Moxifloxacin: Phase III data

Data from 1,931 TB patients in the per protocol (PP) population of the double-blind, international Phase III REMoxTB trial showed that both moxifloxacin-containing TB regimens missed the primary endpoint of non-inferiority to standard of care (SOC) in the rate of treatment failure or relapse at 18 months. SOC comprised rifampicin/isoniazid/ethambutol/pyrazinamide for 8 weeks followed by rifampicin/isoniazid for 18 weeks. Specifically, the rate of treatment failure or relapse at 18 months was 15% for the moxifloxacin plus rifampicin/isoniazid/pyrazinamide given for 17 weeks followed by placebo for 9 weeks regimen; 20% for the moxifloxacin plus rifampicin/ethambutol/pyrazinamide for 17 weeks followed by placebo for 9 weeks regimen; and 8% for SOC. The 2 moxifloxacin-containing regimens did produce a more rapid initial decline in bacterial load vs. SOC. Data were published in the New England Journal of Medicine and presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, D.C.

Moxifloxacin is approved to treat acute respiratory infections and other infections and is included in World Health Organization (WHO) guidelines to treat drug-resistant TB in combination with other drugs, but has never been approved by regulatory authorities for TB treatment. The TB Alliance has exclusive, worldwide rights to moxifloxacin for TB from Bayer. ...