ERA4TB

European regimen accelerator for tuberculosis

Summary

Tuberculosis (TB) poses a serious threat to public health worldwide; in 2018 alone, an estimated 10 million people fell ill with the disease and 1.6 million died. The goal of the ERA4TB project is to accelerate the development of a new, more efficient treatment regimen that will help the world to meet the United Nations goal of ending the TB epidemic by 2030.

Today, standard TB treatment consists of a regimen of four drugs and lasts at least six months; for people with drug-resistant TB, treatment lasts even longer. New drugs are added to regimens one by one, meaning that building a new, faster and safer treatment regimen takes a very long time.

ERA4TB plans to drop the sequential approach and instead adopt a parallel pathway, which will allow the project to investigate the safety and efficacy of combinations of over a dozen drug candidates at the same time. By using a standardised approach and studying multiple molecules in parallel, the project hopes to optimise and speed up the development of new drug regimens needed to stop TB in its tracks.

The project will achieve this by creating a world-class ‘platform’ that brings together the expertise, tools and resources needed to accelerate the development of anti-TB drug combinations. The hope is that the platform will continue to operate beyond the end of the project.

ERA4TB 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.

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‘The IMI model aligns with our way of working’ – IMI Associated Partner TB Alliance

IMI Associated Partner TB Alliance is a non-profit organisation whose mission is the discovery, development and delivery of new and affordable tuberculosis (TB) drugs. In an interview with the IMI Programme Office, Director of External Affairs Ana Maria Harkins says that the partnership with IMI allows them to expand funding beyond a small and mostly static group of donors.###

‘As a product development partnership, we leverage public-private mechanisms to accomplish our work, and the IMI model aligns well with our way of working,’ says Ms Harkin. ‘IMI brings together many of the main players and we greatly value the resources it makes available, as well as a platform to collaborate with industry, academia and the public sector.’

TB Alliance is involved in two IMI projects. Through ERA4TB, they are contributing two compounds for development, one of which is in Phase 1 trial. In EU-PEARL, they are involved in the work package dedicated to TB, where they provide regulatory expertise, knowledge and tools for community and patient engagement.

Asked about the benefits of working in a public-private partnership, Ms Harkin highlights the importance of tackling market failures like antimicrobial resistance. ‘Without political and financial incentives, the industry has little incentive to develop antibiotics,’ she says. ‘IMI provides resources to incentivise drug development, and an architecture that brings together an array of partners to contribute compounds, perform preclinical and clinical work, exchange data and research learnings and jointly work towards a set of agreed-upon outcomes.’

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Participants

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EFPIA companies
  • Evotec International GMBH, Hamburg, Germany
  • Glaxosmithkline Investigacion Y Desarrollo SL, Tres Cantos, Spain
  • Janssen Pharmaceutica Nv, Beerse, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Bioaster Fondation De Cooperation Scientifique, Lyon, France
  • Commissariat A L Energie Atomique Et Aux Energies Alternatives, Paris, France
  • Consiglio Nazionale Delle Ricerche, Roma, Italy
  • Department of Health, Leeds, United Kingdom
  • Ecole Polytechnique Federale De Lausanne, Lausanne, Switzerland
  • Fondation Innovative Medicines For Tuberculosis (Im4tb), Lausanne, Switzerland
  • Forschungszentrum Borstel, Borstel, Germany
  • Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau Fundacion, Barcelona, Spain
  • Institut Pasteur, Paris, France
  • Institut Pasteur De Lille Fondation, Lille, France
  • Klinikum Der Universitaet Zu Koeln, Cologne, Germany
  • Latvijas Organiskas Sintezes Instituts, Riga, Latvia
  • National Institute For Health And Care Excellence, Manchester, United Kingdom
  • Sciensano, Brussels, Belgium
  • Servicio Madrileno De Salud, Madrid, Spain
  • Universidad Carlos Iii De Madrid, Getafe (Madrid), Spain
  • Universidad De Zaragoza, Zaragoza, Spain
  • Universita Degli Studi Di Padova, Padova, Italy
  • Universita Degli Studi Di Pavia, Pavia, Italy
  • Uppsala Universitet, Uppsala, Sweden
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Critical Path Institute, Limited, Dublin, Ireland
  • Gritsystems As, Dragør, Denmark
  • Imabiotech SAS, Loos, France
  • Qps Netherlands BV, Groningen, Netherlands
  • Synapse Research Management Partners SL, Barcelona, Spain
Associated partners
  • Bill & Melinda Gates Foundation, Seattle, United States
  • Global Alliance For Tb Drug Development Non Profit Organisation, New York, United States
  • University Of Dundee, Dundee, United Kingdom
Third parties
  • Fundacion Para La Investigacion Biomedica Del Hospital Universiatrio La Paz, Madrid, Spain

Participants
NameIHI funding in €
Bioaster Fondation De Cooperation Scientifique1 856 250
Commissariat A L Energie Atomique Et Aux Energies Alternatives2 476 939
Consiglio Nazionale Delle Ricerche2 443 750
Critical Path Institute, Limited3 557 500
Department of Health2 256 827
Ecole Polytechnique Federale De Lausanne962 500
Fondation Innovative Medicines For Tuberculosis (Im4tb)22 172 675
Forschungszentrum Borstel2 287 500
Gritsystems As1 132 500
Imabiotech SAS837 500
Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau Fundacion277 500
Institut Pasteur10 952 522
Institut Pasteur De Lille Fondation2 853 750
Klinikum Der Universitaet Zu Koeln1 407 500
Latvijas Organiskas Sintezes Instituts399 688
National Institute For Health And Care Excellence293 500
Qps Netherlands BV6 175 320
Sciensano1 637 500
Servicio Madrileno De Salud9 601 556
Synapse Research Management Partners SL2 397 359
Universidad Carlos Iii De Madrid5 084 941
Universidad De Zaragoza4 247 900
Universita Degli Studi Di Padova615 000
Universita Degli Studi Di Pavia592 000
Uppsala Universitet1 797 500
 
Third parties
NameFunding in €
Fundacion Para La Investigacion Biomedica Del Hospital Universiatrio La Paz1 498 125
 
Total Cost89 815 602