Tuberculosis is one of the world’s oldest and deadliest disease, and to this day remains a leading global health threat. TB Alliance's ultimate vision is to have a transformative impact on the disease by introducing an ultra-short, simple, and affordable TB regimen that works in virtually all people with tuberculosis. Throughout 2022, we have worked with partners to advance innovative approaches to finding new ways to treat and cure TB.
ZeNix Trial Results Published in the New England Journal of Medicine
The results of TB Alliance’s Phase 3 ZeNix clinical trial revealed that the BPaL treatment remains effective against highly drug-resistant strains of TB with reduced dosage and/or duration of the linezolid component of the regimen. Along with the maintenance of efficacy, there was a decrease in linezolid-associated side effects that accompanied the reduced dosage or duration of linezolid. The results from the trial were published in the New England Journal of Medicine. ZeNix enrolled 181 participants at 11 sites across Georgia, Moldova, Russia, and South Africa. The results contributed to new WHO treatment guidelines issued in 2022.
TB Alliance Spearheads Open Development Model with TB Drug Candidate, Sutezolid
TB Alliance has implemented an open development approach to advance the Phase 2 TB drug candidate, sutezolid, which could be a component of a next-generation TB regimen. We have made sutezolid available for study by all researchers who commit to making their results available to the broader TB research community. This novel approach has contributed to three clinical trials that are expected to begin in 2023.
Working with Consortia
There is a constant need to innovate in finding solutions to the world’s most difficult global health problems. In recent years, advancing the fight against TB has taken a new approach in drug development, which is a consortia-based model. TB Alliance is involved in several consortia – including the Innovating Health Initiative (formerly Innovative Medicines Initiative), which runs programs like EU-PEARL, UNITE4TB, EAR4TB, and the IMI AMR Accelerator. TB Alliance is also a member of PAN-TB, a consortium led by the Bill & Melinda Gates Foundation. These consortia bring together research partners around the world to pool resources and expertise to help advance the discovery and development of potential new drug candidates and compounds. Innovative funding mechanisms like these consortiums are more critical than ever before, as the COVID-19 pandemic shined a light on both the urgent need for increased R&D of new drugs, vaccines, and diagnostics to combat emerging and re-emerging diseases and the need for innovative partnerships in discovering, developing and delivery new tools.
It is currently estimated that 30,000 children develop drug-resistant TB (DR-TB) annually, but fewer than 10-15% are treated. Even for children who can access treatment, current regimens are still too long, complex, toxic, poorly tolerated, and simply not acceptable. The BENEFIT Kids program, funded by UNITAID and led by Stellenbosch University in collaboration with TB Alliance, aims to address this lack of high-quality evidence on and access to prevention and effective, tolerable treatment of DR-TB in children. In December 2023, BENEFIT Kids launched a series of pivotal publications in the International Journal of Tuberculosis and Lung Disease (IJTLD) highlighting the importance of child-friendly formulations for DR-TB, including extemporaneous formulations for pretomanid, delamanid, clofazimine, and bedaquiline.
SPOTLIGHT: The Project to Accelerate New Treatments for Tuberculosis
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration announced a program to support the progression of two investigational TB combination treatment regimens into Phase 2 clinical development. The collaboration will evaluate whether the novel regimens, which combine registered products and not yet approved new chemical entities, can effectively treat active pulmonary TB using substantially shorter treatment durations than existing drug regimens, with the goal of identifying a regimen suitable for Phase 3 development.