(TheNewswire)
Demonstrates Improved Delivery of Two Classes of Drugs in Use Against HIV/AIDS and under investigation Against SARS-CoV-2/COVID-19
Kelowna, British Columbia - TheNewswire - December 1, 2020 - Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announces that its DehydraTECH TM technology significantly improved delivery in study animals of representative drugs from two classes of antiviral therapies (a Protease Inhibitor and a Reverse Transcriptase Inhibitor) under investigation against SARS-CoV-2/COVID-19 and already in use against HIV/AIDS. These are the first two of a series of antiviral drugs to be tested using Lexaria's DehydraTECH technology.
| Drug | Drug Class | AUClast* Delivery & Improvement (hr?ng/mL) | Control (hr?ng/mL) | AUC ?** Delivery & Improvement (hr?ng/mL) | Control (hr?ng/mL) |
| Darunavir | Protease Inhibitor | 721 +- 332 54% (p=0.036) | 469 +- 252 | 726 +- 211 35% (p=0.062) | 536 +- 223 |
| Efavirenz | Non-nucleoside Reverse Transcriptase Inhibitor | 752 +- 203 16% (p=0.11) | 650 +- 148 | 1072 +-40 42% (p=0.028) | 757 +-103 |
Improved Delivery of Both Protease Inhibitor and Reverse Transcriptase Inhibitor Drugs Exhibited Improved Bioavailability Rate as High as 54%
"We are very pleased to have demonstrated improvements in DehydraTECH's delivery of antiviral drugs in animal bloodstream in our very first attempt to do so," said Chris Bunka, Chief Executive Officer of Lexaria. "DehydraTECH is a powerful technology that has now been shown effective through animal testing with antiviral drugs, nicotine, and cannabinoids, demonstrating its versatility to enhance delivery of lipophilic drugs to the bloodstream."
All animals demonstrated excellent safety and tolerability upon dosing with the DehydraTECH formulations, displaying normal activity and behaviour throughout the study with no adverse effects. Lexaria plans to conduct expanded investigations into antiviral drug delivery enhancement and effectiveness beginning in January 2021. These plans include additional antiviral drugs that have already demonstrated usefulness in the fight against HIV/AIDS and are being investigated for use against COVID-19.
This pilot study included DehydraTECH-formulated drugs administered via oral gavage to male Sprague-Dawley rats compared to concentration-matched controls of the same drugs without DehydraTECH formulation. The study was conducted in a total of 40 rats, broken down into four groups of 10 rats per test article. The drugs evaluated were a protease inhibitor (darunavir), and a non-nucleoside reverse transcriptase inhibitor (efavirenz); each administered to the rats in a single dose of 10 mg/Kg in either the DehydraTECH formulation or the control formulation under fed study conditions. The study evaluated total drug delivery into the rodent bloodstream (i.e., Area Under the Curve or "AUC"), whereby the rats were evaluated over a period of 24 hours post dosing to derive the measured AUC over the period (i.e., "AUClast"*), as well as the extrapolated theoretical maximum AUC expected to be achieved thereafter (i.e., "AUC ?"**) .
The study's positive outcomes may have relevance both for the original antiviral therapeutic indications of the drugs that were studied as well as for additional antiviral drugs within their classes for indications including COVID-19. Drugs like darunavir and efavirenz are mainly used for treatment of HIV/AIDS, although their bioavailability alone in oral form is low at 37% and 45%, respectively. If confirmed through additional expanded testing, DehydraTECH could, in theory, improve this bioavailability rate to as high as 64% (i.e., darunavir 37% x 154% = 57%; or efavirenz 45% x 142% = 64%) which could greatly enhance outcomes thus warranting continued investigation.
Furthermore, other types of reverse transcriptase inhibitors like the nucleotide variant remdesivir have already been approved in some jurisdictions for treatment of patients with COVID-19, albeit presently limited to injectable administration due to poor oral bioavailability. Researchers worldwide are also actively evaluating various protease inhibitors that specifically target the main protease associated with SARS-CoV-2 infection in pursuit of additional COVID-19 therapeutic options. If DehydraTECH demonstrates effectiveness in enhancing oral deliverability for compounds in these subclassifications of protease and reverse transcriptase inhibitors, it may hold promise for COVID-19 applicability as well, also warranting further investigation.
About Darunavir
Darunavir is an antiretroviral medication that was approved by the FDA for use in the US in 2008 and in the EU in 2007 and is on the World Health Organization's ("WHO") list of essential medicines. It is primarily used to treat HIV/AIDS and is commonly used with cobicistat or ritonavir and is usually dosed by pill or capsule. Darunavir is a nonpeptidic inhibitor of protease (PR) effected through a number of hydrogen bonds. Protease Inhibitors include many subgroups of molecules that inhibit the breakdown of protein enzymes (proteases).
About Efavirenz
Efavirenz is also an antiretroviral medication approved for use in the US and the EU in 1998 and 1999, respectively, and is now available in generic format. It is also on the WHO list of essential medicines and is most commonly used to treat/prevent HIV/AIDS. Efavirenz is a non-nucleoside reverse transcriptase inhibitor that inhibits activity of reverse transcriptase, which is otherwise required for viruses such as HIV to replicate.
Chris Bunka, CEO, is responsible for the accuracy of this news. The Company is not making any express or implied claims that its products have the ability to eliminate, cure or contain the Covid-19 pandemic (or SARS-CoV-2 or novel Coronavirus) or any other virally induced diseases at this time.
About Lexaria
Lexaria Bioscience Corp.'s (OTCQX: LXRP, CSE: LXX) proprietary drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The Company's technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. DehydraTECH has repeatedly demonstrated since 2016 with cannabinoids and nicotine the ability to increase bio-absorption by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is planned to be further evaluated for orally administered bioactive molecules, including anti-virals, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensed DehydraTECH to multiple companies including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 18 patents granted and approximately 60 patents pending worldwide. For more information, please visit www.lexariabioscience.com .
INVESTOR CONTACT:
ir@lexariabioscience.com
Phone: 866-221-3341