Aradigm Reports Positive Results From Phase II Cystic Fibrosis Study
Aradigm has announced positive results from an open-label, two week efficacy and safety study of its once daily inhaled liposomal ciprofloxacin in patients with cystic fibrosis.
The primary efficacy endpoint in this Phase II study was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load. Data analysis in 21 patients who completed the study, demonstrated that the Pseudomonas 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 Pseudomonas bacterial density in the lung 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 showed a significant mean increase of 6.86% from baseline after 14 days of treatment. The study drug was well tolerated, and there were no serious adverse events reported during the trial.
Igor Gonda, president and CEO of Aradigm, said: “The trial results will enable Aradigm to advance the development of our liposomal ciprofloxacin product for cystic fibrosis in the US, as well as pursue our strategy for other disease indications including bronchiectasis, and other geographical locations.”