UNITE4TB

Academia and industry united innovation and treatment for tuberculosis

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.

 

Achievements & News

Tuberculosis projects represent the biggest ever funding effort to combat the disease

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.

Find out more

 

Participants

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EFPIA 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, 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
  • Universitaet Hamburg, Hamburg, Germany
  • University College London, London, United Kingdom
  • University Of Lancaster, Lancaster, 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
NameIHI funding in €
Critical Path Institute, Limited2 387 091
European Lung Foundation230 375
European Respiratory Society223 375
Forschungszentrum Borstel3 312 103
Foundation For Innovative New Diagnostics1 135 540
Global Alliance For Tb Drug Development Non Profit Organisation1 393 765
Helmholtz Zentrum Muenchen Deutsches Forschungszentrum Fuer Gesundheit Und Umwelt GMBH1 775 000
Institut De Recherche Pour Le Developpement144 995
Instituto De Saude Publica Da Universidade Do Porto616 040
Koninklijke Nederlandse Centrale Vereniging Tot Bestrijding Der Tuberculose (Kncv)1 573 524
London School Of Hygiene And Tropical Medicine Royal Charter794 948
Stichting Lygature2 274 498
Stichting Radboud Universitair Medisch Centrum64 968 757
Task Foundation Npc869 670
The Regents Of The University Of California1 500 100
The University Court Of The University Of St Andrews633 985
The University Of Liverpool1 630 443
Tuberculosis Network European Trialsgroup Ev250 438
Universita Degli Studi Di Milano402 653
Universita Vita-Salute San Raffaele713 000
Universitaet Hamburg436 250
University College London2 994 251
University Of Lancaster253 348
University of Oxford1 499 569
Uppsala Universitet446 286
 
Third parties
NameFunding in €
Lungs Europe40 000
 
Total Cost92 500 004