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EU funding (€7,098,991): EX-DR TB: Elimination of Extensive Drug Resistance Through better Regimens for TB Hor25 Jun 2025 EU Research and Innovation programme "Horizon"
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EX-DR TB: Elimination of Extensive Drug Resistance Through better Regimens for TB
In 2022, the World Health Organization (WHO) recommended bedaquiline (BDQ)-based, all-oral regimens including pretomanid (Pa), linezolid (L), and moxifloxacin (M) (BPaLM), lasting 6-9 months However, BDQ-resistance is rising dramatically and threatening these advancements. Mozambique has reported BDQ resistance in 28% of MDR-TB isolates in 2024, up from 3% in 2016 and at 10% in South Africa (Ndjeka N, personal communication). Spread of BDQ-R TB must be slowed by antibiotic stewardship through more rapid, accurate, and near-patient diagnostics, and optimized management; until new treatment options with drugs that have no pre-existing resistance or are able to overcome small shifts in MIC will be available. The proposed EX-DR TB project includes diagnostic capacity strengthening, adapting treatment recommendations, and a trial of two new regimens composed of new drugs. The EDCTP EX-DR TB project will: 1. Develop treatment recommendations by a Delphi process with stakeholders - to make use of targeted next generation sequencing (tNGS) that is being rolled out by most national TB programmes - this will yield short-term benefit for patients and NTPs; and will slow the spread of BDQ-resistant bacteria; 2. Rigorously evaluate two treatment regimens composed of new drugs, in a phase 3 clinical trial conducted to the highest regulatory standard – this will be the main focus of EX-DR TB. The trial objective will be to move a regimen towards regulatory approval by FDA and/or EMA, and WHO if supported by results. Thus, EX-DR will create the tools for containing the nascent epidemic of BDQ-R TB and make them available to healthcare providers and TB Programmes. EX-DR TB will be embedded in a larger coalition of funders and partners focused on implementing and evaluating diagnostics and performing the trial beyond of the EDCTP funded area.
Funded Companies:
| Company name | Funding amount |
| GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON PROFIT ORGANISATION | ? |
| Baylor College OF Medicine Childrens Foundation Eswatini | €968,707 |
| City St Georges University of London | €262,085 |
| FORSCHUNGSZENTRUM BORSTEL LEIBNIZ LUNGENZENTRUM | €257,330 |
| Glaxosmithkline Investigacion y Desarrollo SL | €0.00 |
| Institutia Medico-Sanitara Publica - Institutul DE Pneumologie Chiril Draganiuc | €445,760 |
| Instituto Nacional de Saúde | €1,597,136 |
| KLINIKUM DER LUDWIG-MAXIMILIANS-UNIVERSITAT MUNCHEN | €0.00 |
| LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN | €0.00 |
| Ospedale SAN Raffaele Srl | €323,726 |
| STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM | €294,851 |
| University College London | €384,998 |
| University OF Cape Town | €1,446,275 |
| Uppsala Universitet | €175,660 |
| Wits Health Consortium (PTY) Ltd. | €942,464 |
Source: https://cordis.europa.eu/project/id/101190913
The filing refers to a past date, and does not necessarily reflect the current state. The current state is available on the following page: The Global Alliance for TB Drug Development Inc., New York, United States.
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