Aradigm Corporation (Nasdaq:ARDM) ("Aradigm" or the "Company") today announced the dosing of the first patient in the ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm's proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE). ORBIT-4 is the second of the two Phase III pivotal clinical trials Aradigm is conducting with Pulmaquin in non-CF BE. The Company announced the dosing of the first patient in the ORBIT-3 clinical trial in April 2014.
The first patient in ORBIT-4 was dosed by respiratory physician Dr. Shari Brazinsky at the Institute of HealthCare Assessment, Inc. in San Diego. "Pulmonary exacerbations in bronchiectasis patients are always a concern as they have an immediate adverse impact on their lives and further worsen their health long term. A treatment that would cause a reduction in the frequency and severity of pulmonary exacerbations in this disease would be highly desirable," said Dr. Brazinsky.
"Both of our Phase III 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," said Juergen Froehlich, MD, Chief Medical Officer of Aradigm.
The Phase III clinical program for Pulmaquin in BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial is enrolling approximately 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 (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double blind period is being evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator.
"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," said Igor Gonda, President and CEO of Aradigm.
Bronchiectasis is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.