Sydney-based Biotron (ASX:BIT) has provided an update on its lead molecule, BIT225, in combination with Gilead's PBS-listed ATRIPLA (tenofovir and emtricitabine and efavirenz) for the treatment of HIV.
The company is studying the combination as part of a phase 2 trial in patients with HIV-1 infection.
The HIV-1-infected patients in the study were treatment naı̈ve and received ATRIPLA in addition to 12 weeks of BIT225 or placebo.
The trial is assessing the impact of BIT225 in combination with ATRIPLA on plasma and intracellular HIV-1 virus levels, as well as the impact of BIT225 on HIV-1-induced immune activation.
The company said final data is not available but that no patients in the trial withdrew from the highest drug dose group and no serious adverse events were reported.
"In addition, preliminary data indicate that there were no major interactions between BIT225 and the other HIV-1 drugs – this is a very important consideration for a new HIV-1 drug," it said in a statement. It added the efficacy is being assessed through the use of a new diagnostic assay.
"This assay has greater potential to conclusively demonstrate that BIT225 can specifically target reservoir cells that remain infected in the presence of current anti-HIV-1 drugs," it said.
"The assay is technologically challenging and time-consuming. However, the analyses form a key element in Biotron’s strategy of demonstrating that the addition of BIT225 to cART has the ability to be a key component of an overall cure strategy for HIV-1. "
The company said it will report on the trial outcomes once data from the assay are available and the results have been unblinded. "It is anticipated that results will be available before the end of the current financial year," it said.