Biotron's drug enhances antiviral activity in HIV/HCV infected patients

Friday, October 25, 2013 by Proactive Investors

Biotron's preliminary data from a Phase 2 pilot study of patients co-infected with Hepatitis C and HIV demonstrates that 100% of Genotype 3 patients completing 28 days of treatment with BIT225 in, combination with interferon and ribavirin, had undetectable Hepatitis C levels.

Biotron (ASX:BIT) will trade higher after preliminary data from a study of patients co-infected with Hepatitis C and HIV demonstrates that 100% of Genotype 3 patients completing 28 days of treatment with BIT225 in, combination with interferon and ribavirin, had undetectable Hepatitis C levels.

Patients received interferon (IFN) and ribavirin (RBV) for 7 days prior to receiving 300 mg of BIT225 twice daily plus IFN/RBV for 28 days. After that time, patients continued to take IFN/RBV for a total of 48 weeks.

All patients had undetectable levels of HIV at time of enrolment and continued to take anti-retroviral drugs throughout the study, conducted at Siriraj Hospital in Bangkok.

Interim analysis of virus levels in the treated patients indicates that all six Hepatitic C virus (HCV) Genotype 3 subjects who completed 28 days of BIT225 therapy had undetectable levels of HCV 12 weeks into the study.

Notably, response to treatment at this time point is generally a good indication of final outcome at 48 weeks.

Other new classes of direct-acting antiviral drugs in development have response rates as low as 37% after 12 weeks of treatment. In contrast, the company saw a 100% response at 12 weeks, with only 4 weeks of treatment with BIT225.

The current approved treatment for HIV/HCV co-infected patients is IFN/RBV, however up to 50% of patients are unresponsive.

Biotron’s BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.

A growing data set is underscoring the significance of Biotron’s new generation anti-viral drug portfolio, and BIT225 is also in development for treatment of HIV, with demonstrated clinical efficacy against HIV in reservoir cells.