Ann: BIT225 Phase 2 HIV-1 Clinical Trial Fully Recruited, page-3

1
Level 2, 66 Hunter Street
Sydney NSW 2000
Tel: (61-2) 9300 3344
Fax: (61-2) 9221 6333
E-mail: [email protected]
Website: www.biotron.com.au
23 August 2022
The Manager - Companies
ASX Limited
20 Bridge Street
SYDNEY NSW 2000 (2 pages by email)
Dear Madam,
BIT225 PHASE 2 HIV-1 CLINICAL TRIAL FULLY RECRUITED
The Directors of Biotron Limited (‘Biotron’ or ‘the Company’ are pleased to advise that a Phase
2 HIV-1 clinical trial (BIT225-010; ACTRN12621000937819) of its lead antiviral drug, BIT225, is
fully recruited.
The trial, which is in progress at sites in Bangkok and Chiang Mai, Thailand, is a Phase 2, multi-
centre, randomised, placebo-controlled, double-blind study of BIT225 in HIV-1 infected, treatment
naïve people commencing standard antiretroviral treatment (i.e. approved anti-HIV-1 drugs;
ART). The study is designed to determine the safety and efficacy of 200 mg BIT225 administered
daily for 24 consecutive weeks.
As per the clinical trial protocol, a total of 27 individuals, randomly assigned on a 2:1 ratio to
receive BIT225 (n=18) or placebo (n=9), have been enrolled in the study. At the conclusion of
the trial, everyone will remain on ART as per standard treatment protocols.
The trial was undertaken to confirm and further characterise the positive outcomes reported from
previous clinical trials of BIT225 in this population and to extend the duration of treatment.
Previous clinical data indicated that treatment for 12 weeks with BIT225 in newly diagnosed HIV-
infected people starting ART significantly improved key markers of immune dysfunction, which
indicated a boosting of the immune system against HIV-1.
This current trial is expected to provide additional key information on the impact of BIT225 on
HIV-induced immune dysfunction as well as important safely information about dosing over an
extended period in this patient population (24 weeks in the current trial versus 12 weeks in a
previous completed trial).
The clinical phase of the trial (last patient, last dose) is scheduled to be completed in February
2023. Blood samples collected during the study will then be analysed. Once all analyses are
complete, the trial database will be locked and the results subject to statistical evaluation. The
study will then be unblinded and outcomes reported. Preliminary results are anticipated in mid-
2023.