UNITE4TB - Recruitment for DECISION Trial

“We are thrilled to have completed recruitment for the DECISION trial,” said Prof. Michael Hoelscher, Director of the Institute of Infectious Diseases and Tropical Medicine (LMU) and Head of the Unit Global Health (Helmholtz 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.”

LMU University Hospital Munich is the sponsor of DECISION (BTZ-043 Dose Evaluation in CombInation and SelectION), with the trial coordinated and overseen by the Tropical Institute. DECISION is a phase-IIb, dose-finding study comparing the safety and efficacy of different doses of BTZ-043 in participants with drug-sensitive tuberculosis.

BTZ-043, developed jointly by the Leibniz-HKI (Leibniz Institute for Natural Product Research and Infection Biology) in Jena and LMU University Hospital Munich, represents a breakthrough in TB treatment. This novel antibiotic, recently named the Leibniz pharmaceutical substance of the Year 2023, exhibits a unique mechanism of action and has shown efficacy against drug-resistant strains of Mycobacterium tuberculosis, making it a promising candidate to enhance TB treatment globally.

The DECISION trial is one of two trials in UNITE4TB aiming to revolutionize tuberculosis treatment by optimizing 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 the MRC Clinical Trials Unit at UCL in London, evaluates multiple treatment regimens and durations for tuberculosis, focusing on optimizing combinations involving novel drugs like BTZ-043 and GSK656 alongside established therapies such as Bedaquiline and Delamanid. 

BTZ053 - the first antibiotic to be developed in Germany in decades

Discovered by researchers at the Leibniz Institute for Natural Product Research and Infection Biology (Leibniz-HKI) in Jena, BTZ-043 inhibits an enzyme in tuberculosis pathogens essential for building the bacterial cell wall, causing the cell 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.

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.

For more information about the DECISION trial and the UNITE4TB initiative, please visit the website.