Aradigm Enrolls 1st Patient In Phase III Trial With Pulmaquin

(RTTNews) - Aradigm Corp. (ARDM) said it enrolled the first patient in the Phase III once-daily Respiratory Bronchiectasis Inhalation Treatment or ORBIT-4 using inhaled ciprofloxacin or Pulmaquin for the treatment of non-cystic fibrosis bronchiectasis. The study consists of two global, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are similar in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial is enrolling about 255 patients into a 48 week double blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin. The superiority of Pulmaquin vs. placebo during the double blind period is being assessed in terms of the time to first pulmonary exacerbation, which is the primary endpoint, while key secondary endpoints include the reduction in the number of pulmonary exacerbation and improvements in the quality of life measures. Bronchiectasis is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. There is currently no drug approved for the treatment of this condition. Previously, Aradigm was granted with orphan drug designations for inhaled liposomal ciprofloxacin as well as for inhaled free ciprofloxacin for non-CF bronchiectasis in the U.S. In addition, FDA had designated Pulmaquin as a Qualified Infectious Disease Product or QIDP, for treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.