Biotron (ASX:BIT) has announced that a Phase 2 HIV-1 clinical trial of its lead antiviral drug, BIT225, is fully recruited.
The trial, which is in progress at sites in Thailand, is a Phase 2, multicentre, randomised, placebo-controlled, double-blind study of BIT225 in HIV-1 infected treatment naïve people commencing standard antiretroviral treatment. The study is designed to determine the safety and efficacy of 200 mg BIT225 administered daily for 24 consecutive weeks.
The company said a total of 27 individuals, randomly assigned on a 2:1 ratio to receive BIT225 (n=18) or placebo (n=9), have been enrolled in the study. At the conclusion of the trial, everyone will remain on ART as per standard treatment protocols.
It said previous clinical data indicated that treatment for 12 weeks with BIT225 in newly diagnosed HIV-infected people starting ART significantly improved key markers of immune dysfunction, which indicated a boosting of the immune system against HIV-1.
The clinical phase of the trial (last patient, last dose) is scheduled to be completed in February 2023. Blood samples collected during the study will then be analysed. Once all analyses are complete, the trial database will be locked and the results subject to statistical evaluation. The study will then be unblinded and outcomes reported. Preliminary results are anticipated in mid-2023.
Biotron’s managing director Dr Michelle Miller said, “We are pleased to have completed enrolment of all patients in a very short time frame. This is an excellent achievement, especially taking into consideration the significant challenges in undertaking clinical trials during COVID lockdowns. We also have a second HIV-1 Phase 2 trial underway here in Australia and we look forward to completing recruitment of that study shortly.”