great result from biotron

SUCCESSFUL HCV TRIAL RESULTS
The Directors of Biotron Limited are pleased to announce the successful completion of its proof-ofconcept
study of BIT225 in Hepatitis C virus (HCV) infected subjects.
• Study meets primary endpoint of safety and tolerability.
• Several subjects receiving highest dose of BIT225 had significant reduction in viral loads.
The data from this Phase Ib/IIa clinical trial (Protocol BIT225-003) indicate that BIT225 has met its
primary end point of safety and tolerability in subjects dosed twice daily for 7 days. BIT225 was well
tolerated with no serious adverse events reported and no discontinuations from the study.
The secondary objectives were to assess the pharmacokinetics of BIT225 and to assess the antiviral
efficacy of BIT225 in these patients. Preliminary analysis of the pharmacokinetic profile of BIT225
demonstrated sustained plasma levels of BIT225 that are within the potential therapeutic range and are
consistent with the potential for once or twice daily oral dosing.
BIT225 has also met the objective of antiviral efficacy, which was assessed by measurement of viral load
in the plasma of the subjects. Preliminary statistical analysis of viral load reductions, as measured by the
mean change in virus levels from baseline at Day 0 through to the end of the study at Day 21, indicate
that the effect of BIT225 treatment on the 200 milligram cohort as a group was modest but highly
significant compared to placebo controls. On an individual level, 3 of the 6 subjects receiving 200 mg of
BIT225 had significant reductions in viral loads.
While the reductions in viral loads were modest (with a maximum of 0.5log10) they were statistically
significant, and importantly, demonstrated that BIT225’s previously reported in vitro activity translates
to in vivo efficacy in a clinical setting.

"We are encouraged by the results of this trial, with 50% of subjects receiving 200 mg of BIT225
showing significant reduction in viral loads. We know from previous preclinical studies that BIT225’s
potency is significantly enhanced in combination with interferon-alpha and ribavirin, so we would expect
greater efficacy levels in future combination studies" said Dr Michelle Miller, CEO and Managing
Director. "This current result demonstrates proof-of-concept, i.e. that BIT225 is able to target and reduce
HCV replication in a clinical setting."
This study is the first demonstration of efficacy with a new class of anti-HCV drug, targeting the p7
protein of HCV.
There is a demand for new classes of antiviral drugs in HCV treatment; the current standard of care
(interferon-alpha and ribavirin) is ineffective in around 50% of cases and is often associated with severe
side effects, and the use of new classes of HCV drugs in development known as protease and polymerase
inhibitors lead to rapid resistance when used on their own. To increase the barrier to generating drug
resistant virus, future HCV treatment is likely to involve cocktails of several specific antiviral drugs, and
BIT225 has the potential to be included in such a combination as it has demonstrated high degrees of
synergism with other HCV treatments in cell culture models.
With the successful completion of this proof-of-concept study in HCV-infected patients, Biotron plans to
advance BIT225 into a 14 day dose ranging study in combination with the current standard of care,
interferon-alpha and ribavirin.
Biotron anticipates presentation of data from this trial at a forthcoming international conference.
About BIT225
BIT225 is an investigational, orally-administered,