New York, N.Y., March 01, 2024 - PRISM MarketView - Lexaria Bioscience (Nasdaq: LEXX) continues to advance its CBD-based candidate for hypertension with the clearance of its investigational new drug (IND) application by the FDA this week. The company is now planning to initiate a Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD in the US.
“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."
Lexaria’s President, John Docherty
“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’s President, John Docherty
Highlights
The primary objective of Lexaria’s Phase 1b trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
Lexaria has previously conducted five human clinical studies of DehydraTECH-CBD in 134 healthy and hypertensive volunteers which demonstrated significant reductions in resting blood pressure across dosing regimens.
DehydraTECH-CBD is unique in its superior power to reduce blood pressure over other oral CBD formulations, and it has demonstrated an excellent safety profile, to date.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 39 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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