Aradigm set to begin Phase 2b study of inhaled ciprofloxacin

The Aradigm Corporation, a specialty pharmaceutical corporation that focuses on the development of inhalation drugs for severe respiratory conditions including inhalation tularemia and anthrax infections, has enrolled its final patient in a Phase 2b study for inhaled ciprofloxacin.

The study will evaluate the drug in patients that have non-cystic fibrosis bronchiectasis, which is a severe progressive respiratory disease with no current approved treatment in the United States. If successful, these formulations may become a potential medication for the treatment and prevention of bioterrorism infections, including inhaled tularemia and anthrax.

An earlier study using the once-daily dual release ciprofloxacin for inhalation found that the medication had significant impact on lung infections and excellent tolerability and safety. The new study is an international, placebo-controlled, double-blind study with 101 randomized patients. It is being conducted under a U.S. Food and Drug Administration IND.

The study will test the active drug versus the placebo over the course of four weeks and will also test two different doses of 100 milligrams or 150 milligrams of ciprofloxacin. The efficacy endpoint will be a standard measure of antibacterial activity.

BE is a disease that affects close to 110,000 patients in the United States and another 210,000 or so in Western Europe.