Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced that it
dosed the first patient in the U.S. as part of its ORBIT-1 (Once-daily
Respiratory Bronchiectasis Inhalation Treatment) trial, an
international, randomized, double-blind, placebo-controlled Phase 2b
study designed to evaluate the Company's inhaled liposomal ciprofloxacin
(ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE)
under a U.S. IND. This orphan disease indication is a chronic, severe
respiratory disease and there are currently no approved treatments for
this disease in the U.S.
"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. 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," said Dr. Igor Gonda, the Company's CEO and President.
The ORBIT-1 trial, a Phase 2b study, will randomize 96 patients, who
will receive for four weeks either one of two different once-daily
inhaled doses (100 or 150 mg ciprofloxacin delivered by inhalation as 2
or 3 mL of liposomal dispersion, respectively) or once-daily inhaled
placebo. The primary efficacy endpoint will be a standard measure of
antibacterial activity - the change from baseline in sputum Pseudomonas
aeruginosa colony forming units (CFUs). Secondary endpoints will
include quality of life measurements and improvement of outcomes with
respect to exacerbations. Lung function changes will be monitored for
safety.