The FDA has cleared Aradigm’s Investigational New Drug Application (IND) for a Phase 3 clinical trial of Pulmaquin dual release ciprofloxacin for inhalation in non-cystic fibrosis bronchiectasis. The Phase 3 program include two one-year placebo-controlled trials with 250 patients each. The company announced plans for the trials in December, 2011.
Aradigm President and CEO Igor Gonda welcomed the clearance, saying, “We are very pleased with the outcome of our interactions with FDA and the European Medicines Agency on the design of our Phase 3 program for Pulmaquin. The IND clearance represents the achievement of an important milestone for Pulmaquin. This once daily inhaled antibiotic has the potential to become an important chronic treatment for the management of bronchiectasis patients with Pseudomonas aeruginosa lung infections that are the major cause of poor quality of life and reduced life expectancy. Pulmaquin has been tested extensively in preclinical tests as well as in the ORBIT-2 Phase 2b bronchiectasis study which found excellent antimicrobial activity coupled with good safety and tolerability and, most importantly, a positive impact on prevention of pulmonary exacerbations compared to placebo. We look forward to beginning our Phase 3 program with a strategic partner.”
Read the Aradigm press release.
