AMR Accelerator programme Pillar B: Tuberculosis drug development network to accelerate and validate scientific discoveries and advance the R&D pipeline of new and innovative agents to address the global tuberculosis epidemic

Topic description

Specific Challenge:

There are significant scientific challenges to the discovery and development of new agents to treat and prevent AMR infections, including those caused by Gram-positive and Gram-negative bacteria, Mycobacterium tuberculosis, and non-tubercular mycobacteria (NTM). The AMR Accelerator will provide, under one operational structure, a wide-ranging series of projects that will address many of the scientific challenges in AMR.

TB is the leading cause of death from a single infectious agent worldwide. The lack of efficiency of current TB drugs is emphasised by the nearly 1.8 million annual deaths reported by World Health Organisation (WHO). Of these, 200 000 were confirmed cases of drug resistant TB, although real estimates could be much higher. As expressed by the United Nations (UN), a massive scale-up and a dynamic, global, multi-sectoral approach is needed if the global target of eradicating tuberculosis by 2030 is to be met. At present, there is a strong consensus both in private and public research sectors working on TB that having a large number of new drug candidates, which are ready to enter into clinical combination studies, is the most critical step to achieving this aspirational goal that will have a tremendous impact on global health.

The TB drug development Network (TBDDN), pillar B of the IMI2 AMR Accelerator programme, will function as a platform based on the principles of open innovation to advance discovery, preclinical and early clinical projects in the field of TB and MDR-TB. One of the objectives of the TBDDN is to become a worldwide reference for the development of novel candidates and regimens by sharing results generated by partners and peers from small and medium-sized enterprises (SMEs), public institutions and pharmaceutical companies

Specifically, the scope of this action is to: (1) coordinate, profile and progress the portfolio of anti-TB compounds existing within the industry consortium (EFPIA companies and Associated Partners) from the advanced lead stage through Phase 1 (candidates ready to enter into Ph-2 clinical studies); (2) identify preferred drug partners for preclinical combination studies that will facilitate the design of combination regimens consisting of new TB drugs with an indication for the treatment of any form, including MDR, of TB (pan-TB regimen); (3) create additional tools and technologies to progress anti-TB compounds, and to provide learnings derived from the analysis of shared anti-TB clinical trial data; (4) develop new alternative anti-tubercular drugs (host-defence or virulence approaches); (5) act as an interface with stakeholders in the TB field and explore synergies and collaboration with the action resulting from IMI2 JU Call 15, topic 7 and potential TB-focused actions from IMI2 JU Call 16 as well as other AMR initiatives.

The impact of the TBDDN will help attain the UN 2030 objective by: (1) providing new tools and understandings to progress TB science for the discovery of new preclinical candidates and novel combination regimens across the TB R&D landscape; (2) contributing to the development of a vibrant TB research environment in the EU and strengthening the competitiveness and industrial leadership of Europe; (3) contributing to EU’s ambition of being a ‘best practice region’ for addressing AMR; (4) enabling the progression of potential new treatment solutions for TB patients worldwide using a preferential pricing approach for low- and middle-income countries, with the intent to improve the quality of life and life expectation of TB patients; (5) strengthening interaction of TB R&D stakeholders from across the EU and globally.