The Directors of Biotron Limited (‘Biotron’ or ‘the Company’) are pleased to advise that the Company has commenced a human trial of its lead antiviral drug BIT225 against COVID-19.
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 (ACTRN12621000937819) currently in progress at sites in Thailand.
The COVID-19 sub-study was approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok which is responsible for ethics approval at the HIV-NAT site where the trial is underway.
Twenty-seven people have been enrolled into the BIT225-010 HIV-1 clinical trial. 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. The BIT225-010 study’s randomisation and blind will be maintained throughout the COVID-19 sub-study. Primary and secondary objectives of the trial remain unchanged from those previously announced on 1 Nov 2021. The changes in SARS-CoV-2 viral loads and COVID-related symptoms have been incorporated as exploratory objectives.
BIT225 has demonstrated both antiviral and favourable immunomodulatory effect in its current development for HIV-1 (ASX announcements 28 September 2018, 28 Novovember 2018, 3 December 2019, 12 March 2020) and has recently demonstrated both antiviral, immune modulatory and clinical benefit against SARS-CoV-2 in an accepted murine model of disease (ASX announcements 25 November 2021, 17 March 2022, 2 May 2022).
The sub-study will follow the same timetable as the parent HIV-1 trial. As previously advised (ASX announcement 23 August 2022) the BIT225-010 trial is expected to conclude in February 2023, with preliminary results anticipated in mid-2023.
Biotron’s 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 on-going Phase 2 HIV-1 clinical trial. There are minimal additional costs associated with the sub-study and no expected impact on 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.”