Lexaria Bioscience Corp. (Nasdaq: LEXX; LEXXW) has officially submitted its Investigational New Drug ("IND") application for the anticipated U.S. phase 1b hypertension clinical trial, HYPER-H23-1, featuring DehydraTECH-CBD, to the U.S. Food and Drug Administration ("FDA"). The submission, made on January 29, follows a successful pre-IND meeting with the FDA, providing valuable guidance for the development and filing process.

Lexaria conducted five investigator-initiated human clinical studies involving DehydraTECH-CBD, encompassing a total of 134 participants. Notably, these studies demonstrated significant reductions in resting blood pressure across acute and multi-week dosing regimens. Importantly, no serious adverse events were recorded during these studies, showcasing the potential broad therapeutic utility of DehydraTECH-CBD, either alone or in combination with standard care medications.

The FDA's standard 30-day waiting period post-IND submission allows for a safety review, ensuring that research subjects are not exposed to undue risks. Lexaria aims to initiate clinical trial HYPER-H23-1 promptly after the IND's effectiveness, contingent on certain conditions, including securing funding. Successfully concluding the IND review process will mark a crucial milestone for Lexaria, affirming that its DehydraTECH technology has met rigorous regulatory scrutiny, positioning it for potential future pharmaceutical commercial registration.

The upcoming clinical trial, HYPER-H23-1, is titled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension.' The trial's primary focus is on evaluating safety and tolerability in hypertensive patients, with secondary objectives encompassing efficacy evaluation for reducing blood pressure, coupled with comprehensive pharmacokinetic testing.

All aspects of study HYPER-H23-1, including clinical, laboratory, and analysis procedures, will be exclusively handled by U.S.-based, third-party independent contract service providers. This approach underscores Lexaria's commitment to ensuring rigorous and independent oversight throughout the trial process.

 

Source: lexariabioscience.com

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