Aradigm Receives FDA Clearance for Clinical Trial of Inhaled Liposomal Ciprofloxacin

Aradigm Corporation today announced it received clearance from the U.S. Food and Drug Administration (FDA) for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application.

The first trial planned under this IND is a Phase 1/2a, multicenter study designed to evaluate the pharmacokinetics, safety, and tolerability of once-daily administration of 150mg (3mL) of Ciprofloxacin for Inhalation (CFI, ARD-3100) in pediatric patients with cystic fibrosis (CF) who have a history of chronic Pseudomonas aeruginosa lung infection. Secondary endpoints will include quality of life measurements, lung function changes and improvement of outcomes with respect to exacerbations.

"We are very pleased to have an opportunity to investigate the utility of ARD-3100 in young CF patients and potentially provide another therapeutic option for the pediatric population," said Dr. Igor Gonda, President and CEO of Aradigm. "The IND approval follows Aradigm's previously reported encouraging results in adult patients with cystic fibrosis, and in patients with non-cystic fibrosis bronchiectasis."

"A once-a-day inhaled antibiotic, such as ARD-3100, would reduce the treatment burden for people with cystic fibrosis and be a welcome advance that could improve the lives of those with this disease," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation.

Source: Business Wire