Hayward, Calif. — (Business Wire)—March 22, 2011 – Aradigm Corporation (OTCBB:ARDM) announced the last patient was enrolled in a Phase 2b study designed to evaluate the Company’s inhaled liposomal ciprofloxacin (CFI, ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE), a severe progressive respiratory disease for which there is currently no approved treatment in the U.S.
BE is an orphan disease that afflicts approximately 110,000 patients in the U.S. and another roughly 210,000 in Western Europe.
The Phase 2b trial, designated ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) is an international, double-blind, placebo-controlled study which randomized 101 patients and is being conducted under a U.S. Food and Drug Administration IND. The ORBIT-1 study design calls for four weeks of once-daily inhaled doses of the active drug or once-daily inhaled placebo. Two doses of the active drug are included in the study - 100 or 150 mg ciprofloxacin delivered by inhalation as 2 or 3 mL of liposomal dispersion, respectively.
The primary efficacy endpoint is a standard measure of antibacterial activity - the change from baseline in sputum Pseudomonas aeruginosa colony forming units (CFUs). Secondary endpoints include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes are being monitored for safety.
Earlier Study: Significant Impact on Lung Infections, Excellent Safety
The Company previously announced results from the 6-month Phase 2b study (ORBIT-2) with Aradigm’s once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with BE. The study resulted in an unprecedented success for the long term use of inhaled antibiotics in BE patients and demonstrated a significant impact on lung infections coupled with excellent safety and tolerability. Importantly, the Kaplan-Meier analysis showed that the median time to first pulmonary exacerbation in the per protocol evaluation increased from 58 days in the placebo group to 134 days in the active treatment group and was statistically significant (p<0.05, log rank test). DRCFI also had a superior pulmonary safety profile reflected in the number and severity of pulmonary adverse events.Furthermore, there was a statistically significant lower need to initiate antibiotics in the active group versus the placebo group to treat respiratory infections.
The results from each of these trials will produce an extensive data base of information from which to select the optimum product and the most appropriate endpoints to test in Phase 3.
About bronchiectasis
Bronchiectasis (BE) is a progressive lung disease in which the airway walls are chronically inflamed. This is often the result of a vicious cycle of bacterial infection, in which damage to the lungs further predisposes the lung to more infections. The body repairs the damaged lung tissue by forming tough, fibrous material, which leads to changes that impair normal lung structure and function. Recurrent lung infections reduce the patient’s quality of life and progressive respiratory insufficiency is the most common cause of death. The colonization of the lung with the microorganism Pseudomonas aeruginosa is associated with the severity of BE. Exacerbations in this patient population often require hospitalization and administration of intravenous antibiotics. BE is frequently observed in patients with cystic fibrosis (CF), however, it is a condition that affects about 110,000 people without CF in the United States and many more in other countries. There is currently no drug specifically approved for the treatment of this condition in the U.S.
About liposomal ciprofloxacin
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and 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 CF patients. The Company’s once-a-day novel inhaled formulations of ciprofloxacin are encapsulated in liposomes, allowing for a sustained release of the drug within the lung and improving airway tolerability. The formulations are to be used for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. The Company previously reported positive results from its 6-month Phase 2b study (ORBIT-2) with Aradigm’s once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) and other Phase 2a studies of 22 CF patients and 36 BE patients who received ciprofloxacin for inhalation (CFI, ARD-3100) once-a-day for 2 (CF) or 4 (BE) weeks,respectively. The Company is also developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia.
About Aradigm
Aradigm 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. The Company has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation anthrax and tularemia infections, and 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 clinical trials, 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, 2009 filed with the SEC on March 24, 2010, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
SOURCE: Aradigm Corporation
Contact: Nancy Pecota, Chief Financial Officer, 510-265-9370
