A Novel pan-TB Regimen Targeting Both Host and Microbe: Key Results
This project RIA2019AMR-2647 is part of the EDCTP2 Programme supported by the European Union
Tuberculosis is a leading global cause of morbidity and mortality. Even if cured, most patients are left with permanent lung damage that impairs lung function and shortens long-term survival. This project conducted a trial of the first 4-month TB regimens crafted to meet WHO criteria for a pan-TB indication and intended to promote recovery of lung function. The regimens included the approved drugs bedaquiline (B) and pretomanid (Pa), the investigational oxazolidinone sutezolid (U, at doses of 1200 and 1600 mg once daily), and the nutritional supplement and essential medicine N-acetylcysteine (NAC or N, at 1800 mg twice daily). The trial enrolled 378 participants with rifampin-susceptible TB from July 2023 to Feb 2025 at sites in South Africa, Tanzania, and Mozambique. The median age was 33. 33% were HIV seropositive. The mean FEV1 on entry was 72% of predicted. Treatment arms were balanced with regard to radiographic extent of disease and sputum MTB burden. The key preliminary findings, reported as a late-breaking poster at the 2026 meeting of the American Thoracic Society, were that, compared to standard 6-month TB treatment, 2 arms (BPaU1200 and BPaU1600N) met noninferiority criteria for durable cure as 4-month regimens, and one arm (BPaU1600N) arm showed superior recovery of FEV1. Final trial results will be presented orally at the upcoming Union World Conference on Lung Health in Rio de Janeiro. These findings represent an important advance in the development of new treatments that can potentially restore lung health and longevity to patients with tuberculosis.
Links for more information:
Media interview at ATS meeting
panTB-HM final consortium meeting
Participating Organizations
Aurum is an independent non-profit institute dedicated to solving health problems of the poor through research and implementation. It is based in Johannesburg, South Africa. Aurum has overall responsibility for this project.
Ludwig Maximilian University of Munich is a German public research university. LMU is responsible for Data Management and Statistics, and will assist in spirometry training.
The Wits Health Consortium (Pty) Limited (WHC) is wholly-owned by the University of the Witwatersrand. Its Clinical HIV Research Unit will participate in clinical activities in this project.
The Instituto Nacional de Saúde (INS), Ministry of Health, Mozambique, is a public health research institution, focusing on epidemiological surveys and conduct of clinical trials. It will participate in clinical activities in this project.
The National Institute for Medical Research - Mbeya Medical Research Center is a leading institution conducting clinical trials in Africa in the areas of TB, HIV, and malaria. NIMR-MMRC will participate in clinical activities in this project.
Radboud University Medical Centre specializes in patient care, scientific research, teaching and training. Its Department of Pharmacy will perform PK analyses and PK/PD modeling for this project.
Stellenbosch University is amongst South Africa's leading tertiary research institutions. Its Division of Molecular Biology and Human Genetics will perform MTB whole genome sequencing for this project.
Sequella is a clinical-stage pharma company that develops new and better antibiotics to address drug resistant bacterial, fungal, and parasitic infections.
This project [RIA2019AMR-2647] is part of the EDCTP2 Programme supported by the European Union.
Funding
