Last summer, drug delivery platform innovator Lexaria Bioscience (NASDAQ: LEXX) announced a review of its successful 2021 antiviral drug program. The program, which aimed to determine whether the processing of leading antiviral drugs using its patented DehydraTECH could exhibit evidence of superior oral absorption relative to controls; whether DehydraTECH processing of these compounds would preserve the expected viral inhibitory performance; and whether DehydraTECH does not alter or degrade the drug molecules chemically, met all three of these objectives (https://ibn.fm/vgfO7).
Lexaria specifically probed the bioavailability of five DehydraTECH-processed antiviral drugs for SARS-CoV-2, HIV/AIDS, and other infectious diseases from three drug classes, evidencing significant gains with up to a three-fold increase in oral drug delivery into the bloodstream. The demonstrated improvements in absorption, Lexaria believed, could have significant commercial potential considering that many antiviral drugs typically show low oral bioavailability in their available form because of significant liver biotransformation and/or poor intestinal uptake.
Lexaria’s vision for DehydraTECH is not limited to antiviral drugs as the company is also focusing on other possible mainstream applications of its disruptive drug delivery platform, including but not limited to oral nicotine and cannabidiol (“CBD”). Pharmacokinetic studies evaluating these compounds have, in fact, shown that DehydraTECH delivers higher quantities of these APIs in less time. For instance, compared to controls, DehydraTECH-CBD delivered 317% more CBD to the blood a half hour after ingestion, according to a 2018 human study (https://ibn.fm/CXYRe), while DehydraTECH-oral nicotine delivery peaked in bloodstream 10x to 20x faster than controls as seen in an animal study (https://ibn.fm/i6YYL).
DehydraTECH’s ability to increase the performance of different APIs represents multiple commercial opportunities that, when tapped, could potentially address serious unmet patient needs. Of the various markets the company is evaluating, hypertension is a good case in point.
Currently, only 1 in 5 adults with hypertension have it under control (https://ibn.fm/F3wgK), a worrying statistic attributable to the troublesome side effects of medication, which cause the patients to abandon their prescriptions (https://ibn.fm/Yukig). Unfortunately, this means the overwhelming majority are at an increased risk of developing maladies such as heart, brain, and kidney disease or even death – hypertension is a major cause of premature death worldwide. But Lexaria is positioning DehydraTECH-CBD as a potential solution.
Through four human studies, the company has shown that DehydraTECH-CBD is well tolerated by all subjects, with no serious adverse events or side effects reported or observed. Moreover, the first three of these studies represented significant milestones in the pursuit of potential hypertension treatment. They have evidenced a rapid and sustained drop in blood pressure, a 23% average reduction in overnight blood pressure and reduced arterial stiffness, and attenuated pulmonary artery systolic pressure by approximately 5 mmHg, respectively (https://ibn.fm/yd6GR). Lexaria expects to announce the results of its fourth human study, HYPER-H21-4, whose dosing was completed this summer, in due course (https://ibn.fm/O8OJr).
HYPER-H21-4 is designed to enhance the company’s understanding of DehydraTECH-CBD for the treatment of heart disease and other disease states related to increased arterial stiffness. In addition, it is intended to improve Lexaria’s likelihood of success toward an Investigational New Drug (“IND”) application filing seeking the FDA’s approval to begin registered Phase 1b clinical testing. Having held a successful Pre-IND meeting, Lexaria is currently preparing to file the IND application by late 2022 or early 2023 (https://ibn.fm/eXQq1).
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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