Aradigm demonstrates top line data from ORBIT-1 ARD-3100 Phase 2b study for bronchiectasis

Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced positive top line data from its recently concluded Phase 2b study (Once-Daily Respiratory Bronchiectasis Inhalation Treatment - ORBIT-1) with Aradigm's ciprofloxacin for inhalation (CFI, ARD-3100, Lipoquin^TM) in patients with non-cystic fibrosis bronchiectasis (BE).

“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”

The primary endpoint - the mean change in Pseudomonas aeruginosa colony forming units per gram of sputum (CFUs) from baseline to day 28 - was met in the full analysis population: There was a significant mean reduction (p<0.001) of 2.942 log₁₀ CFUs in the 3mL ARD-3100 group and a significant mean reduction (p< 0.001) of 3.842 log₁₀ CFUs in the 2mL ARD-3100 group compared to placebos. Pooled placebo groups had a mean reduction of log₁₀ CFUs of 0.437. There was no statistically significant difference between the 2 mL and 3 mL ARD-3100 doses.

ARD-3100 was well-tolerated and no bronchodilator treatment was mandated before inhaled study treatments. There were no statistically significant differences between the active and placebo groups in the number of patients experiencing at least one respiratory treatment-emergent adverse event. The incidence of serious adverse events (SAEs) was low; there were a total of 6 SAEs and none of them were treatment related.

Additional analyses are underway that are planned to be reported at future conferences and in press releases.

The double-blind, placebo-controlled ORBIT-1 trial was conducted in Australia, Canada, United Kingdom, Germany and the United States.

"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.

"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," said Igor Gonda, Aradigm's President and CEO.