The American Thoracic Society (ATS) is hosting the ATS 2016 International Conference through May 18 in San Francisco, Calif. Aradigm, an emerging pharmaceutical focused on drugs for the prevention and treatment of severe respiratory diseases, came into the conference slated to feature two presentations.
According to a press release, the company is currently developing a Phase 3 trial on Pulmaquin®, an investigational proprietary formulation of ciprofloxacin for inhalation, for the treatment of non-cystic fibrosis bronchiectasis (NCFBE). Aradigm’s inhaled ciprofloxacin formulations are also candidates for treating cystic fibrosis (CF), non-tuberculous mycobacteria, and the potential prevention and treatment of high-threat and bioterrorism infections.
Aradigm’s first presentation, staged May 15, discussed design details of the ongoing Phase 3 clinical studies with the poster 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.”
Aradigm’s second presentation, 9 a.m. – 4:15 p.m. today (May 16), will explain the results of an Oregon State University research study demonstrating that Aradigm’s investigational drug Lipoquin® (the liposomal portion of Pulmaquin) inhibited the formation of micro-aggregates of Mycobacterium Avium Subsp Hominissuis. The micro-aggregates are the first step in the formation of biofilm from non-tuberculous mycobacteria (NTM) in human lungs. The poster presentation is called “Liposome-Ciprofloxacin Inhibits Mycobacterium avium subs hominissuis (MAH) Microaggregate Formation in a Dose and Time Dependent Manner.”
A 2015 research study concluded that Pseudomonas aeruginosa affected NCFBE patients the greatest. Aradigm developed Pulmaquin as a dual release formulation, composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin is a widely prescribed antibiotic, used to treat acute lung infections due to its broad-spectrum antibacterial activity. Pulmaquin is currently under evaluation in two ongoing Phase 3 clinical studies to determine the candidate’s safety and effectiveness as a once-daily inhaled formulation for NCFBE patients who have developed chronic lung infections with P. aeruginosa.
NCFBE is a serious condition, characterized by abnormal dilatation of bronchi and bronchioles. It is linked to a high morbidity and mortality rate, and is estimated to affect more than 110,000 people in the United States and more than 200,000 in Europe.
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