Running clinical trials of new TB treatment combinations takes a long time. New IMI project UNITE4TB wants to speed things up.
Tuberculosis (TB) kills around 1.5 million people annually, making it one of the leading causes of death worldwide. Treatment consists of a combination of drugs taken for at least six months, or even longer in patients whose disease is resistant to frontline treatments. The long treatment time, coupled with the side effects of some drugs, leads some patients to stop taking their antibiotics, and this contributes to drug resistance, which is on the rise. However, identifying new treatments and treatment combinations that could shorten the treatment time and tackle drug resistance is difficult and time-consuming.
Now IMI has launched a new project, UNITE4TB, which aims to accelerate and improve clinical trials of combinations of existing and new drugs, with the goal of developing new and highly active treatment regimens for TB, including drug-resistant TB.
Between them, the partners have access to the majority of the most innovative anti-TB drugs that are at an advanced stage of development. The project will focus on phase 2 clinical trials, in which drugs are tested in patients with a view to gathering data on the drugs’ safety and efficacy as well as the best dosage and delivery method (e.g. tablet or injection).
The project aims to develop a new approach to trialling TB drugs in phase 2 clinical trials. They will first use simulation tools to identify the optimal doses for each drug, then run a multi-arm, adaptive clinical trial of the best candidate regimens. The advantage of an adaptive trial is that many treatment regimens can be evaluated simultaneously, dramatically speeding up the trial process. To further speed up the process, the project will draw on existing global TB clinical trial networks with the capacity to rapidly enrol patients across four continents.
Using this approach, the project hopes to identify promising TB treatment regimens that could be further tested in phase 3 clinical trials, which typically involve a much larger number of patients than phase 2 trials.
The hope is that these regimens could ultimately become the global gold-standard for TB treatment, and so contribute to the goals of the World Health Organization’s End TB programme.
‘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 of IMI.
UNITE4TB will run for 7 years and has a total budget of EUR 185 million. Half of this comes from IMI and funds the involvement in UNITE4TB of partners such as universities and small and medium-sized enterprises (SMEs). The other half comes from the large pharmaceutical companies and the IMI2 Associated Partners. The project is part of IMI’s AMR Accelerator programme.