Summary
Tuberculosis kills around 1.5 million people annually, making it one of the leading causes of death worldwide. Treatment consists of a combination of drugs taken for at least six months, or even longer in patients whose disease is resistant to frontline treatments. The long treatment time, coupled with the side effects of some drugs, leads some patients to stop taking their antibiotics, and this contributes to drug resistance, which is on the rise. However, identifying new treatments and treatment combinations that could shorten the treatment time and tackle drug resistance is difficult and time-consuming.
The aim of UNITE4TB is to accelerate and improve clinical trials of combinations of existing and new drugs, with the goal of developing new and highly active treatment regimens for TB, including drug-resistant TB.
Between them, the partners have access to the majority of the most innovative anti-TB drugs that are at an advanced stage of development. The project will focus on phase 2 clinical trials, in which drugs are tested in patients with a view to gathering data on the drugs’ safety and efficacy as well as the best dosage and delivery method (e.g. tablet or injection). The project aims to develop a new approach to trialling TB drugs in phase 2 clinical trials. They will first use simulation tools to identify the optimal doses for each drug, then run a multi-arm, adaptive clinical trial of the best candidate regimens. The advantage of an adaptive trial is that many treatment regimens can be evaluated simultaneously, dramatically speeding up the trial process. To further speed up the process, the project will draw on existing global TB clinical trial networks with the capacity to rapidly enrol patients across four continents.
Using this approach, the project hopes to identify promising TB treatment regimens that could be further tested in phase 3 clinical trials, which typically involve a much larger number of patients than phase 2 trials.
The hope is that these regimens could ultimately become the global gold-standard for TB treatment, and so contribute to the goals of the World Health Organization’s End TB programme.
UNITE4TB is part of the AMR Accelerator programme.
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IMI has launched two separate projects that, when combined, represent the biggest effort to combat tuberculosis (TB) in history.###
UNITE4TB, launched in 2021, is the first and only initiative of its kind in the world. The project is building a platform for carrying out clinical trials of new drug combinations for TB. They will focus on phase 2 and 'phase 3-ready' clinical trials. The partners have access to the majority of the most innovative anti-TB drugs at an advanced stage of development and will jointly test their clinical candidates and share research results.
ERA4TB, launched in 2020, has a budget of €208 million and 31 partners, and is focusing on pre-clinical development of combination therapies from pre-clinical to phase 1-ready.
The methodology for both projects is the same. They are investigating the possibility of testing TB drugs in parallel as opposed to sequentially – the ‘racetrack’ concept – an approach that will help test the safety and efficacy of drug combinations of over a dozen drug candidates at the same time.
Both projects combined bring the total investment to almost €400 million. The hope is that these efforts will produce TB treatment regimens that could ultimately become the global gold standard.
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Participants
Show participants on mapEFPIA companies
- Glaxosmithkline Investigacion Y Desarrollo SL, Tres Cantos, Spain
- Janssen Pharmaceutica Nv, Beerse, Belgium
- Otsuka Novel Products GMBH, Munich, Germany
Universities, research organisations, public bodies, non-profit groups
- European Lung Foundation, Sheffield, United Kingdom
- European Respiratory Society, Lausanne, Switzerland
- Forschungszentrum Borstel Leibniz Lungenzentrum, Borstel, Germany
- Foundation For Innovative New Diagnostics, Geneva, Switzerland
- Global Alliance For Tb Drug Development Non Profit Organisation, New York, United States
- Helmholtz Zentrum Muenchen Deutsches Forschungszentrum Fuer Gesundheit Und Umwelt GMBH, Neuherberg, Germany
- Institut De Recherche Pour Le Developpement, Marseille, France
- Koninklijke Nederlandse Centrale Vereniging Tot Bestrijding Der Tuberculose (Kncv), Den Haag, Netherlands
- London School Of Hygiene And Tropical Medicine Royal Charter, London, United Kingdom
- Stichting Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
- Task Foundation Npc, Cape Town, South Africa
- The Regents Of The University Of California, Oakland Ca, United States
- The University Court Of The University Of St Andrews, St Andrews, Fife, United Kingdom
- The University Of Liverpool, Liverpool, United Kingdom
- Tuberculosis Network European Trialsgroup Ev, Bad Oldesloe, Germany
- Universita Degli Studi Di Milano, Milano, Italy
- Universita Vita-Salute San Raffaele, Milano, Italy
- University College London, London, United Kingdom
- University Of Hamburg, Hamburg, Germany
- University of Cambridge, Cambridge, United Kingdom
- University of Oxford, Oxford, United Kingdom
- Uppsala Universitet, Uppsala, Sweden
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Critical Path Institute, Limited, Dublin, Ireland
- Instituto De Saude Publica Da Universidade Do Porto, Porto, Portugal
- Stichting Lygature, Utrecht, Netherlands
Associated partners
- Deutsches Zentrum Fur Infektionsforschung (Dzif) Ev, Braunschweig, Germany
- Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany
Third parties
- Klinikum Der Universitat Munchen, Munchen, Germany
- Lungs Europe, Brussels, Belgium
| Participants | |
|---|---|
| Name | EU funding in € |
| Critical Path Institute, Limited | 2 387 091 |
| European Lung Foundation | 230 375 |
| European Respiratory Society | 223 375 |
| Forschungszentrum Borstel Leibniz Lungenzentrum | 3 567 835 |
| Foundation For Innovative New Diagnostics | 1 135 540 |
| Global Alliance For Tb Drug Development Non Profit Organisation | 1 393 765 |
| Helmholtz Zentrum Muenchen Deutsches Forschungszentrum Fuer Gesundheit Und Umwelt GMBH | 1 775 000 |
| Institut De Recherche Pour Le Developpement | 144 995 |
| Instituto De Saude Publica Da Universidade Do Porto | 616 040 |
| Koninklijke Nederlandse Centrale Vereniging Tot Bestrijding Der Tuberculose (Kncv) | 1 573 524 |
| London School Of Hygiene And Tropical Medicine Royal Charter | 794 948 |
| Stichting Lygature | 2 225 248 |
| Stichting Radboud Universitair Medisch Centrum | 58 035 625 |
| Task Foundation Npc | 683 425 |
| The Regents Of The University Of California | 1 500 100 |
| The University Court Of The University Of St Andrews | 682 874 |
| The University Of Liverpool | 1 630 443 |
| Tuberculosis Network European Trialsgroup Ev | 250 438 |
| Universita Degli Studi Di Milano | 402 653 |
| Universita Vita-Salute San Raffaele | 788 000 |
| University College London | 9 333 906 |
| University of Cambridge | 241 930 |
| University Of Hamburg | 436 250 |
| University Of Lancaster (left the project) | 11 418 |
| University of Oxford | 1 510 819 |
| Uppsala Universitet | 884 388 |
| Third parties | |
| Name | Funding in € |
| Lungs Europe | 40 000 |
| Total Cost | 92 500 005 |
Derek Sloan
Stichting Radboud Universitair Medisch Centrum