PanACEA-BTZ-043-02 was an adaptive seamless phase 1b/2a study performed at two South African sites. In phase 1b, doses were escalated by increments of 250mg with pre-specified decision-rules for seamless transition; in phase 2a, patients were randomised to receive one of three different doses BTZ-043, or standard treatment. Bacterial killing was assessed in liquid culture from overnight pooled sputum samples. Food effect on BTZ-043 exposure was assessed in phase 1b, drug-drug-interaction potential by a probe drug cocktail or dolutegravir in phase 2a.
The study was completed in May 2022, with results presented in 2024. BTZ-043 was safe and efficacious over 14 days of dosing. BTZ-043 should be administered with food, and can safely be co-administered with important TB drugs and dolutegravir.
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