New York, March 01, 2024 - PRISM MediaWire - Lexaria Bioscience (Nasdaq: LEXX) has made significant strides in advancing its CBD-based candidate for hypertension, marked by the recent clearance of its investigational new drug (IND) application by the FDA. With this regulatory milestone achieved, the company now gears up to launch a Phase 1b hypertension clinical trial, designated as HYPER-H23-1, utilizing its proprietary DehydraTECH-CBD technology in the United States.
Commenting on the IND clearance, Lexaria’s President, John Docherty, emphasized the significance of this achievement, stating, “This marks a pivotal milestone for Lexaria, demonstrating the capability of our DehydraTECH technology to meet the rigorous regulatory standards set by the FDA, thereby enabling the formal initiation of U.S. registrational clinical trials aimed at potential pharmaceutical commercialization in the future."
“We are eagerly anticipating the commencement of this crucial clinical trial and are poised to leverage the extensive early-stage clinical data we have presented to the FDA thus far, showcasing the safety, efficacy, and innovative mechanistic performance of DehydraTECH-CBD in hypertensive patients.”
Key Points:
- The primary focus of Lexaria’s Phase 1b trial will be to assess the safety and tolerability of the intervention in hypertensive patients, with secondary objectives including the evaluation of efficacy in reducing blood pressure, alongside comprehensive pharmacokinetic assessments.
- Prior to this Phase 1b trial, Lexaria has conducted five human clinical studies involving DehydraTECH-CBD, encompassing 134 healthy and hypertensive volunteers. These studies have consistently demonstrated significant reductions in resting blood pressure across various dosing regimens.
- DehydraTECH-CBD stands out due to its superior efficacy in reducing blood pressure compared to other oral CBD formulations, coupled with its excellent safety profile documented thus far.
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