Aradigm Corporation has received clearance from the 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 150 mg (3 mL) 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 the Company. “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.
Data analysis from a previously reported study with CFI in adult CF patients demonstrated that the P. aeruginosa Colony Forming Units (CFU) decreased by a mean 1.43 log over the 14-day treatment period (p<0.0001). Evaluation one week after study treatment was discontinued showed that the P. aeruginosa bacterial density was still reduced by 1.02 log CFU from the baseline without additional antibiotic use. Pulmonary function testing as measured by the forced expiratory volume in one second (FEV1) showed a significant mean increase of 6.9% from baseline after 14 days of treatment (p0.04). The study drug was well tolerated, and there were no serious adverse events reported during the trial. “Data from this new IND study will support inclusion of young CF patients in our future pivotal trials,” said Dr. Paul Bruinenberg, the Company’s Medical Director. About cystic fibrosis
Cystic fibrosis is a life-threatening genetic disease that causes thick, sticky mucus to form in the lungs, pancreas and other organs. In the lungs, the mucus tends to block the airways, causing lung damage and making these patients highly susceptible to lung infections. According to the Cystic Fibrosis Foundation (CFF), CF affects roughly 30,000 children and adults in the United States (about 55 percent of the patients in the CFF Patient Registry are children), and roughly 70,000 children and adults worldwide. According to the American Lung Association, the direct medical care costs for an individual with CF are currently estimated to be in excess of $40,000 per year. The Company was granted orphan drug designation in the US and EU for the management of CF with inhaled liposomal ciprofloxacin.