- Lexaria is a global innovator in drug delivery platforms whose lead technology is DehydraTECH(TM)
- Studies have shown that DehydraTECH increases the intestinal bioabsorption of bioactive compounds by as much as 27 times, hence resulting in greater bioavailability; pre-clinical and human studies have demonstrated that DehydraTECH-CBD enables absorption increases of between 100% and 500% The studies have also shown that DehydraTECH-CBD results in a rapid and sustained drop in blood pressure among hypertension patients
- Lexaria, which believes there is a significant unmet demand for cost-effective hypertensive treatments with few or no side effects, is working toward commercializing DehydraTECH-CBD to satisfy this demand
Currently, roughly 20% of people diagnosed with hypertension take medication, with the remaining majority noting that the medications’ side effects substantially outweigh the benefits. This has often constrained the fight against hypertension, the most common cardiovascular disease worldwide, which affects more than one billion people and is associated with long-term morbidities such as heart disease, stroke, and even death.
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, believes the hesitance or refusal to take medication presents a significant unmet demand for more tolerable, cost-effective anti-hypertensive treatments and has been working to bring such treatments to the masses. Specifically, the company is developing a new potential treatment with few or no side effects to address a majority of hypertensive patients’ concerns about taking hypertension medication.
The company’s drug candidate, DehydraTECH(TM)-processed CBD, has been the subject of animal and human studies, which have yielded “extremely promising early results,” according to Prof. Philip Ainslie, PhD., Lead Investigator in Lexaria’s human hypertension studies, who was recently interviewed by PCG Digital (https://ibn.fm/gKxMY). These results are thanks, in part, to the improved performance offered by the company’s patented DehydraTECH drug delivery technology.
The technology, Lexaria’s studies have shown, increases the intestinal bioabsorption of bioactive compounds by as much as 27 times. This results in greater bioavailability of these therapeutics at lower doses. Nowhere else is this as apparent as in the case of CBD. CBD or cannabidiol, Prof. Ainslie explained, “is a complex fat-soluble molecule and is known to have poor absorption characteristics. Typically, only about 6% of what is orally ingested enters the bloodstream. Through our pre-clinical and human studies, we have shown that DehydraTECH technology enables absorption increases of between 100% and 500%.”
Additional results from the company’s 2021 studies – HYPER-H21-1, HYPER-H21-2, and HYPER-H21-3 – have demonstrated that DehydraTECH-CBD caused a rapid and sustained reduction in blood pressure among hypertensive volunteers. “The improvements in blood pressure results were particularly remarkable given the fact that many existing drugs used to treat hypertension require several weeks of treatments and/or combination dosing before they produce comparable reductions in blood pressure,” underlined Prof. Ainslie.
Just recently, Lexaria completed its most comprehensive human hypertension study, HYPER-21-4, which enabled them to gather critical data monitoring the safety and efficacy of the DehydraTECH-CBD formulation over a prolonged period. The study, Prof. Ainslie noted, will allow the company to evaluate the formulation’s potential for longer-term health benefits.
The completed studies are, however, just the beginning – Lexaria plans to undertake clinical trials with the FDA that seek to demonstrate the safety and tolerability profile relative to conventional anti-hypertensive medications. These trials will also aim to avoid serious adverse events at clinically efficacious doses.
According to the Lead Investigator, establishing safety is extremely important because, though often well-tolerated, CBD can potentially cause liver toxicity, particularly when given in the high therapeutic doses required for conditions such as epilepsy or hypertension. As a baseline, Epidiolex, the only FDA-approved CBD drug, has an approved dose of 10mg per kilogram of body weight, given twice daily. Lexaria, however, believes its DehydraTECH technology has the potential to reduce the prescribed doses because of its ability to enhance CBD’s bioavailability.
“There could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels, and we have already been investigating a range of doses lower than those already approved by FDA for Epidiolex, for example,” Prof. Ainslie emphasized.
The completed and planned research is part of a greater goal: commercialization. To that end, Lexaria has engaged the FDA resulting in confirmation that the agency supported the company’s proposal to pursue the abbreviated 505(b)(2) New Drug Application (“NDA”) (https://ibn.fm/tZz5Y). The abbreviated pathway enables a faster route to commercial approval than the traditional pathway.
Presently, and following the confirmation, the company is working on preparatory work that will facilitate the filing of an Investigational New Drug (“IND”) application and is on track to file by year’s end or early 2023. Thereafter, and upon approval of the application, Lexaria expects to commence its proposed US-based Phase 1b clinical trial involving about 100 hypertension patients. As part of the study, the participants will receive a dose of DehydraTECH-CBD to evaluate the safety and efficacy of the formulation as well as 24-hour ambulatory blood pressure.
For more information, visit the company’s website at www.LexariaBioscience.com.
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