Pulmaquin: Ph III ORBIT-3 and ORBIT-4 data

In December, Aradigm reported mixed data from the identical, 48-week, double-blind, international Phase III ORBIT-3 and ORBIT-4 trials of Pulmaquin in patients with non-CF bronchiectasis who have chronic P. aeruginosa lung infections. Top-line data from ORBIT-3 in 278 patients showed that once-daily inhaled Pulmaquin for the first 28 days of each of 56-day cycle for 6 cycles missed the primary endpoint of improving median time to first pulmonary exacerbation vs. placebo (221 vs. 136 days, p=0.8488). Pulmaquin also missed secondary endpoint of reducing pulmonary exacerbation frequency vs. placebo in ORBIT-3 (HR=0.87, p=0.3125).

Top-line data from ORBIT-4 in 304 patients showed that Pulmaquin met the primary endpoint vs. placebo (230 vs. 163 days, p=0.0462). Pulmaquin also met the secondary endpoint of reducing pulmonary exacerbation frequency vs. placebo in ORBIT-4 (HR=0.63, p=0.0007). In both trials, Aradigm said Pulmaquin significantly reduced P. aeruginosa density from baseline to day 28 vs. placebo (p≤0.0001 for both)...