- Lexaria, a global innovator in drug delivery platforms, has developed the patented DehydraTECH(TM) platform technology, which has been shown to increase the bio-absorption of various fat-soluble active molecules and drugs
- In a recently completed study, Lexaria showed that DehydraTECH-processed CBD had exceptional safety and tolerability profile in addition to resulting in a statistically significant lowering of 24-hour ambulatory blood pressure
- The company also reported that it had demonstrated superior CBD blood absorption levels in its HYPER-H21-4 study from DehydraTECH-CBD relative to those of published comparators
- At the lowest (3.38 mg/kg) and highest (4.46 mg/kg) dose levels tested, DehydraTECH-CBD resulted in 45.8% and 133.4% higher average blood plasma levels, respectively, than the figure reported when a higher (5 mg/kg) dose level of non-Lexaria, pharmaceutical-grade CBD was administered
Global innovator Lexaria Bioscience (NASDAQ: LEXX) has developed a proprietary platform technology that is capable of delivering certain drug molecules more effectively into the human body than their generic forms. That, CEO Chris Bunka contends (https://nnw.fm/iP2FT), allows for various efficiencies and decreases in adverse side effects.
Known as DehydraTECH(TM), the patented technology can be easily incorporated into the formulation and manufacturing processes of existing or new orally ingestible and topical products, according to the company, provided the products are fat soluble. So far, Lexaria has been able to process various active molecules and drugs, including antiviral drugs, nicotine, cannabidiol (“CBD”), vitamins, phosphodiesterase inhibitors, and more, using its DehydraTECH platform technology (https://nnw.fm/Hz3jE). Moreover, the company has, as of December 29, 2022, received a total of 28 patents granted worldwide (https://nnw.fm/xn8YK) for several DehydraTECH-processed applications.
But what is even more remarkable is the fact that Lexaria has evidenced, through multiple animal and human studies, that its DehydraTECH platform technology increases bio-absorption by up to 10x, reduces the time of onset from as much as 1-2 hours to just minutes, delivers drugs more effectively into the bloodstream, and masks unwanted tastes. And in what adds to the company’s repository of the proven benefits of DehydraTECH, the company recently completed a randomized, double-blinded, placebo-controlled cross-over study of 66 male and female volunteers, its most comprehensive hypertension study yet.
Dubbed HYPER-H21-4, the study showed that DehydraTECH-processed CBD had an exceptional safety and tolerability profile. It also evidenced that the formulation resulted in a statistically significant lowering of 24-hour ambulatory blood pressure (“BP”), with the BP lowered for the entire five-week study duration. Furthermore, the BP lowered both for patients not taking any other antihypertensive drugs as well as those currently on antihypertensive medication (https://nnw.fm/xfWSf).
At the time of announcing the results from this study, the company on October 27 stated that “additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon in due course….” And in a December 21 news release, Lexaria reported on one of these findings.
According to this recent announcement, Lexaria reported that it had demonstrated superior CBD blood absorption levels from its patented DehydraTECH-CBD compared to those of published comparators. In their analysis, Lexaria’s researchers compared the average blood plasma levels of DehydraTECH-CBD at various dose levels (after the steady state or the amount of time needed before a consistent dose of drug achieves a stable plasma level had been reached) with that of non-Lexaria, pharmaceutical-grade CBD formulations published in two studies – a 2017 clinical trial and a 2019 study (https://nnw.fm/4jNRf).
The 2017 trial evidenced an average blood plasma CBD level of 23.0 ng/ml after 22 days (the steady state) of daily dosing at a 5 mg/kg non-Lexaria CBD dose level. Lexaria’s HYPER-H21-4 study, on the other hand, showed that the DehydraTECH technology resulted in a 45.8% higher average blood plasma level (33.3 ng/mL) at DehydraTECH-CBD’s lowest dose level tested of just 3.38 mg/kg. When the dose level was increased to 4.46 mg/kg (the highest in the test), the blood plasma level was 133.4% higher than in the 2017 study at 53.7 ng/mL.
On their part, the researchers in the 2017 study evaluated higher CBD dosing at a level of 10 mg/kg, showing a blood plasma level of 62.1 ng/mL. Lexaria’s HYPER-H21-4 study, however, did not see the need to administer a dose as high as 10 mg/kg, with the researchers instead extrapolating the administered dose levels linearly to 10 mg/kg. According to the resulting data trend, a 10 mg/kg dose of DehydraTECH-CBD would result in a plasma level of 149.5 ng/mL, a 141% improvement over the findings contained in the 2017 study.
Using the extrapolated data trend, Lexaria also showed that at a dose level of 10 mg/kg, the absorption resulting from the administration of DehydraTECH-CBD would outperform that of the pharmaceutical-grade, synthetic CBD formulation used in the 2019 study. The non-Lexaria synthetic CBD, the 2019 study showed, reached a blood plasma level of 91 ng/mL. By comparison, Lexaria’s linear extrapolation showed that DehydraTECH-CBD absorption would outperform this figure by 64%.
“DehydraTECH-CBD has repeatedly shown that it can be administered at much lower dose levels than other CBD formulations to achieve effective levels within the bloodstream, as supported by this pharmaceutical-industry peer comparison,” commented Bunka. “This is extremely important to patients hoping to achieve positive health outcomes while using lower levels of medication with no serious side effects and also important to Lexaria as we pursue FDA registration of DehydraTECH-CBD.”
Lexaria hopes to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) this year in anticipation of possible approval to proceed with registered clinical trials evaluating the safety, tolerability, and effectiveness of DehydraTECH-CBD in treating hypertension.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX
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