Lexaria's Newest DehydraTECH(TM) 2.0 Formulation Tested in Study HYPER-A21-2 Demonstrates Its Strongest CBD Absorption Results Ever

 

Source: Lexaria Bioscience Corp. 5/20/2021

• New formulation delivers up to 2,708% more CBD into bloodstream*
• Human clinical hypertension study HYPER-H21-1 also progressing

Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (CSE:LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce successful test results of two new "DehydraTECH^™ 2.0" cannabidiol ("CBD") formulations in its second 2021 applied research and development study program, HYPER-A21-2.

"One of our latest DehydraTECH 2.0 formulations gave us the strongest absorption enhancement results we've ever recorded, at 2,708% more CBD into bloodstream during the study period than the representative industry standard MCT control formulation. It was also 174% more effective than the original DehydraTECH 2.0 formulation from 2019," said Chris Bunka, CEO of Lexaria. "This is a 27-fold improvement in CBD delivery compared to the control formulation."

Study HYPER-A21-2 included three additional new DehydraTECH 2.0 formulation variations designed to enhance CBD delivery performance and pharmacokinetic optimization. Two of the three new DehydraTECH 2.0 formulations delivered improved performance when compared to both Lexaria's original DehdyraTECH 1.0 and 2019 DehydraTECH 2.0 concentration-matched formulations, as well as to a medium chain triglyceride ("MCT") oil based control formulation representative of standard industry practices. The final formulation provided useful data but did not deliver enhanced performance compared to the original DehydraTECH 2.0. Summary data is shown below:

Formulation	AUClast (1) (hr∙kg∙ng /mL/mg)	% Improvement over MCT Formulation (p value)	% Improvement over original DehydraTECH 1.0 (p value)	% Improvement over original DehydraTECH 2.0 (p value)
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% (p=0.00009)	108% (p=0.0036)	--
**NEW** DehydraTECH 2.0 Formulation 5 (4)	187 ± 95	1,322% (p=0.0001)	190% (p=0.001)	39% (p=0.08)
**NEW** DehydraTECH 2.0 Formulation 6 (4)	370 ± 172	2,708% (p=0.00005)	472% (p=0.0001)	174% (p=0.0008)

1. AUC: Area Under the Curve, or total CBD delivery into the rodent bloodstream
2. 60-minute study duration
3. 60-minute study duration evaluated in 2019
4. 120-minute study duration evaluated in 2021

Lexaria continues to build a robust body of evidence demonstrating that its patented DehydraTECH technology can significantly enhance the delivery of lipophilic active ingredients such as CBD across a range of uptake levels, with ultimate applications to wide ranging areas including consumer packaged goods as well as drugs with potential for disease treatment applications.

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 taken to assess delivery into the bloodstream and tissues comparing the DehydraTECH formulations to certain controls. There were a total of 120 animals for the new DehydraTECH 2.0 formulations evaluated in studies HYPER-A21-1 and HYPER-A21-2. Both studies HYPER-A21-1 and HYPER-A21-2 were conducted by an independent, premier animal testing laboratory located in the United States.

Lexaria also confirms that its HYPER-H21-1 human clinical hypertension study is currently underway and dosing is nearly complete, utilizing a formulation most closely resembling the original 2019 DehydraTECH 2.0. Along with a more than a 3-fold increase in dose quantity, these formulation improvements are expected to be more effective than the original DehydraTECH 1.0 formulation used in Lexaria's foundational 2018 human clinical study that nonetheless evidenced significant blood pressure reduction, as published and available at PubMed. Lexaria thus expects improved pharmacokinetic performance in its current human clinical study to translate into further improved pharmacodynamic performance. Lexaria will provide details on the outcomes of study HYPER-H21-1 when they become available.

* 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 19 patents granted and approximately 60 patents pending worldwide. For more information, please visit www.lexariabioscience.com.