Lexaria Bioscience Corp (LEXX)

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https://www.accesswire.com/644927/Lexaria-Issues-Successful-Results-from-First-2021-Study-HYPER-A21-1
Lexaria Issues Successful Results from First 2021 Study, HYPER-A21-1
(via TheNewswire)

• - Up to 2,178% more CBD delivered into bloodstream*
- Up to 1,737% more CBD delivered into brain tissue*
Kelowna, British Columbia – TheNewswire - May 6, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (CSE:LXX) (CNSX:LXX.CN) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to announce successful outcomes in its first sets of data from its 2021 applied research and devel opment (R&D) study programs.
Study HYPER-A21-1 included three new “DehydraTECH 2.0” formulation variations designed to enable cannabidiol (“CBD”) delivery performance enhancements and pharmacokinetic optimization. All three new DehydraTECH 2.0 formulations delivered improved performance when compared to both Lexaria’s original DehydraTECH 1.0 and 2.0 concentration-matched formulations, as well as to a medium chain triglyceride (“MCT”) oil based control formulation representative of standard industry practices Summary data is shown below:

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|Formulation |AUClast (1) |% Improvement over MCT|% Improvement over |% Improvement over |
| | |Formulation |original DehydraTECH 1.0|original DehydraTECH 2.0|
| | (hr·kg·ng |(p value) |(p value) |(p value) |
| |/mL/mg) | | | |
|--------------------------------------------------------------------------------------------------------------------|
|MCT Control(2) |13.17± 6.78 |-- --- --- |
|--------------------------------------------------------------------------------------------------------------------|
|Original(2)DehydraTECH 1.0|64.6± 23.7 |390% | | |
| | |(p=0.00002) |-- --- |
|--------------------------------------------------------------------------------------------------------------------|
|Original(3)DehydraTECH 2.0|134.7± 63.7 |923% |108% |-- |
| | |(p=0.00009) |(p=0.0036) | |
|--------------------------------------------------------------------------------------------------------------------|
|**NEW**DehydraTECH | |1,068% |138% |14% |
|2.0 Formulation |153.9± 62.8 |(p=0.00003) |(p=0.0006) |(p=0.253) |
|1(4) | | | | |
|--------------------------------------------------------------------------------------------------------------------|
|**NEW**DehydraTECH | |1,540% |234% |60% |
|2.0 Formulation |216.0± 94.9 |(p=0.00004) |(p=0.0003) |(p=0.018) |
|2(4) | | | | |
|--------------------------------------------------------------------------------------------------------------------|
|**NEW**DehydraTECH | |2,178% |364% |123% |
|2.0 Formulation |300.1± 126.6 |(p=0.00007) |(p=0.0002) |(p=0.002) |
|3(4) | | | | |
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1. (1)AUC: Area Under the Curve, or total CBD delivery into the rodent bloodstream
2. (2)60-minute study duration
3. (3)60-minute study duration evaluated in 2019
4. (4)120-minute study duration evaluated in 2021
“Not only did the three latest DehydraTECH 2.0 formulations deliver between 1,068% and 2,178% more CBD during the study period than the standard MCT control formulation, they also were up to 123% more effective than the original DehydraTECH 2.0 formulation,” said Chris Bunka, CEO of Lexaria. “Said another way, for every 1 mg of CBD delivered by the industry standard MCT control formulation, these latest DehydraTECH 2.0 formulations delivered 10 to 21 mg of CBD.”
The study demonstrated that each of the new DehydraTECH 2.0 formulations delivered very high levels of CBD absorption into brain tissues, dwarfing the levels achieved with the MCT oil-based control formulation. The three new DehydraTECH 2.0 formulations delivered between 907%-1,737% more CBD into brain tissue than the MCT oil based control formulation, similar to the up to 1,937% increase over the MCT oil based control formulation announced previously for Lexaria's original DehydraTECH 2.0 formulation.
In each arm of the study, ten male Sprague-Dawley rats were dosed orally at a level of 25 mg/Kg CBD, and over the next 120 minutes multiple measurements were made of delivery into the bloodstream and tissues comparing the DehydraTECH formulations to certain controls.
These study findings add significantly to Lexaria’s body of evidence demonstrating the ability of its DehydraTECH technology to be engineered to enhance the delivery of lipophilic active ingredients such as CBD across a range of uptake levels, whereby higher delivery level targets may be most applicable to pharmaceutical dosage forms and lower delivery level targets more suited to consumer packaged goods.
Additional DehydraTECH 2.0 formulations are being evaluated in Lexaria study HYPER-A21-2 presently underway, and results are expected in late May or early June, 2021. Thereafter, Lexaria is planning additional work that will evaluate impacts upon real-time blood pressure in animals using select formulations pursuant to these studies. Lexaria will provide more details on this upcoming blood pressure testing in animals as they become available. As well, advanced DehydraTECH 2.0 formulations are already being used by Lexaria in ongoing human studies and will be monetized for commercial use when applicable.
* Compared with control formula utilizing medium chain triglycerides (coconut oil)representative of standard industry practices
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s proprietary drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The Company’s technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. DehydraTECH has repeatedly demonstrated since 2016 with cannabinoids and nicotine the ability to increase bio-absorption by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is planned to be further evaluated for orally administered bioactive molecules, including anti-virals, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensed DehydraTECH to multiple companies including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 18 patents granted and approximately 60 patents pending worldwide. For more information, please visit www.lexariabioscience.com.