Biotron's BIT225 effectively cures HCV in pilot trial


By Dylan Bushell-Embling
Friday, 10 October, 2014


Biotron's BIT225 effectively cures HCV in pilot trial

Biotron (ASX:BIT) said its BIT225 drug candidate served as an effective cure for hepatitis C during a phase II trial.

All five HCV genotype 3 patients completing treatment had undetectable levels of the virus 12 weeks after completing all treatment.

The endpoint of HCV treatment is a sustained virologic response, and such a response at week 12 is considered a prediction of permanent clearance of the virus - effectively a cure.

The open-label pilot trial in Bangkok involved eight patients co-infected with HIV and HCV genotype 3. The patients all received standard of care HCV drugs interferon and ribavirin (INF/RVB) for seven days before commencing treatment with the drug.

Patients then received 300 mg of BIT225 twice daily in combination with INF/RVB for 28 days, and then continued to take INF/RBV until week 48.

Of the eight patients, three withdrew during the first 12 weeks due to intolerance of IFN/RVB. The remaining five completed treatment.

“These SVR12 data support the efficacy of BIT225 as a potential new therapy for HCV and, in particular, for this difficult to treat group of HIV/HCV co-infected patients who typically have more serious HCV infection and fewer treatment options,” Biotron Managing Director Dr Michelle Miller said.

Previous trials of BIT225 in HCV have focused on genotype 1, the most common strain in western countries, but genotype 3 is endemic in Southeast Asia.

Biotron is currently involved in a three-month dosing phase II, placebo-controlled, doubled-blinded trial of BIT225 and IFN/RBV in both HCV genotypes 1 and 3. Preliminary results are due by the end of the year.

Biotron (ASX:BIT) shares were trading 65% higher at $0.165 as of around 1.30 pm on Friday.

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