Biotron Completes Safety Study, Moves HBV Drug to Efficacy Testing

Biotron Limited has completed the initial safety phase of its lead Hepatitis B drug in animal studies, paving the way for efficacy testing in two distinct mouse models. This milestone marks a significant step forward in the company’s antiviral drug development program.

  • First stage animal safety study for HBV drug completed successfully
  • No toxicity observed at various dosages in mice
  • Next phase to test antiviral efficacy in two HBV mouse models
  • Research conducted at SCRIPPS Research Institute, USA
  • Ongoing commercialisation efforts and recent fundraising support progress
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Biotron’s HBV Drug Program Reaches Key Milestone

Biotron Limited (ASX – BIT) has announced the successful completion of the first stage of its animal study for its lead drug targeting Hepatitis B Virus (HBV). This initial phase focused on determining the safety and appropriate dosage of the drug in mice, with no adverse effects or organ toxicity observed. The positive safety profile now clears the way for the next critical phase – assessing the drug’s antiviral efficacy.

From Safety to Efficacy – The Next Step

The upcoming stage involves testing the drug’s ability to protect against and treat HBV infection in two well-established mouse models commonly used for liver disease research. One model will evaluate the drug’s effect on early-stage infection, while the other will focus on later stages. These studies are being conducted at the renowned SCRIPPS Research Institute in California, a hub for cutting-edge biomedical research.

Strategic Progress Amidst a Global Health Challenge

Chronic HBV infection affects over 250 million people worldwide and is a leading cause of liver cirrhosis and cancer. Current treatments can suppress the virus but do not eradicate it, highlighting the urgent need for novel therapies. Biotron’s approach targets key viral mechanisms, including covalently closed circular DNA (cccDNA), a persistent form of the virus that has eluded effective treatment until now.

The company’s recent fundraising efforts have bolstered its capacity to advance this promising program, alongside ongoing commercialisation activities and collaborations, such as with the US-based C14 Consulting Group. Biotron also showcased its broader antiviral portfolio at the BIO2025 conference in Boston, underscoring its commitment to addressing significant unmet medical needs.

Looking Ahead

While the safety results are encouraging, the true test lies ahead in demonstrating the drug’s antiviral efficacy in animal models. Success here could position Biotron as a key player in the fight against HBV, potentially leading to clinical trials and, eventually, new treatment options for millions globally.

Bottom Line?

Biotron’s HBV drug program is advancing steadily, with efficacy results eagerly awaited to validate its therapeutic potential.

Questions in the middle?

  • When will Biotron release results from the efficacy testing phase?
  • What are the timelines and plans for progressing to human clinical trials?
  • How might recent fundraising impact the speed and scale of development?