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- Biotron (BIT) finishes recruiting patients for its phase two HIV-1 clinical trial of its lead antiviral drug BIT225
- The clinical trial is being conducted in Thailand and aims to determine the safety and efficacy of BIT225 on a daily basis for 24 consecutive weeks
- All up, 27 individuals are involved who all have HIV-1 and are just commencing standard antiretroviral treatment
- Biotron expects the trial will provide important information on BIT225’s impact on HIV-induced immune dysfunction and whether it can boost the immune system against HIV-1
- BIT shares are up 1.72 per cent to trade at 5.9 cents at 3:39 pm AEST
Biotron (BIT) has fully recruited patients for its phase two HIV-1 clinical trial of its lead antiviral drug.
The trial will be conducted at two sites in Thailand and aims to determine the safety and efficacy of administering 200 milligrams of BIT225 on a daily basis for 24 consecutive weeks.
The study will involve 27 individuals with HIV-1 who haven’t previously been treated but are commencing standard antiretroviral treatment (ART).
Eighteen patients will receive BIT225 and nine will receive a placebo. Once the trial is complete, everyone will remain on ART.
Previous clinical data suggested that treating newly diagnosed HIV-infected people with BIT225 for a 12 week period who are starting ART “significantly” improves key markers of the immune dysfunction. This indicates a boost of the immune system against HIV-1.
Managing Director Dr Michelle Miller said Biotron is pleased to have completed recruitment in a short amount of time.
“This is an excellent achievement, especially taking into consideration the significant challenges in undertaking clinical trials during COVID lockdowns,” Dr Miller said.
“We also have a second HIV-1 phase two trial underway here in Australia and we look forward to completing recruitment of that study shortly.”
Biotron expects the clinical trial will be completed in February next year and blood samples will then be analysed.
The company expects to receive preliminary results mid next year.
BIT shares were up 1.72 per cent to trade at 5.9 cents at 3:39 pm AEST.
