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News | 08/01/2025

Tuberculosis research: New effective active substance with great potential

The effectiveness of the new antibiotic has been demonstrated by researchers at the Tropical Institute of the LMU Hospital, among others.
Tuberculosis is the most common infectious disease worldwide. In 2023 alone, there were 10.6 million new infections and 1.3 million deaths. "There is an urgent need for new effective drugs to combat tuberculosis, especially due to the growing problem of antibiotic-resistant strains," says Scientific Program Manager Dr. med. vet. Julia Dreisbach, who is driving the development of new active substances together with Institute Director Prof. Michael Hoelscher.
LMU Klinikum

The European-African network PanACEA - a consortium of tuberculosis researchers from five European and eleven African institutions - has now published study results in the journal The Lancet Microbe that show the promising potential of a novel antibiotic. The active substance BTZ-043 was discovered by the Leibniz Institute for Natural Product Research and Infection Biology - Hans Knöll Institute - (Leibniz-HKI) in Jena and then further developed preclinically and clinically in a collaboration with the Tropical Institute of the LMU Klinikum and the German Center for Infection Research (DZIF). If further clinical trials are successful, it could play a key role in the global fight against tuberculosis.

The safety and tolerability of the drug were investigated in 77 adults with newly diagnosed pulmonary tuberculosis in Cape Town, South Africa. "The study proves that BTZ-043 is antibacterially effective and well tolerated and can also be administered in combination with other tuberculosis drugs," says PD Dr. Norbert Heinrich, Senior Physician and Scientific Lead Tuberculosis, summarizing the results. BTZ-043 is the first antibiotic candidate to be developed exclusively by the academic community. Discovered by researchers at the Leibniz-HKI in Jena and developed in a collaboration between the LMU Klinikum and the Leibniz-HKI, the active substance inhibits an enzyme that tuberculosis pathogens need to build their cell wall, causing them to disintegrate and die.

The PanACEA study is one of the first adaptive model-based dose-finding studies for a tuberculosis drug and the first of its kind to be conducted in Africa. "The innovative design of the study, including assessments of dietary effects and drug-drug interactions, now gives us a comprehensive understanding of how BTZ-043 can be optimally administered," said Dr. Heinrich.


Original publication:

N. Heinrich et al: Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043-02): an open-label, dose-expansion, randomized, controlled, phase 1b/2a trial. The Lancet Microbe 2025

This study is part of the EDCTP2 program (grant TRIA2015-1102) and is funded by the German Federal Ministry of Education and Research (01KA1701), the German Center for Infection Research, InfectControl (03ZZ0803A, 03ZZ0835A and 03ZZ0826A), the Bavarian State Ministry of Science and the Arts, the Swiss State Secretariat for Education, Research and Innovation and the Netherlands Organization for Scientific Research (Nederlandse Organisatie voor Wetenschappelijk Onderzoek).

Originally translated with DeepL