Biotron (ASX:BIT) has announced that preliminary data analyses from the BIT225-011 Phase 2 clinical trial of its lead antiviral drug BIT225 indicate that the primary objectives have been met.
The company said the longitudinal, open-label Phase 2 trial was designed to characterise the effect of BIT225 (200 mg, once daily) added to ongoing, suppressive standard of care antiretroviral therapy (cART) for twelve weeks in twenty HIV-1 infected, treatment-experienced participants who had achieved only partial immune reconstitution.
The trial's primary objectives were to evaluate the safety and tolerability of BIT225 in this patient population and to determine the impact of adding BIT225 to cART on immune activation, inflammation, and viral markers.
Biotron said a preliminary analysis of the safety data has shown that BIT225 was safe and generally well tolerated at the 200 mg once daily dose, with no deaths or drug-related serious adverse events.
The company said baseline values for a range of immune activation, inflammation and viral assays were determined for each person during an initial four-week observation period. Subsequent values of the same markers were assessed during the 12-week treatment period with BIT225 and a four-week follow-up period after completion of BIT225 treatment.
All participants maintained viral suppression throughout the study. During the BIT225 treatment period, statistically significant differences in the change from baseline were observed for several prespecified immune markers and cell populations. These included NK cells, a key cell type involved in combating viral infection, and T-regulatory cells.
"Changes in these cell populations have been noted in previous trials with BIT225 and suggest a possible immune modifying effect of BIT225 when used with cART," it said.
Biotron managing director Michelle Miller said, “This trial extends our understanding of BIT225 and complements the results from the previous HIV trials. Viroporin-targeting drugs such as BIT225 uniquely combine immune modulation with antiviral activity and have the potential to address both the immune and viral pathogenesis of numerous viral infections in a clinically-relevant fashion.
"This study was a particularly complex and time-consuming trial. The results reported here are preliminary, and ongoing analysis of this BIT225-011 trial and the BIT225-010 HIV-1 trial in a treatment-naïve population will be reported when complete."