According to Aradigm, the first patient in the Phase 3 ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial of Pulmaquin inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis has been dosed. The other Phase 3 trial, ORBIT-3, began in April 2014.
Both 48-week double-blind trials expect to enroll about 255 patients and will be followed by a 28-day open label extension. The primary endpoint for both studies is time to first exacerbation, with secondary endpoints including quality of life factors and number of exacerbations.
Aradigm Chief Medical Officer Juergen Froehlich commented, “Both of our Phase 3 trials are now globally proceeding. The QIDP Designation will provide us with the opportunity for expedited regulatory interactions to make a potential new treatment for non-cystic fibrosis bronchiectasis more expeditiously available to many patients with this severe condition.”
President and CEO Igor Gonda added, “Our experience from recent international meetings confirms that non-cystic fibrosis bronchiectasis is a serious, growing healthcare problem. The pulmonary infections with Pseudomonas aeruginosa are of particular concern in this patient population. We have established a network of multi-national international collaborations to help us in the execution of the ORBIT-3 and 4 trials.”
Read the Aradigm press release.
