Lexaria Announces R&D Program to Compare First and Only FDA-Approved Prescription Cannabidiol
Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) has launched a study (EPIL-A21-1) to assess the effectiveness of its DehydraTECHTM-CBD against the FDA-approved Epidiolex in reducing seizure activity. This animal study involves a leading US lab and is expected to yield results by Q3 2022. In addition, Lexaria has secured its first patent for DehydraTECH in Mexico and a fifth patent in Japan for its use with cannabinoids. Lexaria continues to expand its intellectual property portfolio, with a total of 23 patents granted worldwide.
- Launch of study EPIL-A21-1 to compare DehydraTECH-CBD with Epidiolex for seizure reduction.
- First patent for DehydraTECH awarded in Mexico, expanding IP portfolio.
- Fifth patent awarded in Japan for DehydraTECH's cannabinoid applications.
- Study results are not expected until Q3 2022, leading to a delay in potential market impact.
- New study EPIL-A21-1 will compare effectiveness of FDA-approved Epidiolex to DehydraTECHTM-CBD for reducing seizure activity
KELOWNA, BC / ACCESSWIRE / November 1, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, has commenced an important new study exploring whether DehydraTECHTM-CBD evidences superior ability to inhibit seizure activity compared to both generic cannabidiol ("CBD") and Epidiolex.
Epidiolex is the first and only FDA-approved CBD medication for the treatment of seizures associated with two rare and severe forms of paediatric epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
Experts in respirology and neurobiology are among the talented team assembled to conduct the study which is designed to investigate if DehydraTECH-CBD has similar or superior levels of efficacy in treating seizures as does the world's only CBD-based seizure medication, Epidiolex. Lexaria's seizure program has been developed due to the significant gains in systemic delivery and brain uptake that Lexaria has repeatedly evidenced and announced from other studies comparing DehydraTECH-CBD with concentration-matched controls, which it believes has potential to improve therapeutic efficacy for a range of disease conditions affecting the central nervous system including epilepsy.
Epidiolex was developed by GW Pharmaceuticals plc ("GW") and is now sold by Jazz Pharmaceuticals ("Jazz") subsequent to the 2021 US
Animal study EPIL-A21-1 has entered early-stage preparatory work and results are expected by Q3 2022. This animal study is being conducted by a leading US-based independent laboratory using advanced DehydraTECH 2.0 formulations and is fully funded through existing Lexaria resources.
In other developments, Lexaria is pleased to report its first patent award for DehydraTECH in Mexico. The patent award protects Lexaria's proprietary DehydraTECH for use with cannabinoids and nicotine. The Company has also been awarded another patent in Japan for the use of DehydraTECH utilizing non-psychoactive cannabinoids, nicotine, vitamins, or non-steroidal anti-inflammatory ("NSAID") substances. This latest patent award in Japan becomes Lexaria's 5th patent awarded in 2021. Lexaria's patented DehydraTECH currently benefits from 23 granted patents in the countries of the USA, Australia, the European Union, India, Japan, and Mexico. Lexaria continues to build its intellectual property portfolio in these and other countries.
About Epidiolex
Epidiolex is an FDA-approved prescription CBD available in an oral solution to treat Lennox-Gastaut syndrome and Dravet syndrome in children two years of age and older. Epidiolex's effectiveness was studied in three randomized clinical trials involving a total of 516 patients and was shown to be effective in reducing the frequency of seizures when compared to placebo. In September 2019, Epidiolex was approved for use in all 27 member countries of the European Union.
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 up to 5-10x, 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), 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:
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
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FAQ
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