Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.

“Our partnering discussions and interactions with FDA will now intensify with the goal to work together to make this promising therapy available for this underserved orphan patient population.”

Statistical significance was achieved in the primary endpoint and one of the secondary endpoints. The primary endpoint - the mean change in Pseudomonas aeruginosa density in sputum from baseline to day 28 - was met. In the full analysis population, there was a significant mean reduction of 4.2 log₁₀ units in the ARD-3150 group, reflecting an almost sixteen-thousand fold decrease in bacterial load, versus a very small mean decrease of 0.1 log₁₀ units in the placebo group.

Positive trends were observed in the key area of pulmonary exacerbations. The median time to first exacerbation was 58 days in the placebo group versus 134 days in the ARD-3150 group and there were fewer exacerbations in the treatment group compared to the placebo group. ARD-3150 was well tolerated and there were no significant decreases in lung function, as measured by FEV1 (forced expiratory volume in one second), at 28 days in either group. Overall, the incidence and severity of adverse events were similar in both the placebo and treatment groups.

Data from additional analyses of the secondary endpoints will be reported in future conferences and press releases.

The randomized, double-blind, placebo-controlled ORBIT-2 (Once-Daily Respiratory Bronchiectasis Inhalation Treatment) trial was conducted in Australia and New Zealand. Following a screening period, 42 patients, randomized into two equal sized groups, were treated once-a-day for 28 days with either the active drug (ARD-3150) or placebo, followed by a 28 day off-treatment period. This on-off sequence was repeated three times.

"Non-cystic fibrosis bronchiectasis patients colonized by Pseudomonas aeruginosa suffer repeated airway infections that substantially impact their quality of life and there is an urgent need for effective therapies. Unfortunately, there have been significant tolerability issues with prior studies of inhaled antibiotics in bronchiectasis, so the favorable safety and tolerability seen in this study are particularly encouraging. The positive microbiologic and clinical outcome data warrant proceeding to a Phase 3 trial of ARD-3150 for bronchiectasis patients and potentially for other patient populations with chronic pulmonary Pseudomonas aeruginosa colonization," said Associate Professor David Serisier of the Mater Adult Hospital, Brisbane, Australia, a pulmonary physician and the lead investigator on the study.

"The magnitude of the antimicrobial efficacy response confirms the results from our previous Phase 2a study with our once-daily inhaled treatments, demonstrating a significant reduction in the need for additional antibiotic treatment," said Paul Bruinenberg, MD, Aradigm's Medical Director. "We are also pleased to see this translating into the potential for a meaningful positive impact on delay in time to first exacerbation. Pulmonary exacerbations are not only traumatic for patients and their relatives, but also costly to treat."

"We are grateful for the support of this trial by the patients and clinicians, reflecting the great interest in finding an effective treatment for this severe respiratory disease," said Igor Gonda, Aradigm's president and CEO. "Our partnering discussions and interactions with FDA will now intensify with the goal to work together to make this promising therapy available for this underserved orphan patient population."