Biotron gets ethics nod for HCV trial

Biotron (ASX:BIT) has secured ethics approval for a three-month phase II dosing study of antiviral drug candidate BIT225 in patients with hepatitis C (HCV).

The phase II trial will involve 60 patients at up to six trial sites in Thailand. Patients will be given the new capsule form of BIT225, not the powder formulation used in an earlier HCV trial.

The trial will also evaluate the safety and efficacy of the drug when administered over a three-month period, instead of the four weeks from the prior trial.

Initial dosing is now expected to commence by the end of the month and Biotron expects the trail to be fully recruited by mid-2014.

Patients will be administered BIT225 twice daily for three months in combination with standard-of-care therapies interferon alfa 2b (IFN) and ribavarin (RBV). They will then continue to receive standard of care alone out to 24 weeks for HCV genotype 3 patients or 48 weeks for genotype 1.

During the previous phase IIa study, 100% of patients receiving the highest dose of BIT2225 had undetectable levels of virus in the blood at 48-week follow-up, compared to just 75% of the control group receiving standard of care alone.

Biotron is also developing BIT225 as a prospective HIV treatment and recently commenced a concurrent phase II trial of the drug in patients co-infected with both HIV and HCV.

Biotron (ASX:BIT) shares were trading 1.25% higher at $0.081 as of around 2 pm on Thursday.