- Lexaria just announced the completion of batch manufacturing of its patented DehydraTECH(TM)-processed CBD and placebo materials for its FDA Phase 1b HYPER-H23-1 human clinical study
- This is in line with the company’s IND filing with the FDA, which it looks to complete this summer, with potential authorization within 60 days
- FDA authorization will mark the commencement of Phase 1b trial patient dosing, with the study evaluating the safety and tolerability of DehydraTECH-CBD in hypertensive patients
- Filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, announced an ambitious plan to embark on its Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study, HYER-H23-1. Earlier in May, the company announced the awarding of the contract for clinical research organization (“CRO”) services to California-based InClin, Inc. Since this announcement, it has completed batch manufacturing of its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) and placebo materials for the study (https://nnw.fm/1Q6lJ).
Lexaria retained the services of a U.S. contract manufacturing organization to produce these study materials, in line with current Good Manufacturing Practice (“cGMP”) regulations as directed by the FDA. With everything on track, the company looks to file the IND this summer, with potential authorization by the FDA within 60 days in what will mark the commencement of Phase 1b trial patient dosing, possibly in October 2023.
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,” Hyper-H23-1 will explore the safety and tolerability of its DehydraTECH-CBD in hypertensive patients. It will also monitor the efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing, building on the five previous human clinical studies which evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens with zero serious adverse events.
The filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted to gather essential quality control data essential for the IND filing. So far, DehydraTECH-CBD has shown the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics. In addition, none of the other published studies thus far have shown a sustained decrease in resting blood pressure following multiple weeks of oral CBD dosing, demonstrating DehydraTECH-CBD’s superior power to reduce blood pressure over other oral CBD formulations.
Finalized DehydraTECH-CBD batch manufacturing marks a significant step towards IND filing and subsequent FDA approval for Lexaria. It also marks a notable achievement for the company, especially given the multiple human clinical studies conducted since 2018 and the over 130 healthy and hypertensive persons that have taken part in the studies so far. Its management is optimistic about the HYPER-H23-1 clinical study and is confident that results from the company’s previous efforts will be replicated, if not exceeded.
For more information, visit the company’s website at www.LexariaBioscience.com.
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