New York, January 31, 2024 - PRISM MarketView - Global drug delivery innovator, Lexaria Bioscience (Nasdaq: LEXX) has taken an important step forward in its hypertension program after submitting an Investigational New Drug (IND) application to the FDA today. The company is planning a Phase 1b clinical trial to evaluate the role of DehydraTECH-CBD in the treatment of hypertension.
Lexaria has sponsored a total of five investigator-initiated human clinical studies of its DehydraTECH-CBD in 134 participants, demonstrating significant reductions in resting blood pressure over both acute and multi-week dosing regimens both alone and along with standard of care medications; suggesting that DehydraTECH-CBD has the potential to have broad therapeutic utility. In these studies, DehydraTECH-CBD was found to be safe and well-tolerated with no serious adverse events reported.
The company has entered the 30-day waiting period required by the FDA before initiating its clinical trial. Lexaria says that it looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding.
The primary objective of the 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.
About Lexaria and 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 38 patents granted and many patents pending worldwide.
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Phone: 646-863-6341
Website: https://prismmarketview.com
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