6 March 2014
The Manager Companies
20 Bridge Street
Sydney NSW 2000
- Study evaluated BIT225 in patients co-infected with HIV and HCV
- All HCV genotype 3 patients completing treatment are virus-free at 24 weeks
- Preliminary data from subset of patients shows benefit extends out to 48 weeks
Sydney, Australia, 6 March 2014 – Australian drug development company Biotron Limited
(ASX:BIT) today announced additional interim positive data from a key phase 2 trial of its lead
antiviral drug, BIT225, in patients co-infected with HIV and Hepatitis C virus (HCV).
Analysis of blood samples from patients indicated that all of the HCV genotype 3 patients completing treatment are virus free at the 24 week (6 month) time point. This extends previous data
that showed patients had undetectable virus levels at 12 weeks.
Response to treatment at this time point is generally a good indication of final outcome at 48 weeks. Preliminary data from patients who have completed 48 weeks of treatment indicate that they remain virus free at this key time point.
Under the protocol of this open label pilot study, 12 patients received IFN/RBV for 7 days before
commencing treatment with BIT225. They then received 300 mg BIT225 twice daily plus IFN/RBV
for 28 days. After that time, patients continued to take IFN/RBV for 48 weeks.
Biotron Managing Director Dr Michelle Miller commented; "This 24 week data further validates 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 lower
response rates to treatment with existing standard therapies."
In vitro assays have shown that BIT225 has pan-genotypic activity. Previous clinical trials of
BIT225 have focused on patients infected with the genotype 1 variant of the virus, which is the most
common genotype in Western populations. This data further extends the Company's clinical data
portfolio to include genotype 3, which is endemic in south-east Asia.
In HCV, BIT225 targets the p7 protein which is responsible for virus assembly. BIT225 also
impacts on the assembly of the HIV virus and specifically targets the virus in reservoir cells. No
existing therapy works in this way.
Dr Miller further commented; "Both the HIV and HCV viruses present substantial challenges and there is global demand for novel therapeutics. We look forward to progressing commercialisation of this important compound as a valuable new therapy that is synergistic with current and future treatment strategies."
Dr Michelle Miller
+61-2 9805 0488 +61-(0)412313329
+61-3 9620 3333