ARTICLE | Clinical News

TMC207: Phase II data

June 13, 2011 7:00 AM UTC

Data from 160 newly diagnosed MDR-TB patients in the second stage of a double-blind Phase II trial showed that TMC207 met the secondary endpoint of a significantly greater proportion of patients who had a negative sputum culture at week 24 vs. placebo (79% vs. 58%, p=0.008). Additionally, time to conversion to a negative sputum culture was 4 weeks faster for TMC207 vs. placebo. All patients also received a standard 5-drug, second-line anti-TB regimen. Based on the results, Johnson & Johnson said it plans to submit a regulatory application to FDA for the compound next year. ...