Posted: 24 August 2022
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, multicentre, 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 HIVinfected 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 mid2023.
Biotron’s Managing Director, Dr. Michelle Miller said, “We are pleased to have completed enrolment of all patients in a very short time frame. This is an excellent achievement, especially taking into consideration the significant challenges in undertaking clinical trials during COVID lockdowns. We also have a second HIV-1 Phase 2 trial underway here in Australia and we look forward to completing recruitment of that study shortly.”
