Lexaria Announces FDA Clearance for its Planned U.S. Phase 1b Hypertension Clinical Trial

KELOWNA, BC / ACCESSWIRE / March 1, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that the U.S. Food and Drug Administration ("FDA") has confirmed effectiveness as of February 28, 2024 of the Company's investigational new drug ("IND") application thereby cleared for Lexaria to conduct its planned U.S. Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD.

"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 U.S. registrational clinical testing towards possible future pharmaceutical commercialization," said John Docherty, president of Lexaria. "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."

Lexaria is pleased to have complied with the FDA's rules and procedures for clearance to perform this important registrational trial. The Company will further announce when it is ready to begin the study, subject to certain conditions including raising sufficient funding.

Background and Medical/Market Rationale

From 2018 through 2022, Lexaria has previously conducted five human clinical studies of DehydraTECH-CBD in an aggregate total of 134 healthy normal and hypertensive volunteers, without recording a single serious adverse event (the "Studies"). The Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations.