Specialty pharmaceutical company Aradigm Corp. is focused on the development of its portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases. Its portfolio includes product candidates to treat bronchiectasis, cystic fibrosis, inhalation anthrax and tularemia infections and smoking cessation.
The company today announced that statistical significance was achieved in the company’s recently concluded six-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, a lung disease in which airways enlarge.
Associate Professor David Serisier of the Mater Adult Hospital, Brisbane, Australia, a pulmonary physician and the lead investigator on the study, relayed the challenges of bronchiectasis and the impact of the positive results.
“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,” Professor Serisier stated. “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.”
The company said the study achieved the desired primary endpoint and one of the secondary endpoints, and that it would release data from additional analyses of the secondary endpoints in the future conferences and press releases.
“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,” Paul Bruinenberg, MD, Aradigm’s medical director stated. “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.”
Igor Gonda, Aradigm’s president and CEO, said the company will continue working with the FDA to bring the company’s product to market.
“Our partnering discussions and interactions with FDA will now intensify with the goal to work together to make this promising therapy available for this,” Gonda stated.
For more information visit www.aradigm.com
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