- Biotech company Biotron (BIT) says a new study of its lead clinical drug, BIT225, has been shown to be effective against established SARS-CoV-2 in mice
- The study showed BIT225 to protect against severe disease in mice that were infected with SARS-CoV-2, the virus that causes COVID-19, up to 48 hours before treatment
- Managing Director Michelle Miller says the results of the study show the “clear benefit” of BIT225 regardless of when treatment was commenced
- Biotron has submitted a proposal to the US Food and Drug Administration to conduct human clinical trials and says it expects a response “shortly”
- Biotron shares are soaring 23.29 per cent to 9 cents per share
Antiviral biotechnology company Biotron (BIT) today said its lead clinical drug, BIT225, had been shown to be effective against established SARS-CoV-2 in mice.
The company said an animal study at the SCRIPPS Research Institute in California showed BIT225 to protect against severe disease in mice that had already been infected with SARS-CoV-2, the virus that causes COVID-19.
In previous studies, animals were dosed with BIT225 12 hours before infection with COVID-19. In this new study, the animals were infected with COVID-19 up to 48 hours before starting their BIT225 treatment.
The study showed that mice starting treatment with BIT225 after infection with SARS-CoV-2 had similar levels of protection against severe disease as mice starting treatment with BIT225 prior to infection.
All BIT225 pre-dosed mice and 24-hour post-dose mice remained healthy and continued
to gain weight as per age expectations through to day 12 when the study was completed. One of the five animals in the 48-hour post-dosing cohort died on day 11 of the study.
Biotron said the new data showed that BIT225 protected from severe diseases even once there was an established infection.
“The results from this new study are important as they show a clear clinical benefit for BIT225 regardless of the time of commencement of treatment,” Managing Director Michelle Miller said.
“We believe that BIT225’s extended therapeutic protection window sets it apart from other approved or in-development agents and further strengthens our confidence in this valuable clinical asset.”
The company said results from this study would provide key information that would help determine the dosing regimen for BIT225 in planned human clinical studies.
In March, the company submitted a proposal to the USA Food and Drug Administration to conduct human clinical trials to assess the efficiency of BIT225 for the treatment of COVID-19. The company said it was expecting a response from the FDA “shortly”.
Biotron shares were soaring 23.29 per cent to 9 cents per share at 12:34 pm AEST.