Aradigm Gets FDA Clearance For Phase IIb Ciprofloxacin Trial

Aradigm has received clearance from the FDA for phase IIb clinical trial of its inhaled liposomal ciprofloxacin’s Investigational New Drug (IND) application.

The study is a randomized, double-blind, placebo-controlled phase IIb study, designed to evaluate the company’s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis (BE).

The phase IIb study would enroll 96 patients, and the primary efficacy endpoint will be the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units following once-daily dosing of two different dose levels vs placebo for a four-week treatment period.

The secondary endpoints will include quality of life measurements and improvement of outcomes, with respect to exacerbations. Lung function changes will be monitored for safety, said the company.

Igor Gonda, president and CEO of Aradigm, said: “We are very pleased that the FDA accepted our data package to allow us to begin our Phase IIb study under a US IND with our once-a-day inhaled liposomal ciprofloxacin in BE patients. Based on the promising pre-clinical data gathered and the previous clinical work done, we are excited about bringing this therapeutic into advanced clinical trials. The fundraising we conducted earlier this year has given us the resources to immediately undertake this Phase IIb study.