Lipoquin liposomal ciprofloxacin: Phase IIb data

Top-line data from the double-blind, international Phase IIb ORBIT-1 trial in 95 evaluable patients showed that once-daily 2 and 3 mL ARD-3100 each met the primary endpoint of significantly reducing mean P. aeruginosa CFUs per gram of sputum from baseline to day 28 vs. placebo (3.842 and 2.942 log10 CFUs/gram, respectively, vs. 0.437 log10 CFUs/gram, p<0.001 for both). There was no significant difference between the 2 and 3 mL ARD-3100 doses. ARD-3100 was well tolerated with no significant differences between treatment groups in the number of patients experiencing >=1 respiratory treatment-emergent adverse event. ...