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 / 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.
Lexaria's five previous human clinical studies conducted from 2018 through 2022, which were not conducted under FDA-registration but are expected to be 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.
Findings from Lexaria's latest study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in the peer-reviewed and published respected journal, " Biomedicine and Pharmacotherapy ". This is of significance because the FDA has previously laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reduction benefits on top of any degree of improvements that standard of care medications achieved for patients prior to DehydraTECH-CBD dosing.
About DehydraTECH-CBD
DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.
About InClin, Inc.
InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. They are a single source provider of an integrated full suite of clinical development services from Phase 1 to Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, and strategic consulting services. InClin has assembled a team of seasoned professionals and vendor service providers who will support study HYPER-H23-1 for Lexaria, with extensive expertise and experience in the core areas relevant for this program including cardiac safety and efficacy monitoring and pharmacokinetic testing. For more information visit www.InClin.com.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
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