About
ERA4TB (European Accelerator of Tuberculosis Regime) project is a public-private initiative devoted to accelerate the development of new treatment regimens for tuberculosis.
PET/CT scan images from a healthy guinea pig (left), and from an infected guinea pig with chronic pulmonary inflammation (right). The image of the lung that was acquired using tomography can be seen in black and white, while the image in color shows the most active areas as detected by the PET scan, which correspond to the active inflammatory process.
ERA4TB is expected to revolutionize the way in which tuberculosis treatments are developed thanks to its parallelized, multi-entry pipeline structure, analogue to a production line. This structure will enable to systematically investigate the efficacy of several drug candidates and combinations simultaneously while allowing new molecules to enter the project pipeline at the research stage corresponding to the degree of knowledge on said candidate drugs gathered before the project.
With this approach, the ERA4TB consortium expects to reduce the time required for the development of new tuberculosis treatment regimens by up to a quarter.
The ERA4TB initiative integrates more than thirty organizations from the European Union and the United States among which are the main global actors in the fight against tuberculosis infection.
ERA4TB has started in 2020 and will last six years, at the end of which, the consortium expects to have developed at least two or more new combination regimens with treatment-shortening potential ready for Phase II clinical evaluation. The partners intend to maintain the ERA4TB platform active beyond the project official duration.
Objectives
The main objective of ERA4TB is to create a European open platform to accelerate the development of new regimens for the treatment of tuberculosis.
The main objective of ERA4TB is to create a European open platform to accelerate the development of new regimens for the treatment of tuberculosis. To reach this goal, the consortium has set the following specific objectives.
Implementation of state-of-the-art tools and capacities into an open platform for the evaluation of TB drug candidates to effectively progress compounds from early preclinical to clinical development and identify potential new Pan-tuberculosis (Pan-TB)1 regimens ready for Phase II clinical evaluation.
Development of modelling and simulation tools and application of standard and new artificial intelligence (AI) techniques for better characterization of pharmacokinetic-pharmacodynamic (PK/PD) relationships (concentration-effect or exposure-response relationships depending on the trial), optimization of clinical trial design, prediction of therapeutic dose range and antibacterial activity in humans.
Management of data generated by the project, integrating also data and knowledge from historical datasets available in reference databases and from previous and existing consortia and projects, in the context of an ever-improving ‘learning system’ that allows to refine the platform continuously.
Provision of a flexible and efficient management structure able to adapt the capacity and resource allocation level required by each platform component at each stage of the project, depending on each compound’s progression and attrition dynamics and on inherent variables of the multiple combination assays.
Provide a sustainability plan that incorporates all the synergies and lessons learned within the project and secures the survival of the platform beyond the life of the project.
Define and execute an outreach, engagement, dissemination and communication plan in collaboration with regulatory authorities and other stakeholders, including patient organizations, to maximize the impact of the project.
Ambition
All Member States of WHO and the UN have committed to the goal of ending the TB epidemic by 2030 through their unanimous endorsement of the WHO End TB Strategy at the World Health Assembly and their adoption of the UN Sustainable Development Goals (SDGs).
The commitment of the European Commission and the private sector (through the EFPIA companies), with the support of Associated Partners as key players in TB research, as well as other public and private research institutions in the EU to respond to this global challenge is materialised through the ERA4TB Consortium.
ERA4TB aims to build across Europe and consolidate globally a solid network of collaborations with the ambition of creating a novel world-class platform for the effective acceleration of new anti-TB drugs and regimens. This new platform, that intends to operate beyond the life of this project, will integrate, maintain and further advance the drug development processes and tools (including cutting edge solutions such as hollow fibre systems, single cell time-lapse analysis, imaging in animal models, new biomarkers and host/pathogen interactions and virulence approaches, drug-disease modelling, physiologically-based predictive modelling, artificial intelligence data mining and clinical trial simulation techniques) needed for the effective acceleration of anti-TB drug combinations.
The open philosophy of the platform, both in terms of capacity (by enabling participation of all relevant research groups and actors) and tools (by designing a pipeline that allows the ‘plugging-in’ of new promising techniques and assays as they become available) is expected to underpin long-term sustainability and position ERA4TB as a truly unique programme that leverages the best available knowledge and expertise in Europe. Here, we are inspired by precedents in other scientific areas, such as the CERN in physics, where a vibrant and competitive European community has been created and consolidated with excellent metrics in terms of performance and sustainability.
Structure
The ERA4TB platform is based on a progression pipeline that can cater for a variety of molecules at different stages of development.
ERA4TB aims to build across Europe and consolidate globally a solid network of collaborations with the ambition of creating a novel world-class platform for the effective acceleration of new anti-TB drugs and regimens. This new platform, that intends to operate beyond the life of this project, will integrate, maintain and further advance the drug development processes and tools (including cutting edge solutions such as hollow fibre systems, single cell time-lapse analysis, imaging in animal models, new biomarkers and host/pathogen interactions and virulence approaches, drug-disease modelling, physiologically-based predictive modelling, artificial intelligence data mining and clinical trial simulation techniques) needed for the effective acceleration of anti-TB drug combinations.
