The Directors of Biotron Limited advised that all participants in the two Phase 2 HIV-1 clinical trials of the Company's antiviral drug BIT225 have completed dosing, marking the end of the clinical phase of the trials. As previously advised, the trials have been designed to generate data that extend the positive findings from previous clinical trials conducted by Biotron in which BIT225 was shown to have positive effects on key immunologic markers of improved health outcomes. The data will be central to demonstrating to potential pharmaceutical partners and regulatory authorities the safety and efficacy of BIT225 in patients with currently unmet medical needs.

The BIT225-011 Phase 2 HIV-1 trial that has been underway at sites in Sydney, Australia, including St Vincent's Hospital, Holdsworth House and East Sydney Doctors, is investigating the impact of BIT225 in HIV-infected people who have been taking approved anti-HIV-1 treatment (`ART') for an extended period with well-controlled HIV-1 infection but not achieved full immune reconstitution despite long term durably suppressive ART. This group, estimated to encompass more than one-third of the HIV-treated population, is at an increased risk of clinical progression to AIDS and other morbidities and has higher rates of mortality than HIV-infected patients who have attained full immune reconstitution. BIT225 was added to this group's ART treatment for a period of three months.

The endpoints for this trial include measurements of improved immune function and markers linked to immune reconstitution. The BIT225-010 Phase 2 HIV-1 trial that was run at sites in Thailand included people newly diagnosed as being HIV-1 positive but not yet commenced ART with BIT225 treatment or placebo continuing for six months in combination with ART. This extended dosing period allows for a more detailed investigation of immune changes observed in previously completed HIV-1 clinical studies with BIT225.

The endpoints for this trial include measurements of improved immune function and markers linked to immune reconstitution. With the clinical phase completed, focus is now on undertaking detailed laboratory analyses of all the samples collected during the trials. The assays are complex and will take several months to complete.

Once all the data is available, the study will be unblinded and the data subjected to statistical analyses. Preliminary results from the trials are anticipated to be available in mid-2023.