Aradigm gets FDA approval for Cystic drug fibrosis clinical trial

Aradigm Corporation announced  that it has received clearance from the U.S. Food and Drug Administration for its inhaled liposomal ciprofloxacin Investigational New Drug application.

Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis and non-cystic fibrosis bronchiectasis patients. It is favored because of its broad-spectrum anti-bacterial action.

The first trial planned under this IND is a multi-center study to evaluate the pharmacokinetics, safety and tolerability of a once-daily administration of 150 mg of Ciprofloxacin for inhalation in pediatric patients with cystic fibrosis, company officials said.

The Aradigm study will also include quality of life measurements, lung function changes and improvement of outcomes with respect to exacerbations.

“We are very pleased to have an opportunity to investigate the utility of ARD-3100 in young CF patients and potentially provide another therapeutic option for the pediatric population,” Dr. Igor Gonda, Aradigm's president and CEO, said. “The IND approval follows Aradigm's previously reported encouraging results in adult patients with cystic fibrosis, and in patients with non-cystic fibrosis bronchiectasis.”

Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation, reported a once-a-day inhaled antibiotic, such as ARD-3100, would reduce the treatment burden for cystic fibrosis patients and will be an advance that could improve the lives of those with the disease.

Cystic fibrosis is a life-threatening genetic disease that causes thick, sticky mucus to form in the lungs, pancreas and other organs.

Roughly 30,000 children and adults in the United States and roughly 70,000 children and adults worldwide are affected by cystic fibrosis, according to Cystic Fibrosis Foundation statistics.