Biotron (ASX:BIT) has commenced two clinical trials with its lead antiviral drug BIT225 in HIV-1-positive populations.
The company said they build on favourable results from the completed BIT225-009 Phase 2 clinical trial in which BIT225 was shown to induce immunomodulation effects and key markers of improved health outcomes. The two new trials are designed to investigate further the immune changes observed in the BIT225-009 study.
BIT225 will be tested in people who have been taking approved anti-HIV-1 treatment for an extended period with well-controlled HIV-1 infection.
It has been previously tested in newly infected, antiretroviral treatment-naïve people commencing treatment for the first time. The new trial, BIT225-011, will include people who have not achieved full immune reconstitution despite long term durably suppressive ART.
BIT225 will be added to the BIT225-011 subjects’ ART for a period of 12 weeks, after which time they will remain on antiretroviral treatment as per standard treatment protocols.
Biotron managing director Dr Michelle Miller said, “We are extremely pleased to be undertaking this study here in Sydney, Australia with such an experienced, internationally recognised team. Initiating this clinical trial is an important step towards demonstrating the clinical benefit that BIT225 could bring to the treatment of HIV-1, especially in a still at-risk group. BIT225’s unique dual action in targeting HIV-1 in cellular reservoirs and improving immune functions has the potential to improve health outcomes in this population.”
The other new trial, BIT225-010, has also commenced at two sites in Thailand. This study will include individuals newly diagnosed as being HIV-1 positive but who have not yet commenced ART.
The study participants will have BIT225 or placebo added to the newly-approved standard of care ART at the beginning of treatment for a period of 24 weeks. The dosing period is twice as long as the previously successful BIT225-009 trial and allows for a more detailed investigation of immune changes observed in that study.