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Lexaria Bioscience Reaches New Milestone After Completing Phase 1 Study With Altria For Oral Nicotine Delivery

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Lexaria Bioscience Reaches New Milestone After Completing Phase 1 Study With Altria For Oral Nicotine Delivery

July 20
10:26 2020

Lexaria Bioscience Corp (OTC: LXRP) has reached a new milestone after announcing that Phase I of the research and development program of oral forms of nicotine delivery utilizing Lexaria’s patented DehydraTECH™ technology with Altria Ventures Inc. (NYSE: MO) has concluded.

Lexaria Bioscience Corp. is a global innovator in drug delivery platforms. Its DehydraTECH™ platform is its unique, next-generation technology that can potentially revolutionize drug delivery technology. Beyond nicotine, its use extends seamlessly through multiple areas of the pharmaceutical sector by taking existing orally-administered therapies and improving the way they are detected and absorbed by the body. 

Specific to the study with Altria, the Phase I research and development program was initiated to evaluate reduced health risks of a preliminary DehydraTECH™ oral nicotine formulation relative to combusted tobacco. Lexaria provided earlier findings from the study in 2019. On Thursday, additional data were determined and published about the ge DehydraTECH™ formulation.

New Findings From Altria-Lexaria Study

Relevant new data released by Lexaria demonstrates the potential power in DehydraTECH™ produced products. The results show that the DehydraTECH™ formulation demonstrated acceptable chemical and microbiological stability, and was well-tolerated in a 7-day, repeat dose acute toxicology study in rats. Those results showed no test article-related effects on survival, macroscopic findings, or organ weights. There were also no test article-related histopathological tissue findings.

Further, the formulation created no issues with throat burn or irritation in an oral pouch or chew formats at standard commercial doses upon small scale sensory analysis in humans. Data demonstrated the formation of a unique mixture of nanoparticles without creating a covalently linked, new molecular entity construct upon molecular characterization by Canada’s National Research Council (NRC). Thus, the product is not believed to be preclusive of Premarket Tobacco Product Application (“PMTA”) applicability in this respect.

With Phase I of the research and development program closed, Altria has expressed interest in exercising its right to activate the “First Warrant Tranche Trigger,” a term defined in the Warrant and Option Agreement dated as of January 15, 2019. Altria now has 90 days, or until 11:59 pm on October 8, 2020, to exercise its First Warrant Tranche by way of a further staged payment to Lexaria Nicotine as per the agreements among the parties. The payment would enable Altria to retain its current exclusivity in the US market for Lexaria’s DehydraTECH™ for purposes of oral nicotine delivery.

Regardless of whether Altria exercises the First Warrant Tranche, Altria maintains its existing minority equity stake and board representation in Lexaria Nicotine LLC. Altria also retains a non-exclusive license to use DehydraTECH™ worldwide outside of the US and has agreed to an earlier-defined royalty payment schedule to Lexaria in the event it decides to utilize it commercially.

Video Link: https://www.youtube.com/embed/-N1krKKbWGs

Valuable Insights From Completed Study

The findings from this Phase I research and development program offers many valuable insights about the DehydraTECH™ technology. It also positions Lexaria to continue showcasing its advanced technology to other tobacco, nicotine, and pharmaceutical companies. Lexaria noted that they are currently in discussions with two other companies that are each one of the world’s ten largest tobacco firms. The company believes the suitability of DehydraTECH™ to successfully deliver nicotine through oral methods has been enhanced due to the extensive scientific rigor it was subjected to during the 2019 R & D program. It is highly positive regarding its commercial future.

The Power Of DehydraTECH™

Already known is that DehydraTECH™ improves the way active pharmaceutical ingredients (APIs) enter the bloodstream. The results promote healthier ingestion methods and increase the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules.

Importantly, DehydraTECH™ increases bio-absorption by up to 5-10x, reduces the time of onset from 1 – 2 hours to 10 – 20 minutes, and masks unwanted tastes for orally administered bioactive molecules. Examples of those include anti-viral drugs, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine, and other molecules.

Lexaria has licensed DehydraTECH™ to multiple companies, including Altria, for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. The company operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 16 patents granted and over 60 patents pending worldwide.

Moving Fast To Exploit Market Opportunities

Lexaria Bioscience is evaluating markets that could benefit most from their DehydraTECH™ platform. There is potential, too, that the rapid and effective absorption offered by DehydraTECH™ could substantially help the best anti viral drug candidates in treating COVID-19.

Lexaria is also leveraging established relationships with multiple pharmaceutical, nicotine, and cannabis/CBD companies to create more effective treatments and revenue-generating opportunities in 2020. As noted above, the company is in discussions with large tobacco companies and may secure additional partnerships by the end of this year.

Also notable, the company has announced that a major US exchange uplist program is underway, which can generate a new level of interest and exposure to investors. With licensees already on the books, combined with the potential of near-term monetization of non-core assets, Lexaria Bioscience may be well-positioned to increase shareholder value in the coming months.

With a near-infinite set of potential applications, Lexaria may be on the verge of realizing tremendous growth. The technology is not only considered next-generation, but their side-by-side work with industry leaders can improve the standard of care for patients in a broad range of indications.

 

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