Acronym | ETA4TB |
|---|---|
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 |
website | 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, Institute Pasteur de Lille Foundation, Foundation Innovative Medicines for Tuberculosis, Bioaster Foundation de Coopération Scientifique |
Public research organizations | Latvian 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, 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 the LIOS team | Professor Aigars Jirgensons |
Total Budget | € 207 963 991 |
EU contribution | € 89 815 600 |
Project leaders from LIOS | Prof. Aigars Jirgensons |
Prof. Raivis Žalubovskis |
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.