HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTCBB:ARDM - News) (the “Company”) today announced it received clearance from the U.S. Food and Drug Administration (FDA) for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The initial clinical protocol under this IND is an international, randomized, double-blind, placebo-controlled Phase IIb study designed to evaluate the Company’s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis (BE). This orphan drug condition is a chronic severe respiratory disease and there is currently no drug specifically approved for its treatment in the U.S.
“We are very pleased that the FDA accepted our data package to allow us to begin our Phase IIb study under a U.S. IND with our once-a-day inhaled liposomal ciprofloxacin in BE patients. Based on the promising pre-clinical data gathered and the previous clinical work done, we are excited about bringing this therapeutic into advanced clinical trials. The fundraising we conducted earlier this year has given us the resources to immediately undertake this Phase IIb study,” said Dr. Igor Gonda, the Company’s CEO and President.
In a previously conducted Phase IIa study at eight leading centers in the United Kingdom, a total of 36 patients were enrolled and randomized into two equal size groups, one receiving 3 mL of inhaled liposomal ciprofloxacin and the other receiving 6 mL of inhaled liposomal ciprofloxacin, once-a-day for the four-week treatment period. The primary efficacy endpoint was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), the standard objective measure of the reduction in pulmonary bacterial load. The 3 mL and 6 mL doses of inhaled liposomal ciprofloxacin in the evaluable patient population demonstrated significant mean decreases against baseline in the Pseudomonas Aeruginosa CFU over the 28-day treatment period of 3.5 log (p<0.001) and 4.0 log (p<0.001) units, respectively. With regard to safety, there were no statistically significant changes in lung function at the end of treatment as measured by the normalized forced expiratory volume in one second (FEV1 % predicted). Inhaled liposomal ciprofloxacin was well tolerated; no bronchodilator use was mandated or needed before administration of the study drug. In the 3 mL group, respiratory drug-related adverse reactions were only mild.
The Phase IIb study will enroll 96 patients and the primary efficacy endpoint will be the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units following once-daily dosing of two different dose levels vs. placebo for a four-week treatment period. Secondary endpoints will include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes will be monitored for safety.
About bronchiectasis
Bronchiectasis is a chronic respiratory condition characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic infection. It is frequently observed in patients with cystic fibrosis (CF). However, it is a condition 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. The Company was granted orphan drug designation in the U.S. for the management of BE with inhaled liposomal ciprofloxacin in January 2007.
About liposomal ciprofloxacin
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by CF and 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 CF patients. The Company’s once-a-day novel inhaled formulation of ciprofloxacin delivered in liposomes 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 Company is also developing inhaled liposomal ciprofloxacin as a potential treatment for the prevention and treatment of bioterrorism infections such as inhaled anthrax.
About Aradigm
The Company is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, inhalation anthrax infections and smoking cessation.
More information about the Company 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 dosing regimens and the advancement of product development, as well as the other risks detailed from time to time in Aradigm Corporation’s Securities and Exchange Commission (SEC) Filings, including the Company’s Annual Report on Form 10-K, and quarterly reports on Form 10-Q.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Contact:
AradigmInvestor Relations, 510-265-8850/9370orInvestorsLippert/Heilshorn & AssociatesDon Markley/Bruce Voss, 310-691-7100dmarkley@lhai.com
