Science & Research

A new dawn in the fight against Tuberculosis: UNITE4TB starts phase two clinical trials

A new dawn in the fight against Tuberculosis: UNITE4TB starts phase two clinical trials - article image

8 November, 2023

Leading Tuberculosis (TB) drug developer, UNITE4TB, of which the European Respiratory Society (ERS) is a consortium member, has today announced the start of its Phase 2B/C clinical trial program, with the first participant enrolled at its trial site in Cape Town, South Africa.

This announcement is a major milestone for the TB community. TB is a major threat to public health, having killed 1.6 million people in 2021, making it the second leading infectious killer after COVID-19. The trial sites have been chosen based on TB prevalence, with additional sites in Tanzania, Uganda, Vietnam, and the Philippines.

Launched in July 2021, with funding from the Innovative Health Initiative (IHI), and the support of 30 partners, UNITE4TB is the largest public-private partnership on clinical TB drug development in the European Union. Two years on, the project continues to strive to advance TB science and enhance the efficiency with which new treatments are delivered.

UNITE4TB’s innovative Phase 2B/C trials will test 14 combinations of nine existing drugs, as well as two newly developed candidates. The aim is to create regimens that can further improve multidrug-resistant (MDR) treatment and be effective for drug-sensitive TB.

Prof. Martin Boeree, UNITE4TB project coordinator from Radboudumc said: “Today’s announcement marks an exciting moment for TB research. The world needs new drugs for TB but also new ways to run clinical studies. Our public-private partnership sets a new standard in this regard. If successful, our work will deliver a new treatment regimen that can be used to fight all types of tuberculosis.”

Prof. Raquel Duarte, Head of ERS Assembly 10: Respiratory infections added: “ERS is a proud partner of the UNITE4TB project. It is so important that developments of innovative tuberculosis treatments are fast tracked – we cannot ignore the impact TB is still having. These clinical trials embrace new diagnostic methods which are a game changer for how patients are monitored as part of the trial.”

For people affected by TB, the most important outcome is rapid access to better regimens with fewer side effects. Additionally, drug-resistant TB and long treatment regimens have increased the urgency for action and investment in TB research. UNITE4TB is engaging with key stakeholders to ensure that its novel regimens will be made widely accessible.

Prof. Michael Hoelscher of LMU University Hospital Munich said: “There are three major steps in TB regimen development: the establishment of the optimal dose for each individual drug, the identification of the right combination of four different drugs and the shortest possible treatment duration of the regimen of choice. In UNITE4TB, we are addressing these aspects via the most efficient trial designs possible.”

Find out more about UNITE4TB.

Access the recent ERS/UNITE4TB webinars on the ERS Respiratory Channel: