INDEPENDENT REVIEW OF BIT225 TRIAL DATA SUPPORTS DEVELOPMENT IN...

INDEPENDENT REVIEW OF BIT225 TRIAL DATA SUPPORTS DEVELOPMENT
IN COMBINATION WITH NEW HCV DRUGS
Sydney, Australia, 6 July 2015: - Australian drug development company Biotron Limited (‘Biotron’ or the
‘Company’) has provided an update on its three-month dosing trial with its lead antiviral drug, BIT225.
A USA-based, independent Data and Safety Monitoring Committee (‘DSMC’) has reviewed key interim,
preliminary data from the three-month dosing study of Biotron’s lead antiviral drug, BIT225. It recommended that
future trials focus on patients infected with Hepatitis C virus (‘HCV’) genotype 3 (‘G3’). The recommendation
was to further study BIT225 in combination with other direct acting antiviral drugs (‘DAAs’). Current DAA
therapies for this group involve treatment for up to 24 weeks duration and response rates with G3 infections are
lower than for other HCV genotypes.

1]This DSMC recommendation is in line with Biotron’s proposed strategy to focus on specific HCV patient groups,
which include G3 patients. The Company has been progressing towards filing an investigational new drug (‘IND’)
application with the USA Food and Drug Administration (‘FDA’) for a trial of BIT225 in combination with one or
more DAAs in HCV G3 patients.

2]The phase 2, randomised, double-blind, placebo controlled study of BIT225 on 60 patients infected with HCV G1
or G3 is ongoing at several trial sites in Thailand. Patients received 400 mg of BIT225 twice daily for three months
in combination with current standard of care therapies - pegylated interferon alfa 2b and ribavirin (‘IFN/RBV’),
before continuing to receive standard of care out to 24 weeks (G3) or 48 weeks (G1).

3]The DSMC reviewed preliminary safety data for all subjects out to week 12 of the trial, marking the completion of
dosing with either BIT225 or placebo in combination with IFN/RBV. The adverse events seen in this study appear
to be in line with those seen in previous trials.

4]The Committee noted that more subjects in the BIT225 arms were
withdrawn from the study than in the placebo arms. Investigations are ongoing, but these withdrawals are likely to
be related to the higher than expected drug exposure with the new, capsule formulation used in this study,
compared to the formulation used in previous studies.{NO Problems here you just LOWER THE DOSE}..

5]Safety and pharmacokinetic (‘PK’) data from this trial are key to determining the dosage of BIT225 for use in
future studies. Modelling of this data is currently in progress,

6]but FUTURE  DOSAGES  are expected to be less than used[EASY DONE "" in this TRAIL''
.
7]A safety review of data from all trials is currently underway. This data will be used to generate
" A COMPLETE PAKAGE to enable submission of an IND application to the USA regulatory authorities.{GREAT NEWS}..

8]The DSMC also reviewed the preliminary data on the antiviral effect of BIT225. At the time of completion of
dosing with either BIT225 or placebo with IFN/RBV, i.e. week 12 of the trial, both arms had very good response
rates, with 96% of subjects in the BIT225 arm having more than 2 log reduction in virus levels, compared to 90% THIS is Important  2Log Reduction means the VIRUS has been reduced 20 FOLD that's 180% so we are saying that 96% of the subjects had a Virus REDUCTION OF 180% That's Massive..
of the placebo arm.

9] However, it is expected that virus levels may rebound in a proportion of patients receiving
IFN/RBV once they stop receiving treatment. For this reason, the key time point for analysis of an antiviral effect
for BIT225 is twelve weeks after completing all drug treatment, known as SVR12 (sustained virological response at
Week 12).

10]Patients with undetectable virus at this time are considered cured of HCV infection. The SVR12 time point for the
G3 cohort is mid-August 2015, and the SVR12 time point for the G1 cohort is February 2016.

11]The DSMC noted that sub-analyses of the trial data at this point in time may reveal further differences. Preliminary
analyses have indicated that subjects in the BIT225 arms cleared virus from plasma faster than those in the placebo
arm. These results support findings from previous trials of BIT225 and suggest the potential use of BIT225 in
combination with other DAAs to reduce treatment time.

12]The DSMC also noted that more patients than expected are failing treatment with the new DAAs and that this
population, which has very limited choices, may be an area of interest for BIT225 given its novel and different antiviral
mechanism of action.

13]Biotron expects to file an IND application with the USA FDA in 2H2015. This will enable further pivotal trials of
the drug to be conducted in the United States and will be a key milestone towards commercialisation.