October 16, 2012

Biotron Limited to report new clinical data from BIT225 Hepatitis C Phase 2a trial in a late-breaking presentation at the AASLD 2012 annual conference


- 100% of HCV trial patients receiving 400mg of BIT225 daily for 1 month, had undetectable virus at the 48 week time point

Sydney, NSW, Australia, October 16, 2012 - Biotron Limited ('Biotron'), a clinical-stage drug development company focused on development of new generation antiviral drugs, today announced that the Company will report new clinical data from its Phase 2a 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, USA.

Previously released data from the 28 day Phase 2a 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% 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% of those receiving IFN/RBV alone.

The abstract titled “High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral
activity and tolerability of BIT225 plus pegylated interferon alfa 2b and weight-based ribavirin for 28 days in HCV treatment-na├»ve patients" will be presented in a late-breaking presentation on November 12 at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD, which will take place from November 9-13 in Boston, Massachusetts.

Key new data that will be presented include results from the week 48 follow-up of trial participants. These latest results demonstrate that 100% 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% SVR, while patients who only received treatment with IFN/RBV had 75% 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 1b/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


No comments:

Post a Comment