Benzinga | Jul 21, 2021 07:06AM EDT

Lexaria Highlights VIRAL-A20-3 STudy Results Showing 'Possible Benefits for Treating SARS-CoV-2/COVID-19 and mRNA Vaccine Side Effects'



Possible Benefits for Treating SARS-CoV-2/COVID-19 and mRNA Vaccine Side Effects

KELOWNA, BC / ACCESSWIRE / July 21, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its tolerability and pharmacokinetic study VIRAL-A20-3 has been completed with positive results.

This study demonstrated that DehydraTECHTM enabled colchicine, the latest of several drugs Lexaria has successfully tested with known SARS-CoV-2 antiviral properties, benefited from our proprietary formulation and processing, resulting in increased delivery:

Cmax* % Control AUClast** % ControlDrug Improvement (ng/mL) Improvement (hr?ng/ (ng/mL) (hr?ng/mL) mL)

31.97 104.43Colchicine 91% 16.73 167% 38.97 (p=0.0005) (p=0.0028)

Colchicine is an approved therapeutic with anti-inflammatory effects that is principally used to treat gout and conditions such as cardiac inflammation (i.e., pericarditis), and also has potent effects in mitigating the cytokine storm associated with SARS-CoV-2/COVID-19. Colchicine is occasionally recommended and used to treat emergent pericarditis in children in cases where this form of cardiac inflammation develops following administration of mRNA COVID-19 vaccines.

Similar to other antiviral agents that Lexaria has processed with DehydraTECH (e.g., darunavir, efavirenz, remdesivir's nucleoside analogue GS-441524 and ebastine), oral colchicine in its available forms today exhibits diminished bioavailability in humans, which Lexaria believes it can improve upon for better safety and efficacy outcomes. Currently available oral colchicine demonstrates bioavailability of about 45%.

Colchicine is also known to have a narrow therapeutic index, meaning the distinction between toxic and non-toxic doses is marginal and there could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels. Lexaria hopes to improve the bioavailability of colchicine to a sufficient level which could potentially allow for lower overall dosing requirements.

Study VIRAL-A20-3 was performed using Sprague-Dawley rats, with twenty rats dosed via oral gavage using either DehydraTECH or control colchicine formulations (i.e,. 10 rats per test article). The study evaluated peak concentration ("Maximum Concentration" or "Cmax"*) and total drug delivery into the rodent bloodstream ("Area Under the Curve" or "AUClast**"). The study was conducted by an independent, premier animal testing laboratory located in the United States.

The study also examined absorption with two other antiviral drugs previously untested by Lexaria. The bloodstream delivery findings were unremarkable with these two drugs, which Lexaria believes was correlated to analytical methodology limitations related to discerning blood levels for the two drugs in question. Further work would be required should Lexaria decide to pursue additional testing with these two drugs, however, Lexaria will likely focus on DehydraTECH-processed colchicine and other antiviral drugs it has tested given the superior results already demonstrated.

Lexaria will summarize and provide guidance on the 2021 antiviral program to date and next steps it is planning in an imminent press release. Chris Bunka, CEO, is responsible for the accuracy of this press release. 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.