Aradigm to Report Expanded Results from Successful Six-Month Phase 2b Bronchiectasis Study at Biotech Showcase 2011
Primary Endpoint – Reduction in Bacterial Load - Met
Statistically Significant Secondary Endpoints of Delay to First Exacerbation and Reduction in the Need for Other Antibiotics
HAYWARD, Calif.--(BUSINESS WIRE)--Jan 6, 2011 - Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced that President and Chief Executive Officer, Igor Gonda, Ph.D., will present at Biotech Showcase 2011 on Tuesday, January 11, 2011, at 4:45 p.m. Pacific time. The event will be held at Parc 55 Wyndham – Union Square Hotel, San Francisco, California.
Dr. Gonda will present expanded 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 non-cystic fibrosis bronchiectasis. The study resulted in an unprecedented success for the use of inhaled antibiotics in non-cystic fibrosis bronchiectasis 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.
“We are very pleased that this 6-month study confirmed our working hypothesis that carefully designed release of ciprofloxacin in the lung can effectively manage infections with Pseudomonas aeruginosa in non-cystic fibrosis bronchiectasis patients without causing airway irritation – the problem that has previously prevented the development of effective inhaled antibiotics for the management of chronic lung colonization with this difficult microorganism in this patient population. We are engaged in discussions with several potential parties to develop this treatment to address this serious unmet medical need in respiratory medicine,” said Dr. Igor Gonda, President and CEO, Aradigm Corporation.
Interested parties can access a live audio webcast and slide presentation at www.aradigm.com. An archived presentation will be available on the Company's Web site for 14 days.
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 (DRCFI, ARD-3150) or placebo, followed by a 28 day off-treatment period. This on-off sequence was repeated three times.
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 presence of 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 in 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. A double-blind, placebo-controlled study in 96 bronchiectasis patients treated with ARD-3100 for 28 days (ORBIT-1) is currently underway. 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.
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.
Except for the historical information contained herein, this news release contains forward-looking statements, including, but not limited to, statements regarding our future plans and expectations related to clinical trials and partnerships. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated therein, including, but not limited to, the costs, timing and results of clinical trials, the risk that results of later stage clinical trials may not be as favorable as earlier trials, uncertainties concerning FDA and other government regulation and the need to obtain and maintain regulatory approval, 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.
Contact: Aradigm Corporation
Nancy Pecota, 510-265-9370
Chief Financial Officer
Posted: January 2011