Aradigm's Phase 2b study of ORBIT-2 (Once-Daily Respiratory Bronchiectasis Inhalation Treatment) with once-daily dual release Ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis has met primary endpoint and one of the secondary endpoints.
ORBIT-2 trial, a randomised, double-blind, placebo-controlled ORBIT-2 trial was conducted in Australia and New Zealand.
The primary endpoint was the mean change in Pseudomonas aeruginosa density in sputum from baseline to day 28.
ARD-3150 was well tolerated and there were no significant decreases in lung function, as measured by FEV1 (forced expiratory volume in one second), at 28 days in either group, Aradigm said.
Mater Adult Hospital, Brisbane, Australia, associate professor and lead investigator of the study David Serisier said that the positive microbiologic and clinical outcome data warrant proceeding to a Phase 3 trial of ARD-3150 for bronchiectasis patients and potentially for other patient populations with chronic pulmonary Pseudomonas aeruginosa colonisation.
Aradigm medical director Paul Bruinenberg said that the magnitude of the antimicrobial efficacy response confirms the results from the previous Phase 2a study with their once-daily inhaled treatments, demonstrating a significant reduction in the need for additional antibiotic treatment.
Aradigm president and CEO Igor Gonda said that they were grateful for the support of the trial by the patients and clinicians.