In this study, the bactericidal activity and safety of 3 doses of TBAJ876 (25 mg, 50 mg, and 100 mg) in combination with Pretomanid 200 mg and linezolid 600 mg will be compared to the standard of care (SOC) 2HRZE, after 8 weeks of treatment to determine the optimal dose of TBAJ876 to carry forward in subsequent phases of development. The trial will also examine the bactericidal activity of B-Pa-L compared to 2HRZE and TBAJ876-Pa-L over 8 weeks and examine the efficacy and safety of the 26-week B-Pa-L regimen compared with the SOC (2HRZE/4HR) in participants with DS-TB. These data will provide insight into the optimal duration of treatment required for the TBAJ876-Pa-L regimens, and support the planning for a future phase 3 trial.
Expected impact: This trial may lead to eventual registration of a new second generation diarylquinoline, as part of a regimen, with the potential of improved potency/efficacy compared to the currently approved diarylquinoline, reduced treatment duration, potential to treat Bedaquiline-resistant MTB infections, and improved tolerability
Recruitment rate: 140%
Retention rate: 90.5%
