Primary Endpoint – Reduction in Bacterial Load - Met
Positive Trends Observed in Time to First Exacerbation and Reduced Number of Exacerbations
Statistically Significant Reduction in the Need for Other Antibiotics
HAYWARD, Calif.--(BUSINESS WIRE)-- Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced positive top line data from its recently concluded 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.
Statistical significance was achieved in the primary endpoint and one of the secondary endpoints. The primary endpoint - the mean change in Pseudomonas aeruginosa density in sputum from baseline to day 28 - was met. In the full analysis population*, there was a significant mean reduction of 4.2 log10 units in the ARD-3150 group, reflecting an almost sixteen-thousand fold decrease in bacterial load, versus a very small mean decrease of 0.1 log10 units in the placebo group (p=0.004). Secondary endpoint analysis showed that 17 subjects in the placebo group required supplemental antibiotics for respiratory-related infections versus 8 subjects in the ARD-3150 group (p=0.05).
Positive trends were observed in the key area of pulmonary exacerbations. The median time to first exacerbation was 58 days in the placebo group versus 134 days in the ARD-3150 group and there were fewer exacerbations in the treatment group compared to the placebo group. ARD-3150 was well tolerated and there were no significant decreases in lung function, as measured by FEV1 (forced expiratory volume in one second), at 28 days in either group. Overall, the incidence and severity of adverse events were similar in both the placebo and treatment groups.
Data from additional analyses of the secondary endpoints will be reported in future conferences and press releases.
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 (ARD-3150) or placebo, followed by a 28 day off-treatment period. This on-off sequence was repeated three times.
“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. 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,” said Associate Professor David Serisier of the Mater Adult Hospital, Brisbane, Australia, a pulmonary physician and the lead investigator on the study.
“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,” said Paul Bruinenberg, MD, Aradigm’s Medical Director. “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.”
"We are grateful for the support of this trial by the patients and clinicians, reflecting the great interest in finding an effective treatment for this severe respiratory disease,” said Igor Gonda, Aradigm’s president and CEO. “Our partnering discussions and interactions with FDA will now intensify with the goal to work together to make this promising therapy available for this underserved orphan patient population."
* Full analysis set includes all patients who were randomized, received at least one dose and provided samples for at least two time points.
Conference call
A teleconference will be held on Thursday, October 21, 2010, at 4:00 p.m. Eastern Time, 1:00 p.m. Pacific Time. The teleconference is accessible to US/Canada callers by dialing (866) 394-5284, with international callers dialing (+1) (706) 643-4377. The Conference ID # is 19728139. A rebroadcast of the teleconference will be available for two weeks following the teleconference by dialing (706) 645-9291 and entering Conference ID # 19728139.
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. 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 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.
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, including, but not limited to, statements regarding our future plans and expectations related to clinical trials. 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
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Research FDA Science
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