Bronchitol mannitol: Phase III data
Top-line data from the double-blind, international Phase III DPM B305 trial in 485 patients with bronchiectasis showed that twice-daily 400 mg inhaled Bronchitol missed the primary endpoint of reducing the rate of graded pulmonary exacerbations over 52 weeks vs. placebo. Specifically, Bronchitol reduced the rate of graded pulmonary exacerbations by 8% vs. placebo (p=0.31). On secondary endpoints, Bronchitol significantly delayed time to first exacerbation by 28% (p=0.022), reduced days of antibiotics use by 24% (p=0.0496) and improved SGRQ scores by 28% (p=0.046) vs. placebo. Bronchitol missed the secondary endpoints of improving spirometric lung function, Epworth Sleep Score and hospitalizations for exacerbations vs. placebo. Based on the results, Pharmaxis said it will not immediately proceed with a regulatory submission for Bronchitol in bronchiectasis. The company said that over the coming months it will explore its options for advancing the bronchiectasis development program. ...