Project description
Helping to end all forms of TB
In 2018 alone, about 10 million people became ill with tuberculosis (TB) globally and 1.5 million people died from it, placing this disease among the top 10 causes of death in the world. According to the WHO, about one fourth of the global population has been infected by Mycobacterium tuberculosis, although most infected individuals are asymptomatic. About 5-15 % of those infected develop tuberculosis and can transmit the disease. The standard TB treatment requires a 6-month course and involves the combination of several antimicrobial drugs, what makes the access and adherence to the treatment complicated. The TB epidemic has become even more serious with the rise of multidrug-resistant tuberculosis (MDR-TB) and the emergence of extensively drug-resistant TB (XDR-TB). Only half of the patients with MDR-TB are successfully treated, whereas those with XDR-TB type have few treatment options. The EU-funded project ERA4TB is accelerating development of highly active oral drugs with shortened treatment durations to help end all forms of TB by 2030.
Objective
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 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.
Fields of science
- natural sciencesbiological scienceszoologymammalogyprimatology
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- natural sciencescomputer and information sciencesartificial intelligence
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesclinical medicinepneumologytuberculosis
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
28903 Getafe (Madrid)
Spain
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Participants (32)
75724 Paris
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50009 Zaragoza
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59019 Lille
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28006 Madrid
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
23845 Borstel
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1015 Lausanne
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2 Dublin
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
00185 Roma
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75015 PARIS 15
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28046 MADRID
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
28046 Madrid
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751 05 Uppsala
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LS2 7UE Leeds
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1015 Lausanne
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50937 Koeln
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35122 Padova
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27100 Pavia
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M1 4BT Manchester
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59120 Loos
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1050 Elsene
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LV-1006 Riga
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69007 Lyon
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9713 GZ Groningen
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Participation ended
22100 Lund
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2500 Valby
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
28760 TRES CANTOS MADRID
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22419 Hamburg
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2340 Beerse
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98102 Seattle, Washington
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10005 NEW YORK
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DD1 4HN Dundee
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08041 Barcelona
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