’s investigational new drug (IND) application to commence the Phase Ib clinical trial, HYPER-H23-1, of DehydraTECH-CBD to treat hypertension.
A drug delivery formulation and processing platform technology of Lexaria, DehydraTECH-CBD is claimed to boost the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery.
The upcoming double-blind, randomised, placebo-controlled study will assess the safety, pharmacokinetics, and pharmacodynamics of DehydraTECH-CBD in individuals with Stage I or Stage II hypertension.
Assessing the tolerability and safety of the treatment in hypertensive patients is the trial’s primary goal.
The efficacy of DehydraTECH-CBD in reducing blood pressure and detailed pharmacokinetic testing are the secondary objectives of the trial.
Lexaria plans to make further announcements regarding the commencement of the trial, which is contingent on securing adequate funding.
Between 2018 and 2022, Lexaria conducted five human clinical trials involving DehydraTECH-CBD in 134 healthy and hypertensive subjects.
These studies did not record any serious adverse events and indicated a substantial decline in resting blood pressure across acute and multi-week dosing regimens.
Notably, results from Lexaria’s study dubbed HYPER-H21-4 revealed a potentially new mechanism of action of DehydraTECH-CBD in reducing blood pressure, which may be partially explained by its interaction with the human sympatho-chromaffin system through catestatin modulation.
Lexaria president John Docherty said: “This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA's high level of regulatory scrutiny sufficient to formally commence US registrational clinical testing towards possible future pharmaceutical commercialisation.
“We look forward to commencing this important clinical trial and building upon the wealth of early-stage clinical data we have gathered and presented to the FDA to date, demonstrating the safety, efficacy and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients.”
