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UNITE4TB Completes Recruitment for DECISION Trial
We are proud to announce the successful completion of participant recruitment for the UNITE4TB DECISION trial. This achievement marks a pivotal milestone in our efforts to combat tuberculosis (TB) through innovative research and development.
DECISION (BTZ-043 Dose Evaluation in CombInation and SelectION), sponsored by consortium partner LMU University Hospital Munich, is one of two trials within UNITE4TB, alongside PARADIGM4TB, sponsored by MRC Clinical Trials Unit at UCL.
The phase 2B, dose-finding DECISION study compares the safety and efficacy of different doses of a novel antibiotic, BTZ-043, in 90 participants with drug-sensitive TB, recruited across four sites in South Africa and Tanzania. PARADIGM4TB, on the other hand, is evaluating multiple treatment regimens and durations for TB, focusing on optimizing combinations involving novel drugs like BTZ-043 and GSK656 alongside established therapies such as bedaquiline and delamanid. Ultimately, the UNITE4TB clinical trial program aims to revolutionize TB treatment by optimizing regimens for both drug-sensitive and multidrug-resistant TB.
“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 at LMU 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.”
A new class of anti-TB compounds
BTZ-043 is a novel antibiotic that has shown efficacy against drug-resistant strains of Mycobacterium tuberculosis, positioning it as a promising candidate to enhance TB treatment globally. It is the first antibiotic to be developed in Germany in decades. Discovered by researchers at Leibniz-HKI in the German city of Jena, BTZ-043 exhibits a unique mechanism of action, inhibiting an enzyme essential for building the bacterial cell wall in TB pathogens, causing the cells to dissolve and the pathogens to die. Since 2014, Leibniz-HKI and the Tropical Institute at LMU University Hospital Munich have collaborated on advancing the preclinical development of this novel compound.