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TB treatment remains prolonged and complex, and the increasing prevalence of multidrug-resistant TB (MDR-TB) has lowered cure rates. Novel therapies are sorely needed. Now, researchers have evaluated the safety, tolerability, pharmacokinetics, and antibacterial activity of TMC207, an investigational diarylquinoline compound that inhibits mycobacterial ATP synthase.
This industry-sponsored, phase II trial — the first of two stages — involved 47 hospitalized adults in South Africa with newly diagnosed MDR pulmonary TB. The patients were randomized to receive TMC207 or placebo, in combination with a standard, five-drug second-line treatment regimen, for 8 weeks. The primary efficacy endpoint was conversion of sputum cultures using a liquid brot…