16 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Biotron, a clinical-stage drug development company focused on development of new generation antiviral drugs, will report new clinical data from its phase IIa trial of BIT225 in patients infected with hepatitis C virus (HCV). The data will be detailed in a late-breaking presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 annual conference in Boston, US.
Previously released data from the 28-day phase IIa trial of BIT225 demonstrated that BIT225 significantly increased the response to the current approved anti-HCV treatment, with improved outcomes for those patients infected with HCV. At the three-month time point 87 percent of patients who received BIT225 in addition to standard of care (SOC), interferon alfa-2b plus ribavirin (IFN/RBV), were clear of virus, compared to 63 percent of those receiving IFN/RBV alone.
Key new data that will be presented include results from the week 48 follow-up of trial participants. These latest results demonstrate that 100 percent of patients who received 400mg dose of BIT225 in addition to IFN/RBV maintained a sustained virological response (SVR), with virus levels below the limit of detection. Patients who received 200mg of BIT225 in addition to IFN/RBV had 87.5 percent SVR, while patients who only received treatment with IFN/RBV had 75 percent SVR.
The 48-week data extends the previous three-month data, and demonstrates that BIT225 appeared to continue to provide additional benefit to patients after the conclusion of dosing.
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.
As well as being synergistic with current approved SOC HCV treatments, preclinical studies have demonstrated that BIT225 also works well in vitro with some polymerase inhibitors, another new drug class in clinical development.
BIT225 is also in development for treatment of HIV, with a phase Ib/2a trial currently in progress. BIT225 offers a unique opportunity for potential use in the HIV/HCV co-infected population. A trial in this patient population is anticipated to commence before the end of 2012.