Enrollment complete in Aradigm's inhaled ciprofloxacin Phase 2b study in non-cystic fibrosis bronchiectasis

Aradigm Corporation (OTCBB:ARDM) announced the last patient was enrolled in a Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (CFI, ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE), a severe progressive respiratory disease for which there is currently no approved treatment in the U.S.

BE is an orphan disease that afflicts approximately 110,000 patients in the U.S. and another roughly 210,000 in Western Europe.

The Phase 2b trial, designated ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) is an international, double-blind, placebo-controlled study which randomized 101 patients and is being conducted under a U.S. Food and Drug Administration IND. The ORBIT-1 study design calls for four weeks of once-daily inhaled doses of the active drug or once-daily inhaled placebo. Two doses of the active drug are included in the study - 100 or 150 mg ciprofloxacin delivered by inhalation as 2 or 3 mL of liposomal dispersion, respectively.

The primary efficacy endpoint is a standard measure of antibacterial activity - the change from baseline in sputum Pseudomonas aeruginosa colony forming units (CFUs). Secondary endpoints include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes are being monitored for safety.