HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTCBB:ARDM) (“Aradigm” or the "Company") today announced that the Company’s Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of Pulmaquin (dual release ciprofloxacin for inhalation) in non-cystic fibrosis bronchiectasis (BE) has been cleared by the U.S. Food and Drug Administration (FDA).
“We are very pleased with the outcome of our interactions with FDA and the European Medicines Agency on the design of our Phase 3 program for Pulmaquin. The IND clearance represents the achievement of an important milestone for Pulmaquin. This once daily inhaled antibiotic has the potential to become an important chronic treatment for the management of bronchiectasis patients with Pseudomonas aeruginosa lung infections that are the major cause of poor quality of life and reduced life expectancy. Pulmaquin has been tested extensively in preclinical tests as well as in the ORBIT-2 Phase 2b bronchiectasis study which found excellent antimicrobial activity coupled with good safety and tolerability and, most importantly, a positive impact on prevention of pulmonary exacerbations compared to placebo,” said Igor Gonda, PhD, Aradigm’s president and chief executive officer. “We look forward to beginning our Phase 3 program with a strategic partner.”
About Pulmaquin
Pulmaquin (DRCFI, ARD-3150) is a once-a-day novel inhaled formulation consisting of a proprietary mixture of unencapsulated ciprofloxacin and ciprofloxacin encapsulated in liposomes, allowing for both immediate and sustained release of the drug within the lung. Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in BE patients. Pulmaquin is to be used for chronic maintenance therapy as it is expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. The ORBIT-2 Phase 2b study with Pulmaquin demonstrated positive results with outstanding antimicrobial activity and a significant impact on the prevention of pulmonary exacerbations. The Phase 3 clinical program for BE will consist of two identical placebo controlled trials enrolling approximately 250 patients per trial with one year duration and a design similar to the ORBIT-2 trial. Aradigm has been granted orphan drug designation for inhaled ciprofloxacin for BE in the U.S.
About bronchiectasis
Bronchiectasis is a chronic condition characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic respiratory infections. It is frequently observed in patients with cystic fibrosis. It is a condition, however, that affects about 110,000 people without cystic fibrosis in the United States and many more in other countries, and results from a cycle of inflammation, recurrent infection, and bronchial wall damage. There is currently no drug specifically approved for the treatment of this condition in the U.S.
About Aradigm
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases by pulmonologists. The Company has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation tularemia and anthrax infections, and prevention of respiratory and other diseases in tobacco smokers through smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Forward-Looking Statements
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the timing and results of future clinical trials and treatment effectiveness of the Company’s formulations, as well as the other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2010, filed with the SEC on March 25, 2011, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.