Lexaria Bioscience (OTC: LXRP; CSE: LXX) is responding well to the announcement that it has received ethics board approval from a European university research hospital to conduct an exploratory clinical study using cannabidiol (“CBD”) formulated together with its patented DehydraTECH™ technology. The study will assess blood pressure reduction potential in volunteers with pre-or mild hypertension.
According to Lexaria, the study will be a double-blinded, placebo-controlled, cross-over pilot study where 24 volunteers (12 males and 12 females, aged 45-70 years) will be randomized to receive a 300 mg dose of CBD with or without DehydraTECH™ formulation enhancement. Dosing will be in oral capsule form across two separate study visits. The primary outcome will be automated measures of blood pressure and heart rate. Secondary outcome measures will include circulating plasma concentrations of CBD and assessment of key inflammatory markers associated with cardiovascular disease.
Study Hopes to Improve Upon Data in 2018 Peer-Reviewed Publication
Lexaria noted in its release that this CBD study is intended to complement its previous clinical study from 2018, as published in the peer-reviewed medical journal “Advances in Therapy.” In that study, a single 90mg CBD dose of Lexaria’s TurboCBD™ oral capsule provided evidence of lower blood pressure, higher blood flow to the brain, faster delivery onset of CBD into the bloodstream, and larger quantities of CBD within the blood compared to a single 90mg dose of generic CBD in healthy, normotensive volunteers.
Further, the blood pressure findings from the 2018 study demonstrated a significant 5% reduction in mean arterial blood pressure (MAP) when normalized to end-tidal CO2 at peak blood levels of CBD with Lexaria’s TurboCBD™ compared to placebo (95% CI; p=0.016). Lexaria plans to use higher dosing compared to its 2018 study with hopes to demonstrate that these prior findings will be preserved and improved upon. The trial will evaluate performance in a pre- and mildly hypertensive population more representative of consumers who may benefit from blood pressure control and reduction.
Lexaria expects to have results from the study during the fourth quarter of 2020, with updates provided as the data is analyzed and available.
CBD Study News Follows July Phase I R&D Program Milestone
The news of the CBD study follows the previously announced milestone 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. That Phase I research and development program was initiated to evaluate reduced health risks of a preliminary DehydraTECH™ oral nicotine formulation relative to combusted tobacco.
Study data released by Lexaria in July highlighted the potential benefits from DehydraTECH™ produced products. Those results showed 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 also 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 formulation 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 completed, Lexaria noted that Altria has expressed interest in preserving its right to activate the “First Warrant Tranche Trigger,” a term defined in the Warrant and Option Agreement dated as of January 15, 2019. Terms provide Altria with 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 amount would enable Altria to retain its current exclusivity in the US market for Lexaria’s DehydraTECH™ for oral nicotine delivery purposes.
If Altria does not exercise the First Warrant Tranche, it still maintains its existing minority equity stake and board representation in Lexaria Nicotine LLC. Altria will further retain a non-exclusive license to use DehydraTECH™ worldwide and stay obligated to an earlier-defined royalty payment schedule to Lexaria in the event it decides to utilize it commercially.
DehydraTECH™ Delivers Mass Opportunities
With one Phase I study complete and a new CBD study expected to commence, Lexaria is hoping to leverage what is known about the DehydraTECH™ platform – it improves the way active pharmaceutical ingredients (APIs) enter the bloodstream. The platform also promotes healthier ingestion methods and increases 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.
Most notable, 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 molecules tested or currently under investigation using Lexaria’s DehydraTECH™ include anti-viral drugs, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine, and other molecules.
Lexaria has licensed DehydraTECH™ to multiple companies. Licensees include Altria, to develop smokeless, oral-based nicotine products, and various companies 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 expanding market opportunities and simultaneously evaluating markets that could benefit most from their DehydraTECH™ platform. It’s been noted, too, that the rapid and effective absorption offered by DehydraTECH™ could potentially help the best anti-viral drug candidates in treating COVID-19, which Lexaria has commenced a program to investigate.
Moving into the back half of 2020, Lexaria is also leveraging established relationships with multiple pharmaceutical, nicotine, and cannabis/CBD companies to create more effective treatments and revenue-generating opportunities. The company has stated in company releases that they are in discussions with large tobacco companies and may secure additional partnerships by the end of this year.
The next milestone may come from an uplist to a major US exchange. That process is underway and can generate a new level of interest and exposure to investors. Beyond the value from an uplisting, Lexaria can create shareholder value from a near-infinite set of potential product applications. Those possibilities can set the remainder of 2020 up for substantial growth in both existing and new markets.
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