Aradigm advances work on inhaled lipsomal ciprofloxacin

Aradigm Corporation has announced that is has dosed its first U.S. patient as part of its Once-daily Respiratory Bronchiectasis Inhalation Treatment trial.

The international, randomized, double-blind, placebo-controlled Phase 2b study is designed to evaluate Aradigm's inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis.

Cirpofloxacin is a widely prescribed antibiotic used in treating infections of the lung through oral and intravenous formulations. The inhaled formulas are expected to achieve higher antibiotic concentration at the site of infection and to be used as a potential treatment for the prevention and treatment of bioterrorism infections, including inhaled anthrax.

"The initiation of our ORBIT-1 trial, the second Phase 2b trial with our once-a-day inhaled liposomal ciprofloxacin formulations in BE patients, is another important milestone in developing new therapies for this underserved patient population," Dr. Igor Gonda, Aradigm's CEO and president, said. "We have been fortunate to assemble an excellent international clinical investigators team for this trial. We expect to be able to report the results of this study in the second half of 2010."

The ORBIT-1 trial calls for randomizing 96 patients who will receive either one of two different one-daily inhaled doses for four weeks or a once-daily inhaled placebo.

The primary efficacy endpoint will be a standard measure of antibacterial activity. Secondary endpoints will include quality of life measurements as well as improvement of outcomes with respect to exacerbations. Additionally, lung function changes will be monitored for safety.