European Regimen Accelerator for Tuberculosis

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Acronym ERA4TB
Grant Agreement No 853989
Programme H2020-EU.3.1.7. – Innovative Medicines Initiative 2 (IMI2)
Call reference H2020-JTI-IMI2-2018-15-two-stage
Implementation period 01.01.2020 31.12.2025
WEB page https://era4tb.org/
Project coordinator University Carlos III de Madrid
Project participants Academic institutions:
University of Zaragoza
Uppsala University
École polytechnique fédérale de Lausanne
University of Köln
University of Padova
University of Pavia
Lund University

Non-profit organizations:
Institute Pasteur (Paris)
Institute Pasteur de Lille Foundation
Foundation Innovative Medicines for Tuberculosis
Bioaster Foundation de Coopération Scientifique

Public research organizations:
Latvia Institute of Organic Synthesis (LIOS)
Forschungszentrum Borstel
Consiglio Nazionale delle Richerche
Infectious Diseases Models for Innovative Therapies
Instituto de Investigación Hospital Universitario La Paz
Public Health England- Department of Health
The National Institute for Health and Care Excellence
Sciensano

Highly skilled small-medium enterprises:
Synapse Research Management Partners
Critical Path Institute, Limited
ImaBiotech
QPS Netherlands BV
GRIT42 Scientific Data Insights

EFPIA members:
Glaxosmithkline Investigacion y Desarrollo SL
Evotec International GmbH
Janssen Pharmaceutica NV

IMI2 Associated Partners:
Bill & Melinda Gates Foundation
TB Alliance
University of Dundee

Leader of LIOS team Professor Aigars Jirgensons
Total Budget € 207 963 991
EU contribution € 89 815 600

The European Regimen Accelerator for Tuberculosis (ERA4TB) has the explicit goal of developing a new combination therapy to treat all forms of TB starting from ~20 leads and drug candidates provided by EFPIA. Since details of these are as yet unavailable, we will implement an agile drug development algorithm that entails profiling and portfolio construction. Profiling involves characterisation and ranking molecules in preclinical studies comprising in vitro drug combination assays, hollow fiber and single cell analysis, innovative murine and non-human primate models, PK/PD studies, combined with biomarker discovery and non-invasive NIR or PET/CT imaging to monitor disease progression and response to treatment.

Modelling, simulation and artificial intelligence tools will help progress compounds from early preclinical to clinical development and to predict drug exposure, human doses and the best combinations. After extensive preclinical profiling, selected compounds will enter portfolio development for the first time in human tests and phase I clinical trials in order to ensure that they are safe, well-tolerated and bioavailable with negligible drug-drug interactions. If needed, formulation studies will be conducted to improve pharmacological properties.

ERA4TB has assembled the best expertise and resources available in Europe, to build a highly effective and sustainable drug development consortium with a flexible and dynamic management system to execute the profiling and portfolio strategy, aided by clearly defined go/no-go decision points. The expected outcome of ERA4TB is a series of highly active, bactericidal, orally available drugs to constitute two or more new combination regimens with treatment-shortening potential ready for Phase II clinical evaluation. These regimens will be compatible with drugs used to treat common comorbidities, such as HIV-AIDS and diabetes, and should impact UN Sustainable Development Goal 3, namely, ending TB by 2030.