Lexaria's Clinical Hypertension Study HYPER-H21-3 Nears Completion

Rhea-AI Summary

Lexaria Bioscience Corp. (NASDAQ:LEXX, LEXXW) announces the near completion of its human clinical study HYPER-H21-3, which is exploring the effects of DehydraTECH-CBD on acute pulmonary hypertension. The study involved a placebo-controlled trial with 16 volunteers receiving a 300mg dose of DehydraTECH-CBD. Blood samples are currently being analyzed, with results expected soon. This research aims to contribute to the understanding of DehydraTECH-CBD as a treatment for hypertension and will be submitted to the FDA as part of their investigational drug research program.

Positive

• Completion of dosing and sample collection in clinical study HYPER-H21-3.
• Study aimed to evaluate DehydraTECH-CBD's effect on pulmonary vascular function.
• Results to be reported soon and potentially submitted to regulators like the FDA.

Negative

• The effectiveness of CBD as a treatment for pulmonary hypertension is still unknown.
• There are inherent risks and uncertainties in achieving intended research results.

KELOWNA, BC / ACCESSWIRE / December 14, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its human clinical study HYPER-H21-3 is expected to complete all dosing and sample collection this week.

Formal hospital and ethics board approvals for human clinical study HYPER-H21-3 had been received in March. Study HYPER-H21-3 used a placebo-controlled and blinded design, with administration of a single 300mg dose of a specific DehydraTECH 2.0 CBD formulation compared to placebo in a target group of sixteen enrolled volunteers. This "Stress Test" study was undertaken to examine the effects of DehydraTECH-CBD upon acute pulmonary hypertension. Blood samples collected from this study will be subjected to analysis and the blood pressure results are expected to be reported soon.

Exposure to acute reductions in oxygen tension (i.e., hypoxia) causes rapid hypoxic pulmonary vasoconstriction (HPV) and, as a consequence of this HPV response, pulmonary arterial pressure increases. If this increase in pressure becomes too high, as is the case in many cardiac pathologies, an excess of fluid in the lungs can occur that causes difficulty with breathing.

The extent to which CBD may act as a novel treatment for HPV, and potentially as an alternative treatment for pulmonary hypertension, is unknown. Thus, the primary objective of this study is to evaluate the effect of DehydraTECH-CBD on pulmonary vascular function in normotensive individuals exposed to hypoxia. The magnitude of HPV, blood pressure, heart rate, blood samples and pulmonary gas exchange data is being collected and analysis is ongoing.

Results from study HYPER-H21-3 are expected to add to Lexaria's growing body of evidence for the effectiveness of DehydraTECH-CBD against hypertension, and will be submitted to regulators such as the FDA, as the Company pursues its planned investigational new drug research program. Lexaria offers its gratitude to the teams of experts conducting its series of three human clinical studies through 2021 overwhelmingly on schedule and on budget particularly during the past year when challenges from the COVID-19 epidemic were pronounced.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), 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 23 patents granted and over 50 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. 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 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

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FAQ

What is the purpose of Lexaria's clinical study HYPER-H21-3?

HYPER-H21-3 aims to evaluate the effect of DehydraTECH-CBD on pulmonary vascular function in individuals exposed to hypoxia.

When will the results from the HYPER-H21-3 study be available?

Results from the HYPER-H21-3 study are expected to be reported soon, following the completion of sample analysis.

What is the significance of DehydraTECH-CBD in treating hypertension?

DehydraTECH-CBD is being researched for its potential effectiveness against hypertension, with data being gathered to support this.

How does Lexaria plan to proceed after the HYPER-H21-3 study?

Lexaria plans to submit results from this study to the FDA as part of its investigational new drug research program.