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- Lexaria just awarded InClin, Inc. the contract for CRO services, in a move that lines up with the company’s upcoming FDA-registered, U.S. Phase 1b IND hypertension study, HYPER-H23-1
- InClin will manage the study in the form of clinical site evaluation and selection, project management, personnel, site training, and more
- Patient dosing is set to kick off as soon as possible once the expected FDA IND filing and review is completed, which Lexaria hopes will be done this summer
- HYPER-H23-1 will be Lexaria’s most ambitious study yet, and upon its completion, it will move the company closer to FDA approval of its patented DehydraTECH(TM)-processed CBD
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced the awarding of the contract for clinical research organization (“CRO”) services to California-based InClin, Inc. This move is in line with the company’s upcoming Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study, HYPER-H23-1 that will explore the potential of its patented DehydraTECH(TM)-processed cannabidiol (“DehydraTECH-CBD”) for the treatment of hypertension (https://cnw.fm/8WGqS).
The study will build on five previous Lexaria studies dating back to 2018, which were each successful, evidencing significant reductions in resting blood pressure over acute and multi-week dosing regimens on 134 healthy and hypertensive persons. The studies also showed that DehydraTECH-CBD produced zero serious adverse events, highlighting its potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics. The uniqueness of this product is further evidenced by its superior ability to reduce blood pressure over other oral CBD formulations currently in the market.
InClin will help with the study in the form of clinical site evaluation and selection, project management, personnel, site training, clinical database design and management, and quality assurance support. It will also be responsible for medical writing, study documentation creation, biostatistics and programming, support vendor coordination, Independent Review Board (“IRB”) submissions, and more. Study start-up is about to begin, with patient dosing set to kick off as soon as the expected FDA IND filing and review is completed, which Lexaria hopes will be done this summer. Upon the filing, Lexaria hopes for FDA authorization within about 60 days, after which the Phase 1(b) trial aggressively targeting the commencement of patient dosing will kick off.
HYPER-H23-1, titled “A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension,” will be Lexaria’s most ambitious study yet. Its primary objective will be to evaluate safety and tolerability in up to 120 hypertensive patients, with secondary objectives including efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing. Its successful completion will inch Lexaria closer to FDA approval of its DehydraTECH-CBD. But, more importantly, it will stamp Lexaria’s position as a leader in its space, having come up with a product that achieves a sustained decrease in resting blood pressure following multiple weeks of oral CBD dosing.
For more information, visit the company’s website at www.LexariaBioscience.com.
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