Aradigm Corporation has received a $5 million milestone payment from Grifols S.A. for dosing of the first patient in a phase III study of the ORBIT-3 (once-daily respiratory bronchiectasis inhalation treatment) trial. The clinical trial aims to test inhaled ciprofloxacin (Pulmaquin) in non-cystic fibrosis bronchiectasis (non-CF BE) patients.
The study consists of two worldwide, double-blind, placebo-controlled trials (ORBIT-3 and ORBIT-4). The only difference between the two is a pharmacokinetics sub-study which will be performed in one of the trials. 255 patients will participate in it during a 48 week double blind period. During six cycles of 28 days, patients will receive either Pulmaquin or placebo. The cycles will be followed by a 28 days period off treatment and another period of the same time in which all participants will receive Pulmaquin.
The entire process will take about a year, during which the researchers will evaluate the benefits of Pulmaquin, compared to placebo, through analysis of the first pulmonary exacerbation in participants. Other features that will be monitored are the reduction in the number of pulmonary exacerbations and improvements in the quality of life. Lung function will serve as a safety indicator.
“I am pleased that our team has achieved this very important milestone, which also further strengthens our financial position,” said Nancy Pecota, Chief Financial Officer, Aradigm.
Bronchiectasis is a chronic and rare disease that causes an abnormal dilatation of the bronchi and bronchioles. Chronic lung infections is another frequent, serious symptom of the disease. Bronchiectasis can be caused by a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE affects about 110,000 people in the U.S. and registers high rates of morbidity and mortality. However, there is currently no approved drug to treat it.