Lancaster University researchers are working as part of a major international programme that aims to develop new, safe and affordable treatments for TB.

Involving a new consortium of 30 partners from 13 countries the seven-year, €185 million project called UNITE4TB, aims to accelerate and improve the clinical evaluation of novel compounds and combinations of drugs, with the goal of developing new and highly active anti-TB treatment regimens for drug-resistant and drug-sensitive TB.

UNITE4TB is the newest project of the IMI AMR Accelerator, a public-private collaboration with the shared goal of progressing the development of new medicines to treat or prevent resistant bacterial infections.

“Tuberculosis is a major threat to public health worldwide. By bringing together leading experts from the public and private sectors in Europe and beyond, UNITE4TB is well placed to deliver results that will accelerate the development of better treatment regimens to tackle this disease,” says Dr Pierre Meulien, Executive Director ofInnovative Medicines Initiative (IMI), a public-private European Research & Development Consortium.

Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). The growing emergence of multidrug-resistant TB is well-recognised as a public health challenge and has sparked new interest and investment in anti-TB drug development. Despite increased activity in the field, an integrated approach to TB drug development is still limited.

With European Federation of Pharmaceutical Industries and Associations (EFPIA) and Associated Partners on board, UNITE4TB has access to the majority of the most innovative TB compounds, currently in late pre-clinical, clinical phase 1, and early phase 2 stage. The consortium will deliver an efficient, global clinical trials network equipped to conduct phase 2 trials. State-of-the-art adaptive trial designs will be implemented, and advanced modelling, artificial intelligence and machine learning techniques will be employed. All of this will allow for the selection and testing of novel combination regimens with a high probability of success in subsequent phase 3 clinical trials.

Anja Karliczek, Germany’s Federal Minister of Education and Research, says: “Europe’s UNITE4TB project creates an important new platform for research to combat tuberculosis. Science and industry will jointly test their clinical candidates and share research results. The objective is to develop effective combinations for new, urgently needed solutions to treat tuberculosis. This public-private partnership will set a new standard in the fight against global diseases such as TB. UNITE4TB is a remarkable example of international research collaboration. I am delighted that Germany is supporting the consortium with funding of around 25 million euros to the two German Associated Partners. I am confident that UNITE4TB will contribute towards achieving the goal of ending tuberculosis by 2030 that was adopted by the G20 Heads of State and Government at the UN General Assembly.”

Researchers at Lancaster University are co-leading the work on developing novel designs for phase 2A clinical trials for new TB drugs. In addition to designing new clinical trials the Lancaster University team will also lead on the computer simulations that will help evaluate these designs.

Thomas Jaki, Professor in Statistics at Lancaster University, said: “The close collaborations between drug developers, methodologists, trialists and others in this project will shape the treatment of TB in the future and reduce the burden on patients. I am excited about the key role statistical thinking and trial design plays in this collaboration and am convinced that learnings from UNITE4TB will influence many other diseases as well."

UNITE4TB is the largest public-private collaboration on clinical TB drug development in the history of the EU. It will set a new standard for anti-TB regimen development, enhancing the efficiency with which new treatments are delivered to TB patients across the world.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.

The Lancaster University researchers working as part of UNITE4TB include Professor Thomas Jaki and Dr Pavel Mozgunov.