Biotron has announced preliminary analyses of data from the BIT225-010 Phase 2 clinical trial of its lead antiviral drug BIT225.
The company said the data provide confirmation and extension of the results of previous trials in people infected with HIV-1.
The double-blind placebo-controlled Phase 2 trial was designed to characterise the effect of BIT225 added to a standard of care antiretroviral therapy (cART - dolutegravir, tenofovir disproxil fumarate and emtricitabine) in twenty-seven treatment naïve people infected with HIV-1.
Study participants were followed for one month following 24 weeks of BIT225 or placebo dosing. All individuals continued on cART as per standard treatment guidelines post-study.
The trial's primary objectives were to evaluate the safety, efficacy and impact of BIT225 administered with cART on selected inflammatory and immune markers.
Biotron said the preliminary safety data analysis has shown that BIT225 is safe and generally well tolerated. The efficacy of BIT225 was determined by assessing plasma viral loads and changes to blood immune cell populations. The company said the HIV-1 plasma viral load data for the BIT225-010 trial suggests that adding BIT225 to cART results in a more rapid reduction in plasma virus levels during the second phase of viral decay, compared to cART alone. Preliminary analyses of blood immune cell populations also showed changes in specific immune cell populations in the BIT225 group compared to cART alone.
Biotron managing director Dr Michelle Miller said, "The positive outcomes from this trial further our understanding of BIT225. The blood (plasma) viral load data in particular should be highlighted, as it suggests that BIT225 is having an impact on a critical phase of viral decay when latent reservoirs are established. Current cART is efficient at rapidly and durably reducing virus levels in the blood, but this does not translate into clearance of latent reservoirs. The observed changes to immune markers and cells further the results from the previous 009 trial and suggest the utility of targeting viroporins as a new class of antiviral drugs.
"The results reported here are preliminary, and ongoing analysis of the BIT225-010 study, as well as its companion study, BIT225-011 in HIV-1 chronically infected individuals, will be reported when complete.
"We would like to thank the principal investigators, trial sites, CROs, and most importantly, the trial participants who enrolled in the study.”