Duration: 2021-2028
UNITE4TB is a project of the Innovative Health Initiative aiming to bring about a new generation of urgently needed treatments for tuberculosis (TB), and to help guide their responsible and expedient uptake throughout national TB programmes of the world.
Bringing together 30 global partners, the UNITE4TB consortium is a shared effort between universities, private companies, and non-governmental organisations to discover and implement new tuberculosis (TB) treatment regimens. The consortium is a public-private partnership jointly funded by the European Federation of Pharmaceutical Industries and Associations and the European Commission, putting forward a total of €185 million towards developing these crucial new tools. The clinical trials at the heart of the project are testing two new chemical entities, GSK-656 (Ganfeberole), which interferes with the protein synthesis inside mycobacterium bacilli, and BTZ-043, a compound for interfering with cell wall synthesis. Both new compounds are undergoing phase 2 studies in South Africa, Spain, and Germany, with plans to rapidly upscale testing to further trial sites. Beyond this, UNITE4TB aims to integrate an adaptive trial design to more effectively test for future TB drugs, to establish new biomarkers of treatment success and models for predicting antimicrobial resistance, and to employ machine learning techniques in conjunction with its pharmacokinetic and pharmacodynamic models. By utilising these technologies at the vanguard of medical research, UNITE4TB aims to establish a new way of designing and organising clinical trials and to seek TB regimens which overcome the challenge of emergent drug resistance worldwide. Finally, UNITE4TB aims to stay engaged with major stakeholders to ensure that all new regimens resulting from the trial can be quickly and effectively taken up by national TB programmes around the world, and to ensure their responsible and urgent use for the millions who suffer from TB worldwide.
Project Leader
- GlaxoSmithKline
Partners
- London School of Hygiene and Tropical Medicine
- Oxford University
- Lancaster University
- University College London
- Liverpool University
- St Andrews University
- European Lung Foundation
- Uppsala University
- Radboudumc
- Lygature
- KNCV
- C-Path (Netherlands)
- C-Path (United States)
- TB Alliance
- UCSF
- Forschungszentrum Borstel
- Helmholtz
- Hamburg University
- TBNET
- Institut de Recherche Pour le Développement
- Instituto de Saude Publica Porto, Porto University
- FIND
- European Respiratory Society
- Universita’ Vita-Salute San Raffaele
- Università degli Studi di Milano
- TASK
- Otsuka
- Deutsches Zentrum für Infektionsforschung
- Klinikum of the Ludwig-Maximilians-Universität München
- Johnson & Johnson
Funding
- EFPIA
- European Union
Goal
To discover new treatment regimens for TB
Objectives
- To utilise new chemical entities (starting with GSK-656 and BTZ-043) in TB regimens and determine their suitability for Phase III trials.
Activities
- To develop an adaptive trial design appropriate for use in TB drug trials
- To ensure the rapid uptake of new regimens in national TB programmes worldwide
- To develop biomarkers of treatment success
- To develop tools to detect antimicrobial resistance to ensure the continued responsible use of the new chemical entities
- MACH is particularly engaged in the activities of work package 11 (Implementation, dissemination, communication):
- Engagement with stakeholders via annual meetings, regular e-mail communication, and joining regional TB meetings
- Writing and reporting the feedback of stakeholders for the consideration of the management and PSC of UNITE4TB
- Arranging workshops and bringing in external stakeholders to UNITE4TB events
General achievements
- Recruitment of patients on to the PARADIGM4TB and BTZ-043 DECISION trials
MACH accomplishments
- Published ‘Towards comprehensive clinical trials for new tuberculosis drug regimens: policy recommendations from a stakeholder analysis’ BMJ Global Health
- Chaired ‘How to ensure equitable access to UNITE4TB innovations?’ session at the UNITE4TB Annual Meeting 2024