The first patient has received treatment in Aradigm Corporation’s Phase 3 Clinical Trial known as Once-daily Respiratory Bronchiectasis Inhalation Treatment (ORBIT-3). Respiratory physician Dr. Douglas Fiedler of Nebraska Pulmonary Specialties, LLC, administered Aradigm’s proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) to a patient with non-cystic fibrosis bronchiectasis. “I am very pleased to participate in this study to investigate the potential benefits of a new medication for my patients with a chronic debilitating respiratory disease for which we do not have any good evidenced-based treatments yet,” said Dr. Fiedler in a news release.
ORBIT-3 is one of two active phase 3 trials (the other is ORBIT-4) from Aradigm evaluating the safety and efficacy of Pulmaquin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa. Both trials aim to enroll 255 patients from multiple centers around the world. “With our Phase 3 trials under way now, it is gratifying that many clinicians around the world will be joining our effort to find a treatment for an unmet medical need in patients with the severe condition of non-cystic fibrosis bronchiectasis,” said Juergen Froehlich, MD, Chief Medical Officer of Aradigm.
The ORBIT trials are identical except for the addition of a pharmacokinetics sub-study to one. Patients will cycle six times between treatment (Pulmaquin or placebo) for 28 days and no treatment for 28 days. Following this period, patients will continue into a 28 day open label extension where all patients receive Pulmaquin treatment. The efficacy of Pulamquin will be assessed against placebo by determining a difference in the time to first pulmonary exacerbation between the two groups. The number of pulmonary exacerbations, patient quality of life, and lung function will be used for secondary points of evaluation.
Pulmaquin is a promising agent for the ORBIT trials because ciprofloxacin is a common antibiotic used to treat acute lung infections and has antibacterial activity against many bacteria species, including P. aeruginosa. It showed positive results in phase 1 and 2 trials after it completed preclinical studies in animal models. Ciprofloxacin is currently available for oral and intravenous delivery, but the formulation used in these trials is an inhaled drug with dual release because Pulmaquin is a mixture of liposome encapsulated and unencapsulated ciprofloxacin. It has orphan drug designation, which enables its progression through clinical trials despite a small patient base. “The start of the Phase 3 program in non-cystic fibrosis bronchiecstasis is marking the accomplishment of a critical milestone for Aradigm,” said Igor Gonda, President and CEO of Aradigm. “We are grateful for the interest of patients with this disease to participate in this program, as well as for the support that we have been receiving from the COPD Foundation Bronchiectasis Consortium Registry.”
Both ORBIT trials are projected to end in September 2016, and results may enable Aradigm to add Pulmaquin to its list of therapeutics. The pharmaceutical company develops and commercializes inhaled drugs to treat severe diseases such as non-cystic fibrosis bronchiectasis and cystic fibrosis and bioterrorism infections such as pneumonic plague and anthrax.