- Biotron (BIT) enters phase II of its COVID-19 clinical trial using its lead antiviral drug, BIT225, to test 60 male and female patients between 18-59 years old
- The trial will determine if BIT225 reduces the SARS-CoV-2 virus load in the blood through oral administration
- The trial will evaluate the drug’s antiviral activity, safety, and immune biomarkers in non-hospitalised, vaccinated and unvaccinated adults suffering from COVID-19
- The first trial site has been approved in Bangkok, Thailand, while several other sites across the country await Institutional Review Board (IRB) approval
- BIT shares are up 3.45 per cent and trading at three cents at midday AEST
Biotron (BIT) has kicked off a phase II trial of its lead antiviral drug, BIT225, to treat COVID-19 within three days of the onset of symptoms over seven days of treatment.
The trial aims to determine whether BIT225 can reduce the viral load of SARS-CoV-2 in the blood through the oral administration of a SARS-CoV-2 viroporin inhibitor.
The antiviral drug will evaluate antiviral activity, safety, and immune biomarkers in non-hospitalised, vaccinated and unvaccinated adults suffering from COVID-19.
The primary objectives of the study will be to determine the tolerability of BIT225 when dosed at 200mg or 400mg per day for seven days within three days of the onset of symptoms. Any safety concerns will be assessed by the frequency of adverse events.
The study will be a double-blind, placebo-controlled clinical trial that will recruit 60 adult male and female individuals aged 18 to 59 years, with full recruitment aimed for mid-2023 and data available by the early second half of 2023.
BIT said in addition to its unique clinical benefits against Human Immunodeficiency Virus‐1 (HIV-1), BIT225 had successfully prevented the development of disease in COVID‐19 mouse models.
The design of the trial was based on guidance received in 2022 from the USA Food and
Drug Administration (FDA) and took into consideration the continually-changing landscape of COVID-19.
BIT has consulted with international clinicians, clinical research organisations, and other relevant experts to design a quick-paced study to generate data within a tight timeframe.
The first trial site has been approved in Bangkok, Thailand, while several other sites across the country await Institutional Review Board (IRB) approval.
BIT shares were up 3.45 per cent and trading at three cents at midday AEST.