Biotron (ASX:BIT) has announced that its lead clinical asset, BIT225, has demonstrated substantial and clinically meaningful efficacy against SARS-CoV-2 in a series of animal and cell-based studies performed at The SCRIPPS Research Institute in the US.
BIT225 was tested in a COVID-19 mouse model (K18-hACE2). The company said these mice have been engineered to be infectable by SARS-CoV-2 which then produces a range of pathologies including pulmonary disease. This model is routinely used to assess the ability of drugs to target SARS-CoV-2 and treat COVID-19 disease.
"The study in the COVID mice showed that BIT225 given orally (by mouth) significantly reduced virus load in the lungs of treated mice when compared with control mice that were given drug-free control material (known as vehicle control)," said the company.
"There was also a reduction in virus in the blood. The reduction in virus was dose-dependent - i.e. reduction in viral load was greater at the higher dose. Increased levels of pro-inflammatory cytokines (‘cytokine storm’) are linked to severe illness and death in people infected with SARS-CoV-2 virus. Controlling this cytokine storm is essential for successful treatment of COVID-19."
The company said BIT225 significantly reduced all assayed pro-inflammatory cytokines and chemokines in the lungs and blood of treated mice compared to control mice.
During the course of infection with SARS-CoV-2, K18 mice generally develop severe disease that is reflected in the loss of body weight. The animals treated with BIT225 did not lose weight throughout the study and, significantly increased their weight in line with growth expectations of the age of the animals.
"The data showed that BIT225 reduced the delta virus in the cell cultures by more than 99.99% (over 4 logs reduction). The in vivo study demonstrates that BIT225 is highly effective antiviral agent and protects the animals from severe disease. The in vitro study demonstrates that BIT225 is also active against the highly infectious delta strain of SARS-CoV-2."
BIT225 belongs to a new class of antiviral drugs known as viroporin inhibitors. It targets key viral-encoded proteins known as viroporins that are central to establishing and maintaining infections through modulation of the body’s immune system.
The chair of Biotron’s scientific advisory board, Professor Rob Murphy, Professor of Medicine and Biomedical Engineering, John P. Phair Professor of Infectious Diseases at Northwestern University, Chicago, said, “These very encouraging results in a SARS-CoV-2 animal model demonstrate a robust antiviral response that justifies further study in humans. BIT225 is a novel antiviral drug that has been safely used in over 200 patients with other RNA viral diseases including HIV and hepatitis C. This is drug that should be studied as a COVID19 treatment in the very near future.”
Biotron’s managing director Michelle Miller said, “These results suggest that BIT225 may have benefit over other known antiviral agents. We will actively pursue all avenues to progress this Biotron drug into human trials as quickly as possible.”