Aradigm Corporation announced it received clearance from the FDA to begin a Phase 2b study for its inhaled liposomal ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis (BE). This study will enroll 96 patients and the primary efficacy endpoint will be the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units following once-daily dosing of two different dose levels vs. placebo for a four-week treatment period. Secondary endpoints will include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes will be monitored for safety.
Ciprofloxacin is a broad-spectrum antibiotic that is used to treat lung infections frequently experienced by cystic fibrosis (CF) and BE patients. Aradigm’s once-a-day inhaled liposomal ciprofloxacin formulation is an Investigational New Drug (IND). It is being studied for chronic maintenance therapy as it is expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects.
For more information call (510) 265-9000 or visit www.aradigm.com.