Tuberculosis research: New effective active ingredient with great potential

Tuberculosis is the most common infectious disease worldwide. In 2022 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 BTZ-043 together with Professor Michael Hoelscher, Director of the Institute of Infectious Diseases and Tropical Medicine at LMU.

The European-African network PanACEA - a consortium of tuberculosis researchers from five European and eleven African institutions - has now published study results in the specialist journal The Lancet Microbe that show the promising potential of a new type of antibiotic. The active ingredient BTZ-043 was co-developed by the Tropical Institute of the LMU Klinikum and could play a key role in the global fight against tuberculosis.

The safety and tolerability of the preparation 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 ingredient 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," says Heinrich.

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, randomised, controlled, phase 1b/2a trial. The Lancet Microbe 2025