NC-005 is a Phase 2B trial of the BPaZ and BPaMZ regimens to further explore its potential to be an improved TB treatment. This trial includes people with drug-sensitive as well as people with some forms of multidrug-resistant TB.
TB Alliance and its partners are conducting NC-005, a Phase 2B trial of the BPaZ and BPaMZ regimen to further explore their potential to be an improved TB treatment. This trial includes people with drug-sensitive as well as people with some forms of multidrug-resistant TB. It will be conducted at 10 sites across Uganda, South Africa, and Tanzania. If successful, the results of NC-005 will give way to a global Phase 3 trial that could lead to the worldwide registration of the BPaZ and/or BPaMZ treatment.
NC-005 is supported by the efficacy and safety of BPaZ that has thus far been proven in a two-week clinical study completed in 2014, as well as pre-clinical models. The two-week study found that the BPaZ regimen killed more than 99% of TB bacteria over the course of 14 days, and that the treatment was safe. The NC-005 study will now test this regimen’s efficacy and safety over two months of treatment.
The trial will also investigate a simpler dosing scheme for bedaquiline that could lead to fewer pills and an overall less complicated treatment for patients as well as answer additional questions that could lead to expanded use of this important drug as part of a novel regimen.