DSMC recommends continuation of Biotron's Phase II trial of BIT225 for HIV-1 infection

Biotron Ltd. (ASX:BIT) said an independent DSMC recommended continuation of the Phase II BIT225-009 trial of BIT225 to treat HIV-1 infection based on safety data from the first cohort of 9 patients. The trial will now enroll a second cohort of 27 patients.

The double-blind, placebo-controlled, Thai trial is evaluating once-daily 100 and 200 mg oral BIT225 plus combination antiretroviral therapy (ART) for 12 weeks in about 36 patients. The co-primary endpoints are HIV-1 plasma viral load and safety. Secondary endpoints include immune activation and pharmacokinetics. Data from the trial are expected late this quarter...