Aradigm, an emerging pharmaceutical company dedicated to the development and commercialization of drugs to treat a wide range of respiratory ailments, recently announced the completion of patient enrollment for ORBIT (Once-daily Respiratory Bronchiectasis Inhalation Treatment)-4, a Phase III clinical trial of their investigational, inhalable ciprofloxacin formulation Pulmaquin®. The therapy is aimed at treating patients with non-Cystic Fibrosis Bronchiectasis (non-CF BE) with chronic pulmonary Pseudomonas aeruginosa infection, and the trial is one of the two phase III trials (the other being ORBIT-3) planned as a part of clinical development of the drug.
Patients have been enrolled in 16 countries, including the U.S., Canada, Australia, New Zealand, Israel, South Korea, Peru and countries throughout Europe. ORBIT-4 has recruited a total of 304 patients, and along with ORBIT-3, constitutes a global phase III trial to test the safety, efficacy and toxicity of the drug in a once-daily dose for those affected by non-CF BE using identical study models, apart from a pharmacokinetic sub-study to be conducted in one of the two study groups.
Pulmaquin, a dual release formulation comprising of a mixture of liposomal, encapsulated and unencapsulated ciprofloxacin or a placebo, is to be inhaled once-daily for 6 cycles of 28 days alternating between 28 days off treatment throughout the total study period of 48 weeks. The treatment will be followed by a 28-day open label extension in which all participants are scheduled to receive Pulmaquin. The efficacy of the drug and its superiority against the placebo would be measured against the time taken for the first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations, including severe episodes and improvements in specific quality of life measures. Lung function is to be monitored as a safety indicator.
Aradigm has already been granted orphan drug designations (ODD) for both liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP) for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa, which made it eligible for a Fast-Track designation by the US FDA, also granted, back in September 2014.
Dr. Juergen Froehlich, MD, Chief Medical Officer of Aradigm, was quoted in the press release saying, “The completion of enrollment in the first of our Phase III clinical trials is a major milestone in the development of our investigational formulation Pulmaquin. We sincerely thank our investigators and the patients with non-CF BE for participating in this important clinical trial which aims to decrease the substantial disease burden due to chronic lung infections with P. aeruginosa by reducing their frequency and improving the quality of life of these patients.”