Biotron’s Phase 2 trial confirms BIT225 HIV treatment potential
Biotron (ASX: BIT) has received further indications that its lead antiviral drug BIT225 is a potential candidate for the treatment of issues related to HIV.
The company has informed shareholders that preliminary analyses of data from a Phase 2 clinical trial of BIT225-011 suggest that the primary objectives of the test program have been met.
The open-label trial was designed to characterise the effect of BIT225 added to ongoing, suppressive standard of care antiretroviral therapy (cART) for 12 weeks in 20 HIV-1 infected, treatment-experienced participants who had achieved only partial immune reconstitution.
Primary objective
The trial’s primary objective was to evaluate the safety and tolerability of BIT225 in this patient population, as well as to determine the impact of the addition of BIT225 to cART on immune activation, inflammation and viral markers.
Preliminary analysis of the safety data has shown that a 200mg once-daily dose of BIT225 was safe and generally well-tolerated with no deaths or drug-related serious adverse events (AE).
The results confirmed what had been observed in previous trials, with the observed AEs attributed to BIT225 of similar incidence and mild severity.
Viral suppression
It was also found that all participants in the trial maintained viral suppression throughout the study, with baseline values for a range of immune activation assessed after an initial 4-week period and a subsequent 12-week treatment period.
Further observation found that significant differences in the change from baseline occurred during the BIT225 treatment period for several pre-specified immune markers and cell populations.
These included NK cells – a key cell type involved in combating viral infection – and T-regulatory cells, suggesting BIT225 has an immune-modifying effect when used with cART.
Unmet need
“Individuals who do not achieve full immune reconstitution following fully suppressive antiviral therapy represent an important portion of those with HIV infection,” said Professor Anthony Kelleher, a director of the Kirby Institute at the University of NSW.
“Studies suggest that immune non-responders (INR) represent 20% to 40% of those on current antiviral therapy.”
“These individuals are at enhanced risk for serious comorbid conditions including neurocognitive, cardiovascular, renal and hepatic disorders that impair quality of life and drive healthcare expenditures.”
Professor Kelleher added that the development of therapies for the INR is a clear unmet need and therapeutic approaches including HIV-1 viroporin antagonism – such as BIT225 – require testing in the clinic.
“The laboratory changes seen in this exploratory study, while not demonstrating a rise in CD4 cells, are of interest and may portend clinical impact.”
Modelling shows that investment in HIV treatments in Australia can avert over 6,000 new infections and save $1.4 billion by 2030.