cGMP Manufacturing Complete for Lexaria's Upcoming U.S. Phase 1b Hypertension Clinical Trial

ACCESSWIRE · Lexaria Bioscience Corp.

In This Article:

  • DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations.

  • DehydraTECH-CBD has demonstrated exceptional safety and tolerability and a sustained decrease in blood pressure.

KELOWNA, BC / ACCESSWIRE / May 11, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that batch manufacturing of the DehydraTECH™-processed cannabidiol ("CBD") and placebo materials for its upcoming U.S. Phase 1b hypertension clinical trial HYPER-H23-1 has been completed.

Lexaria retained the services of a U.S. contract manufacturing organization to produce these materials compliant with current Good Manufacturing Practice ("cGMP") regulations as mandated by the Food and Drug Administration ("FDA"). Filling into capsules is expected to be completed this month, followed by analytical release and stability testing in order to gather essential quality control data necessary for Lexaria's upcoming Investigational New Drug ("IND") filing to the FDA, as previously agreed upon in last year's successful pre-IND meeting as announced on August 10, 2022.

Study HYPER-H23-1 is entitled ‘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'. The primary objective of the study 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.

Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within 60 days, resulting in the Phase 1b trial targeting commencement of patient dosing as early as October 2023.

Lexaria's five previous human clinical studies conducted from 2018 through 2022, which were not conducted under FDA-registration but are integral to successful filing and review of its upcoming IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations.

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