- 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…
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