- Lexaria expects to begin dosing this summer as part of a human nicotine study, NIC-H22-1, to compare DehydraTECH-nicotine pouch performance to that of existing leading brands such as ON! and Zyn
- So far, the company’s animal studies have evidenced that the technology delivers outstanding results, including faster delivery, an increase in the quantity of peak nicotine delivered, higher brain levels of nicotine, and enhanced bioavailability
- In its most recent study, Lexaria established that DehydraTECH-oral nicotine delivery peaked in bloodstream 10x to 20x faster than controls and peak levels achieved were up to 10x higher than controls
- Lexaria’s research aims to support a safe alternative to the harmful, antiquated pulmonary nicotine administration practices, which claim 7.7 million lives annually
Since commencing in vivo studies evaluating its DehydraTECH technology for oral nicotine applications in 2018, global innovator Lexaria Bioscience (NASDAQ: LEXX) has primarily focused on animal studies that have proven the technology’s effectiveness in promoting faster absorption, higher peak absorption, and greater overall quantities of nicotine, on average, in the blood than concentration-matched control formulations. Building on the successes of these animal studies, Lexaria has now set its sights on a human nicotine study, NIC-H22-1, which is expected to begin dosing this summer (https://ibn.fm/DwaiJ).
NIC-H22-1, a pharmacokinetic randomized, double-blinded, cross-over study involving 36 human participants, will compare Lexaria’s DehydraTECH-nicotine pouch performance to that of existing leading brands available to US consumers, namely ON! and Zyn. The study primarily aims to collect data on the maximum concentration of nicotine in the bloodstream (“Cmax), the time at which Cmax was reached (“Tmax”), and the area under the (“AUC”) – a parameter that indicates the total quantity of nicotine delivered over time – relative to controls. In addition, as part of its secondary objectives, the study NIC-H22-1 will include extensive subjective evaluations related to, among other things, the user experience and throat burn.
Ultimately, Lexaria hopes to evidence that DehydraTECH-processed purified nicotine improves oral tissue absorption and reduces negative experiences compared to brands currently sold to consumers.
Lexaria’s first animal study, whose results the company announced in April 2018, revealed that DehydraTECH delivered significant nicotine absorption performance improvements relative to controls. These included: 1,160% faster delivery of equivalent quantities of nicotine; 148% uptick in the quantity of peak nicotine delivered to the bloodstream; 560% higher brain levels of nicotine; enhanced bioavailability as evidenced by lower urine levels of nicotine; and lower quantities of key liver metabolites in the bloodstream, suggesting bypass of first-pass liver metabolism (https://ibn.fm/uIr7z).
Later in August 2018, Lexaria announced the results of an animal study showing the company had successfully delivered nicotine in an edible form into the blood plasma a few minutes after dosing. Notable highlights from the study included a 79% improvement in Cmax; a 94% enhancement in AUC, a 70% improvement, on average, in the speed of delivering the nicotine; and significantly greater absorption levels. According to Lexaria, this study corroborated and confirmed the validity of the April 2018 results (https://ibn.fm/yefXr).
In 2021, the company announced its oral nicotine absorption study, NIC-A21-1, revealing that DehydraTECH-oral nicotine delivery peaked in bloodstream 10x to 20x faster than controls and peak levels achieved were up to 10x higher than controls (https://ibn.fm/FzMmH).
“Performance gains of this magnitude could be of great significance in enabling the oral pouch product category to offer improved nicotine satiety and effectiveness, with a goal of one day rendering pulmonary administration practices like smoking and vaping as obsolete,” Lexaria CEO Chris Bunka said of last year’s outstanding results.
Through its focus on oral nicotine products as well as its ever-growing portfolio of in vivo studies, Lexaria’s research aims to support a safer, more effective nicotine alternative to 1.1 billion smokers worldwide (as of 2019). With tobacco causing 1 in 5 deaths in males globally and roughly 7.7 million cumulative deaths annually (https://ibn.fm/nlHsM), Lexaria’s DehydraTECH technology, which has so far delivered outstanding results in animals, could help the millions of users move away from the harmful smoking habit. And the upcoming human study is expected to inch the company closer to realizing this goal. In fact, Lexaria is optimistic this larger human study will produce positive findings pursuant to those evidenced by the 2021 study.
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://ibn.fm/LEXX
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