Lexaria Bioscience Appoints CRO; Prepares for Investigational New Drug (IND) Application Submission
Lexaria Bioscience (Nasdaq: LEXX) has awarded a contract for clinical research organization (CRO) services to California-based InClin, Inc. as the company prepares to submit an Investigational New Drug (IND) application to the FDA.
InClin will provide CRO services to manage and expedite Lexaria’s expected upcoming FDA-registered Phase 1b hypertension study. The study will evaluate safety and tolerability of Lexaria’s patented DehydraTECH-CBD as a potential treatment for hypertension.
Highlights
Study HYPER-H23-1 will evaluate DehydraTECH-CBD in 120 hypertensive patients, including safety, tolerability and efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
The company’s five previous human clinical studies have evidenced significant reductions in resting blood pressure with zero serious adverse events suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.
Lexaria anticipates filing its IND this summer and is targeting an October 2023 start date for patient dosing.
About Lexaria
Lexaria Bioscience’s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients enter the bloodstream through oral delivery. DehydraTECH has demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide.
