Biotron Limited (ASX: BIT), a company focused on researching, developing, and commercialising drugs targeting significant viral diseases with unmet medical needs, has announced the successful completion of the first stage of its animal study for Hepatitis B Virus (HBV). The initial phase, a safety study, aimed to determine the appropriate dosage of Biotron’s lead HBV drug for subsequent efficacy testing. The company is developing BIT225 in clinical development for HIV-1 and COVID-19, and has additional promising preclinical programs including HBV.
The study, conducted at the SCRIPPS Research Institute in La Jolla, CA, involved administering three different doses of the drug to mice over seven days. Results indicated that all mice remained healthy throughout the study, with no observable organ toxicity during autopsy. This confirms the safety of the drug at the tested dosage levels, paving the way for the next phase, which will assess the drug’s antiviral activity in two mouse HBV models.
Biotron’s HBV drug will now be evaluated for its ability to protect against and treat HBV infection in these mouse models. One model will provide data on the drug’s impact on early-stage HBV infection, while the other will focus on later stages. Chronic HBV infection can lead to severe complications like cirrhosis and liver cancer, causing nearly one million deaths annually worldwide. Biotron is also continuing its commercialisation activities in collaboration with the US-based C14 Consulting Group.
The company remains engaged in discussions with potential partners following the recent Biotechnology Industry Organisation annual meeting (BIO2025) in Boston, MA, USA, focusing on its HIV-1 program.