Biotron confirms start of new COVID-19 human study

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Biotron (ASX:BIT) has announced the commencement of a human clinical trial of its lead antiviral drug BIT225 against COVID-19.

The company said the COVID-19 trial of BIT225 has been of approved as a sub-study in the ongoing Phase 2 BIT225-010 HIV-1 clinical trial currently in progress at sites in Thailand.

Twenty-seven people have been enrolled on the BIT225-010 HIV-1 clinical trial. The company said any of these people who are diagnosed with symptomatic COVID-19 infection during the six-month treatment period will be enrolled in the COVID-19 sub-study. SARS-CoV-2 viral load and clinical symptoms will be intensively assessed over a 28-day period.

Participants included in the COVID-19 sub-study will continue on the HIV-1 trial throughout the sub-study and after the sub-study’s conclusion.

Biotron said BIT225 has demonstrated both antiviral and favourable immunomodulatory effects in its current development for HIV-1 and has recently demonstrated both antiviral, immune-modulatory and clinical benefits against SARS-CoV-2 in an accepted murine model of disease.

Managing director Dr Michelle Miller said, “We are very pleased to be able to incorporate an assessment of BIT225 against SARS-CoV-2 infection and COVID-19 into our ongoing Phase 2 HIV-1 clinical trial. There are minimal additional costs associated with the sub-study and no expected impact on the timing of the results of the BIT225-010 trial as it is fully recruited.

"The sub-study provides a speedy and cost-effective pathway to explore the potential benefit of BIT225 against SARS-CoV-2 in a high-risk patient population. We look forward to completing the study and reporting results in mid-2023.”