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Römpp, A.* ; Treu, A.* ; Kokesch-Himmelreich, J.* ; Marwitz, F.* ; Dreisbach, J.* ; Aboutara, N.* ; Hillemann, D.* ; Garrelts, M.* ; Converse, P.J.* ; Tyagi, S.* ; Gerbach, S.* ; Gyr, L.* ; Lemm, A.K.* ; Volz, J.* ; Hölscher, A.* ; Gröschel, L.* ; Stemp, E.M.* ; Heinrich, N.* ; Kloss, F.* ; Nuermberger, E.L.* ; Schwudke, D.* ; Hoelscher, M. ; Hölscher, C.* ; Walter, K.*

The clinical-stage drug BTZ-043 accumulates in murine tuberculosis lesions and efficiently acts against Mycobacterium tuberculosis.

Nat. Commun. 16:826 (2025)

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The development of granulomas with central necrosis harboring Mycobacterium tuberculosis (Mtb) is the hallmark of human tuberculosis (TB). New anti-TB therapies need to effectively penetrate the cellular and necrotic compartments of these lesions and reach sufficient concentrations to eliminate Mtb. BTZ-043 is a novel antibiotic showing good bactericidal activity in humans in a phase IIa trial. Here, we report on lesional BTZ-043 concentrations severalfold above the minimal-inhibitory-concentration and the substantial local efficacy of BTZ-043 in interleukin-13-overexpressing mice, which mimic human TB pathology of granuloma necrosis. High-resolution MALDI imaging further reveals that BTZ-043 diffuses and accumulates in the cellular compartment, and fully penetrates the necrotic center. This is the first study that visualizes an efficient penetration and accumulation of a clinical-stage TB drug in human-like centrally necrotizing granulomas and that also determines its lesional activity. Our results most likely predict a substantial bactericidal effect of BTZ-043 at these hard-to-reach sites in TB patients.

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