Biotron (ASX:BIT) has provided an update on the progress and timing of its proof-of-concept HIV-1 clinical trial.
The trial is a phase 2, multi-centre, randomised, placebo-controlled, double-blind study of the company's lead molecule, BIT225, and combination antiretroviral therapy (cART) Atripla (tenofovir and emtricitabine and efavirenz) in patients with HIV.
The trial patients had not previously been on anti-HIV-1 treatment and were commencing a cART regimen. They received cART in addition to 12 weeks with BIT225 or placebo.
The objectives of the trial are to assess the impact of BIT225 in combination with cART on plasma and intracellular HIV-1 virus levels, and the impact of BIT225 on HIV-1-induced immune activation.
The company previously advised a novel diagnostic assay is being utilised to demonstrate the potential impact of BIT225 on HIV-1 virus levels. It said it had expected results from this specialised virology assay to be available by mid-2018.
"This work is being done by a third party that has developed the assay and is completely independent from Biotron," it said.
"They have indicated that there have been some delays due to other commitments and that the Biotron results are now expected by the end of September 2018. The samples and the results of the analyses remain blinded until this work is complete.
"In parallel, analyses have been continuing to assess the impact of BIT225 on HIV-1-induced immune activation. Data from this key component of the trial have been compiled, and are being reviewed by an independent, internationally renowned HIV immunologist based in Europe. It is expected that this review will be available at the same time as the results from the virology assay."
According to Dr Michelle Miller, Biotron’s CEO and managing director, “The virological assay that has been developed is cutting edge, allowing us to look for the first time at active virus levels within specific reservoir cells.
"Together, the data from these virological and immunological assays have the potential to demonstrate that BIT225 can either protect or eliminate HIV-1 from monocytes.
"These are key elements in our strategy to demonstrate that BIT225 has the potential to form a key component of an overall 'cure strategy' for HIV-1. While disappointed that there has been a delay, we look forward to reporting results from this exciting study as soon as possible."