"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."
LMU University Hospital Munich is the sponsor of DECISION (BTZ-043 Dose Evaluationin CombInationand 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.
