AMR – a global public health emergency
Antimicrobial resistance is a major threat to public health worldwide. In Europe alone, AMR kills an estimated 33 000 people annually. Globally, it kills 700 000 every year and that figure is set to rise to 10 million by 2050. There is therefore an urgent need for new medicines to prevent and treat resistant infections. In its 2017 action plan on AMR, the European Commission includes a chapter dedicated to boosting research, development and innovation which cites IMI as one of the tools to be used to address AMR.
Introducing the IMI AMR Accelerator
IMI launched the AMR Accelerator in 2018 as part of IMI2 – Calls 15 and 16; two additional AMR Accelerator topics were launched in 2020 as part of IMI2 - Call 20 and IMI2 - Call 23. The goal of the programme is to progress the development of new medicines to treat or even prevent resistant bacterial infections in Europe and worldwide. The programme has three pillars: a Capability Building Network, a Tuberculosis Drug Development Network; and Portfolio Building Networks. The scope of the AMR Accelerator is broad; under one structure, it addresses many of the scientific challenges of AMR, and it supports the development of new ways to prevent and treat AMR (including new antibiotics).
Within this broad scope, projects in the AMR Accelerator will develop new pre-clinical tools and methods, validate alternative or ‘non-traditional’ approaches, progress potential new treatments through phase 1-3 clinical trials, and analyse data from EFPIA-funded clinical trials to assist in the translation of preclinical data to clinical results of novel anti-infective agents. As such, the AMR Accelerator complements and builds on the achievements of IMI’s New Drugs for Bad Bugs programme, which also focuses on AMR.
Pillar A: Capability Building Network (CBN) to accelerate and validate scientific discoveries
The Capability Building Network comprises one project, COMBINE, which was created to coordinate the AMR Accelerator projects and provide them with the resources they need to achieve their goals. These include data management guidelines and an IT infrastructure to enable the collection, aggregation, storage, sharing and analysis of datasets generated by AMR Accelerator projects. COMBINE will also help to ensure that data adheres to ‘FAIR’ principles, i.e. it is findable, accessible, interoperable, and re-useable. Promoting communication among the projects is another COMBINE priority.
On the scientific front, COMBINE aims to improve the animal models used in AMR research and develop improved tools to reliably translate results in animals into results in humans. The project also aims to optimise the design and analysis of clinical trials. These tools will help all projects in the programme to deliver results that will help to accelerate the development of novel antibiotics and vaccines against AMR.
A second topic under Pillar A was launched in June 2020 as part of IMI2 - Call 23. The goal of this topic is to develop a mathematical model capable of realistically assessing which vaccines and monoclonal antibodies (mAbs) have the best chance of reducing AMR and the associated health and economic impacts. The model will take into account the concerns of different stakeholders (e.g. the industry and public health bodies), and will be made publicly accessible.
- COMBINE | Collaboration for prevention and treatment of MDR [multi-drug resistant] bacterial infections
Pillar B: Tuberculosis Drug Development Network (TBDDN) to accelerate and validate scientific discoveries and advance the R&D pipeline of new and innovative agents to address the global TB epidemic
As its name suggests, the Tuberculosis Drug Development Network is working to accelerate the discovery of new combinations of drugs to treat TB. Treating TB involves regimens of a number of drugs, and as new drugs are added to regimens one by one, building a new, faster and safer treatment regimen takes a very long time. The ERA4TB project 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. Concretely, the project aims to create 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.
IMI2 - Call 20, launched in January 2020, includes a topic that will result in a second project under the TBDDN. The goal of this topic is to develop and carry out innovative clinical trial designs to identify new treatment combinations using drugs that have already undergone initial studies in humans. The topic will also develop and evaluate new technologies to monitor and enhance treatment adherence.
- ERA4TB | European regimen accelerator for tuberculosis
Pillar C: Portfolio Building Networks (PBN) to advance the R&D pipeline of new and innovative agents to address AMR
The Portfolio Building Networks support collaborative efforts to discover, develop and advance new and innovative agents to prevent or treat AMR. PBNs provide a mechanism for dedicated partnerships between EFPIA companies and small and medium-sized enterprises (SMEs) and/or academic teams for the discovery and development of new antibacterial assets. Assets and projects can originate from SMEs, academia, or EFPIA companies, and will be jointly progressed or studied, including both pre-clinical work and potentially phase 1-3 clinical development.
- AB-DIRECT | Antibiotic distribution and recovery in tissue
- GNA NOW | Novel Gram-negative antibiotic now
- RespiriNTM | Progress novel assets (one FIH [first in human] start) for non-tubercular mycobacteria that may act synergistically with bedaquiline and cytochrome bc drugs
- RespiriTB | Progress new assets (one pre-new molecular entity and one first-time-in-human start) for tuberculosis that act synergistically with bedaquiline, cytochrome bc or cytochrome bd inhibitors
- TRIC-TB | Boosting ethionamide efficacy and lowering the dose with a small molecule transcriptional modulators, to overcoming MDR-TB [multi-drug resistant tuberculosis] infections and define a new place for ethionamide in 1st-line TB treatments