A Phase 2b study of Aradigm’s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchietasis has shown a significant reduction in Pseudomonas aeruginosa colony forming units per gram of sputum (CFUs) over a 28-day treatment period. The double blind ORBIT-1 (Once-Daily Respiratory Bronchiectasis Inhalation Treatment) study involved 95 patients in the US, UK, Germany, Canada, and Australia.
The products, ARD-3100, or Lipoquin, involved in this study is one component of the company’s dual release formulation ARD-3150, or Pulmaquin, which was recently granted orphan drug designation in the US. The company released positive results for Pulmaquin in the ORBIT-2 trial, another Phase 2b study that showed significant reduction in CFUs.
“We are very pleased that we demonstrated that the 2 mL dose of ARD-3100 is equipotent to the 3 mL dose, with excellent safety and tolerability. A lower dose shortens the time of administration for the patients, which is always a welcome attribute in the management of chronic disease,” said Dr. Paul Bruinenberg, Aradigm’s Senior Medical Director.
Igor Gonda, President and CEO of the company commented, “Now that we have the data from both the ORBIT-1 and ORBIT-2 studies, we will intensify the discussions with regulatory authorities in the U.S. and overseas to finalize plans for the remainder of the development of our inhaled ciprofloxacin for diseases with highly unmet medical need. Bronchiectasis patients in particular represent a very under-served population. On the business side, we are focused on maximizing the potential reach of our product through partnering with other pharmaceutical companies.”
Read the Aradigm press release.
