Clinical stage company Biotron (ASX: BIT) is preparing to present results from its ongoing phase 2 trial into its lead BIT225 drug at the annual Conference on Retroviral and Opportunistic Infections (CROI) this week with new data showing that BIT225 “unmasks” HIV-infected cells that remain in the body despite treatment with approved anti-HIV-1 drugs.
CROI is the leading international HIV-1 conference that brings together top basic, translational and clinical researchers from around the world to share and discuss the latest studies and important developments in HIV/AIDS research.
Due to concerns relating to the COVID-19 outbreak, this year’s conference is being held in an entirely virtual setting with all attendees collaborating online.
For the phase 2 trial, Biotron recruited 36 patients in a randomised, placebo controlled, double-blind study in Thailand. Participants were treated with 100mg and 200mg doses of BIT225 or placebo in addition antiretroviral therapy Atripla for 12 weeks.
The study concluded that “the addition of BIT225 to antiretroviral therapy resulted in unique stimulation of multiple arms of the innate immune system”.
Another conclusion made was that BIT225’s immune modulating effects “may have utility” in improving HIV-1 induced chronic immune activation outcomes and aid in future eradication strategies.
In previous phase 2 results, Biotron reported showed that its BIT225 therapy induced “statistically significant changes” to key immune cell populations with these changes said to be “not seen in this or other trials” with current approved anti-HIV-1 drugs.
Since completing the clinical trial and releasing positive results in late 2018, Biotron has continued to characterise the unique mechanism of action of its lead antiviral drug, BIT225.
According to Biotron, the latest data presented at CROI, further characterises the previously reported immune modulating effects of BIT225.
In its presentation, Biotron will explain how its data indicates that the addition of BIT225 to anti-HIV-1 drugs stimulates the innate immune system so that the body’s cells can recognise HIV-infected reservoir cells and take the necessary steps to eliminate any residual virus.
“The results are encouraging and may have profound implications for the future treatment and cure of HIV-1 infection,” the company said.