Biotron buoyed by early trial success of BIT225 HIV-1 antiviral drug

Biotron (ASX: BIT) has obtained promising early results from a phase 2 clinical trial of the company’s lead antiviral drug BIT225.

Preliminary analysis of trial data indicates BIT225 is having a unique effect beyond that seen with the current standard.

It has also been assessed that the primary objectives of the trial have been met, providing confirmation and extension of the results of previous trials in people infected with human immunodeficiency virus (HIV)-1.

HIV-1 is the most common type of HIV.

The virus attacks the immune system by destroying CD4 cells, which help fight infections.

This can lead to acquired immune deficiency syndrome, more commonly known as AIDS.

Primary objectives met

Biotron’s managing director Dr Michelle Miller said the primary objectives of the trial were to evaluate the safety, efficacy and impact of BIT225 administered with cART on selected inflammatory and immune markers in this patient population.

“The positive outcomes from this trial further our understanding of BIT225,” Dr Miller said.

“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 double-blind, placebo-controlled phase 2 trial was designed to characterise the effect of BIT225 added to a standard of care antiretroviral therapy in 27 treatment-naïve people infected with HIV-1.

Study participants were followed for a one-month period following 24-weeks of BIT225 or placebo dosing, with all individuals continuing on cART as per standard treatment guidelines post-study.

Rapid viral reductions

Preliminary analysis of the HIV-1 plasma viral load data for the BIT225-010 trial suggests that the addition of BIT225 to cART results in a more rapid reduction in plasma virus levels during the second phase of viral decay, compared to cART alone.

Early analysis suggests the rates of decline of the plasma HIV-1 viral loads were statistically greater in the BIT225 group compared to the placebo.

Preliminary studies of blood immune cell populations also showed changes in specific immune cell populations in the BIT225 group compared to cART alone.

Statistically-significant differences were observed between treatment groups in levels of sub-populations of CD4 and CD8 T cells as well as in CD16/56 NK cells, a key cell type combating viral infection.

Significant differences were also observed in the change from baseline between the BIT225 and placebo (cART alone) for several immune activation and inflammatory markers.

Biotron says these changes are consistent with those seen in earlier trials and suggest a possible immune-modifying effect of BIT225 when used with cART.

Significant cost burden

28,870 people were estimated to be living with HIV in Australia at the end of 2022, according to Health Equity Matters.

Their modelling shows investment in HIV can avert over 6,000 new infections and save $1.4 billion by 2030.

Australia has virtually eliminated HIV transmission among sex workers and people who inject drugs, with current prevalence highest among gay and bisexual men.