ERA4TB

IMI has launched two separate projects that, when combined, represent the biggest effort to combat tuberculosis (TB) in history.###

UNITE4TB, launched in 2021, is the first and only initiative of its kind in the world. The project is building a platform for carrying out clinical trials of new drug combinations for TB. They will focus on phase 2 and 'phase 3-ready' clinical trials. The partners have access to the majority of the most innovative anti-TB drugs at an advanced stage of development and will jointly test their clinical candidates and share research results.

ERA4TB, launched in 2020, has a budget of €208 million and 31 partners, and is focusing on pre-clinical development of combination therapies from pre-clinical to phase 1-ready.

The methodology for both projects is the same. They are investigating the possibility of testing TB drugs in parallel as opposed to sequentially – the ‘racetrack’ concept – an approach that will help test the safety and efficacy of drug combinations of over a dozen drug candidates at the same time.

Both projects combined bring the total investment to almost €400 million. The hope is that these efforts will produce TB treatment regimens that could ultimately become the global gold standard.

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IMI Associated Partner TB Alliance is a non-profit organisation whose mission is the discovery, development and delivery of new and affordable tuberculosis (TB) drugs. In an interview with the IMI Programme Office, Director of External Affairs Ana Maria Harkins says that the partnership with IMI allows them to expand funding beyond a small and mostly static group of donors.###

‘As a product development partnership, we leverage public-private mechanisms to accomplish our work, and the IMI model aligns well with our way of working,’ says Ms Harkin. ‘IMI brings together many of the main players and we greatly value the resources it makes available, as well as a platform to collaborate with industry, academia and the public sector.’

TB Alliance is involved in two IMI projects. Through ERA4TB, they are contributing two compounds for development, one of which is in Phase 1 trial. In EU-PEARL, they are involved in the work package dedicated to TB, where they provide regulatory expertise, knowledge and tools for community and patient engagement.

Asked about the benefits of working in a public-private partnership, Ms Harkin highlights the importance of tackling market failures like antimicrobial resistance. ‘Without political and financial incentives, the industry has little incentive to develop antibiotics,’ she says. ‘IMI provides resources to incentivise drug development, and an architecture that brings together an array of partners to contribute compounds, perform preclinical and clinical work, exchange data and research learnings and jointly work towards a set of agreed-upon outcomes.’

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