Aradigm’s Inhaled CF Drug Passes Phase II Proof Of Concept

Firm slates conference call for mid-July to provide details.

Aradigm's positive top-line Phase II data with once-daily inhaled ciprofloxacin for cystic fibrosis, disclosed June 30, leaves the firm with solid proof-of-concept for the liposomal form of the antibiotic, ARD-3100.

The primary efficacy endpoint in the study was the change from baseline Pseudomonas aeruginosa colony-forming units in sputum, a measure of the reduction in pulmonary bacterial load.

In 21 patients who completed the study, Pseudomonas CFU decreased by a mean 1.43 log over the 14-day treatment period (p<0.0001).

Evaluation one week after stopping the study treatment showed the Pseudomonas bacterial density in the lung was still reduced by 1.02 log CFU from baseline.

Pulmonary function - measured by the forced expiratory volume in one second - showed a significant mean increase of 6.86 percent from baseline after 14 days of treatment (p=0.04).

Hayward, Calif.-based Aradigm said the drug was well tolerated, and there were no serious adverse events reported during the trial.

The protocol for a broader Phase II will be decided later, as the rest of the development program is discussed with FDA. Meanwhile, the firm has slated a conference call for July 16 to detail the results further.

Ciprofloxacin, a fluoroquinolone, is sold as Cipro by Bayer and available in generic form.

With United Therapeutics, of Silver Spring, Md., Aradigm is working on United's inhaled Remodulin (treprostinil) for pulmonary arterial hypertension.

Also June 30, United filed its NDA for inhaled treprostinil (¹ (Also see "United Therapeutics’ Inhaled Treprostinil May Get Second Quarter 2009 Action Date" - Pink Sheet, 30 Jun, 2008.)), and results are expected soon from a bridging study that compares the drug as given by the nebulizer used in United's trials with Aradigm's AERx Essence technology.

- Randall Osborne ([email protected])