Biotron Limited’s (ASX: BIT) Phase 2 COVID-19 trial with its lead antiviral drug BIT225 has extended to include a second trial site in Thailand, following receipt of approval from the Khon Kaen University Ethics Committee for Human Research.
Biotron has commenced a Phase 2, double blind, placebo-controlled clinical trial (BIT225-012) to determine if 7 days of treatment with BIT225 commenced within 3 days of onset of COVID- 19 symptoms results in reduction in SARS-CoV-2 blood viral load, clinically favourable changes in viral, inflammatory and immune activation markers, as well as improvement in clinical symptoms of COVID-19.
Much effort and thoughtful consideration has been put into the design and implementation of this important Phase 2 COVID-19 trial,” Managing Director, Dr Michelle Miller said.
“There remains a need for new, effective oral drugs to treat infection and prevent severe disease.
“BIT225 has an established safety profile in human trials, and animal studies have shown it to have both antiviral and immune modulatory activity against SARS-CoV-2. It has the potential to be an important first-in-class drug for COVID-19 treatment. We are now focused on enrolment and dosing with the aim of completing the trial as quickly as possible.”
Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need.
The company has BIT225 in clinical development for HIV-1 and COVID-19, and additional promising preclinical programs including HBV.
In addition, Biotron has several earlier stage programs designing drugs that target a class of virus protein known as viroporins which have a key role in the virus life cycle of a very broad range of viruses, many of which have caused worldwide health issues such as Coronavirus, Dengue, Ebola, Middle East Respiratory virus, Influenza and Zika viruses.
