UNITE4TB completes recruitment for DECISION trial
UNITE4TB—an international public-private partnership aiming to accelerate the development of innovative tuberculosis treatments—has announced the successful completion of participant recruitment for the UNITE4TB DECISION trial. This achievement marks a pivotal milestone in consortium’s efforts to combat tuberculosis through innovative research and development.
DECISION—short for “BTZ-043 Dose Evaluation in CombInation and SelectION”—is a phase IIb, dose-finding study. It aims to compare the safety and efficacy of different doses of a novel antibiotic, BTZ-043, in 90 participants with drug-sensitive tuberculosis (TB), recruited across four sites in South Africa and Tanzania. The study is sponsored by UNITE4TB’s partner LMU University Hospital Munich, with the trial coordinated and overseen by the Tropical Institute.
The DECISION trial is one of two trials in UNITE4TB aiming to revolutionise TB treatment by optimising regimens for both drug-sensitive and multidrug-resistant tuberculosis, addressing critical gaps in current treatment strategies with innovative approaches. The second trial in UNITE4TB, PARADIGM4TB—sponsored by MRC Clinical Trials Unit at UCL in London—evaluates multiple treatment regimens and durations for TB, focusing on optimising combinations involving novel drugs like BTZ-043 and GSK656 alongside established therapies such as bedaquiline and delamanid.
“We are thrilled to have completed recruitment for the DECISION trial,” says Prof. Michael Hoelscher, Director of the Institute of Infectious Diseases and Tropical Medicine at LMU University Hospital Munich. “This achievement underscores the dedication and hard work of our global UNITE4TB team and our local trial partners. The results of the DECISION trial will help to define the right dose of BTZ-0434 and thus contribute significantly to the global fight against tuberculosis.”
BTZ-043—the first antibiotic to be developed in Germany in decades
BTZ-043 has shown efficacy against drug-resistant strains of M. tuberculosis, making it a promising candidate to enhance TB treatment globally. Discovered by researchers at the Leibniz Institute for Natural Product Research and Infection Biology (Leibniz-HKI) in Jena, BTZ-043 exhibits a unique mechanism of action: it inhibits an enzyme in the tuberculosis pathogens essential for building the bacterial cell wall, causing the cells to dissolve and the pathogen to die. Since 2014, the Leibniz-HKI and the Tropical Institute at the LMU University Hospital Munich have collaborated on advancing the preclinical development of this novel compound, which has recently been named the Leibniz pharmaceutical substance of the year 2023.
By the time the second phase of clinical development is completed, the project will have cost about 60 million euros. The German Federal Ministry of Education and Research (BMBF) is providing around 50 percent of this funding either directly or through the German Center for Infection Research (DZIF). Further funding is provided by the European-African "European & Developing Countries Clinical Trials Partnership" (EDCTP), the European "Innovative Medicines Initiative" (IMI), the Bavarian State Ministry of Science and the Arts, and the Free State of Thuringia.
About UNITE4TB
UNITE4TB is an international research consortium focused on accelerating the development of new and effective treatments for tuberculosis. By harnessing the power of global partnerships, cutting-edge research and innovative clinical trials, UNITE4TB aims to reduce the burden of TB worldwide and improve the lives of those affected by this disease. The DZIF and the LMU University Hospital Munich, a member institution of the DZIF, play a central role in the UNITE4TB consortium.
For more information about the DECISION trial and the UNITE4TB initiative, please visit the website.
Source: Press release of LMU University Hospital Munich Tropical Institute.
