Aradigm Corporation presented data from clinical trials assessing the drug, Pulmaquin, in people with non-cystic fibrosis bronchiectasis (NCFBE) and chronic Pseudomonas aeruginosa infections, and case studies of another drug, Lipoquin, to possibly prevent non-tuberculous mycobacteria formation in the lungs. The presentations, on the company’s inhaled liposomal ciprofloxacin programs, were given at the American Thoracic Society (ATS) 2016 International Conference underway in San Francisco, California.
The first presentation, “ORBIT-3 and ORBIT-4: Design of a Phase 3 Program to Investigate Safety and Efficacy of Pulmaquin® in Non-Cystic Fibrosis Bronchiectasis (NCFBE) Patients Chronically Colonized with Pseudomonas aeruginosa (PA)” (A1775), discussed design details of these two ongoing, placebo-controlled, double-blind, and randomized Phase 3 studies. The trials are identical, except that one includes a pharmacokinetics sub-study.
Pulmaquin is a dual-release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin, an antibiotic used to treat acute lung infections due to its broad-spectrum antibacterial activity. Pulmaquin is currently under evaluation to determine its safety and effectiveness as a once-daily inhaled formulation for NCFBE patients who have developed chronic lung infections with P. aeruginosa.
NCFBE is a chronic “orphan” condition, characterized by abnormal dilatation of the bronchi and bronchioles, and associated with chronic infection. The patient’s lung function is often irreversibly reduced. Bronchiectasis is frequently observed in people with cystic fibrosis (CF), but also affects many people without CF, and results from a cycle of inflammation, recurrent infection, and bronchial wall damage.
The second presentation, “Liposome-Ciprofloxacin Inhibits Mycobacterium avium subs hominissuis (MAH) Microaggregate Formation in a Dose and Time Dependent Manner” (A3734), comes from a collaboration between Aradigm and the Oregon State University. It described the results of studies demonstrating the efficacy of Lipoquin, the liposomal portion of Pulmaquin, in inhibiting the formation of microaggregates of Mycobacterium avium subs hominissuis in the lungs.
Pulmonary infections due to non-tuberculous mycobacteria (NTM) are increasingly recognized worldwide. Although over 150 different species of NTM have been described, pulmonary infections are most commonly due to complex, and . These pulmonary infections are often treated through long-term antibiotic use, although resistance to antibiotics has been found in some mycobacteria species.
The ATS conference opened on May 13 and will conclude on May 18.