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news.Aradigm has received FDA clearance for its inhaled liposomal Ciprofloxacin investigational new drug (IND) application.
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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.
Aradigm said that the secondary endpoints will include quality of life measurements, lung function changes and improvement of outcomes with respect to exacerbations.
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.
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. The study drug was well tolerated, and there were no serious adverse events reported during the trial.
Paul Bruinenberg, medical director of Aradigm, said: “Data from this new IND study will support inclusion of young CF patients in our future pivotal trials.”
Igor Gonda, president and CEO of Aradigm, said: “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. The IND approval follows Aradigm’s previously reported encouraging results in adult patients with cystic fibrosis, and in patients with non-cystic fibrosis bronchiectasis.”
Robert Beall, president and CEO of Cystic Fibrosis Foundation, said: “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.”