BioCentury
ARTICLE | Clinical News

Delamanid: Phase IIb data

June 11, 2012 7:00 AM UTC

A double-blind, international Phase IIb trial in 481 patients aged 18-64 with suspected MDR-TB infection showed that twice-daily 100 and 200 mg delamanid in combination with standard background regimen for multidrug-resistant TB each met the primary endpoint of a greater proportion of patients with sputum-culture conversion in liquid broth medium cultured using the Mycobacterial Growth Indicator Tube system at 2 months vs. placebo plus background therapy (45.4% and 41.9%, respectively, vs. 29.6%, p=0.008 and p=0.04). Low- and high-dose delamanid also met the secondary endpoint of a greater proportion of patients achieving sputum-culture conversion at 2 months in solid medium vs. placebo (53.8% and 65.2% vs. 33.6%, p=0.002, p<0.001). At week 5, 24% of patients receiving low-dose delamanid and 23% of patients receiving high-dose delamanid achieved sputum-culture conversion vs. 13% for placebo. ...