Lexaria Awards CRO Contract for Upcoming U.S. Phase 1b Hypertension Study

ACCESSWIRE · Lexaria Bioscience Corp.

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Clinical study will evaluate safety and tolerability of Lexaria's patented DehydraTECH-CBD as a potential treatment for hypertension

California-based InClin to provide CRO services to manage and expedite the study

Lexaria is working with its regulatory and clinical advisors toward upcoming IND submission

KELOWNA, BC / ACCESSWIRE / April 24, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has awarded the contract for clinical research organization ("CRO") services for its expected upcoming Food and Drug Administration ("FDA")-registered, U.S. Phase 1b Investigational New Drug ("IND") hypertension study HYPER-H23-1 with its patented DehydraTECH-powered cannabidiol ("DehydraTECH-CBD") to California-based InClin, Inc.

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 120 hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.

InClin is about to begin study start-up and preparatory activities to enable Lexaria to "hit the ground running" with patient dosing as soon as possible after the expected FDA IND filing and review is completed. Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within about 60 days, resulting in the Phase 1(b) trial aggressively targeting commencement of patient dosing as early as October 2023.

The study start-up services to be provided by InClin include but are not limited to: clinical site evaluation and selection, personnel and site training, project management, clinical database design and management, quality assurance support, medical writing, study documentation creation, biostatistics and programming, support vendor coordination, Independent Review Board ("IRB") submissions and more.

Lexaria had a successful outcome following its FDA pre-IND meeting as announced on August 10, 2022. Since then, the Company has been working tirelessly with its regulatory and clinical advisors on refining the study plan and preparing for the IND submission pursuant to the pre-IND guidance it received from the FDA. The Company is in the process of performing the drug product manufacturing and stability testing required as part of the upcoming IND submission, compliant with current Good Manufacturing Practice ("cGMP") regulations. Assembling the stability data from its cGMP-manufactured batch production work is one of the last requirements prior to Lexaria submitting its formal IND application to the FDA this summer.

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