Both ARD-3100 Doses Met Primary Endpoint
2 mL Dose Found Equipotent to 3 mL Dose, with Excellent Safety and Tolerability
HAYWARD, Calif.--(BUSINESS WIRE)-- Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced positive top line data from its recently concluded Phase 2b study (Once-Daily Respiratory Bronchiectasis Inhalation Treatment - ORBIT-1) with Aradigm’s ciprofloxacin for inhalation (CFI, ARD-3100, LipoquinTM) in patients with non-cystic fibrosis bronchiectasis (BE).
The primary endpoint - the mean change in Pseudomonas aeruginosa colony forming units per gram of sputum (CFUs) from baseline to day 28 – was met in the full analysis population*: There was a significant mean reduction (p<0.001) of 2.942 log10 CFUs in the 3mL ARD-3100 group and a significant mean reduction (p< 0.001) of 3.842 log10 CFUs in the 2mL ARD-3100 group compared to placebos. Pooled placebo groups had a mean reduction of log10 CFUs of 0.437. There was no statistically significant difference between the 2 mL and 3 mL ARD-3100 doses.
ARD-3100 was well-tolerated and no bronchodilator treatment was mandated before inhaled study treatments. There were no statistically significant differences between the active and placebo groups in the number of patients experiencing at least one respiratory treatment-emergent adverse event. The incidence of serious adverse events (SAEs) was low; there were a total of 6 SAEs and none of them were treatment related.
Additional analyses are underway that are planned to be reported at future conferences and in press releases.
The double-blind, placebo-controlled ORBIT-1 trial was conducted in Australia, Canada, United Kingdom, Germany and the United States. Following a screening period, 95 patients, randomized into four groups (3mL ARD-3100 n=32, 2mL ARD-3100 n=30, placebo 3mL n= 15, placebo 2mL n= 18), were treated once-a-day for 28 days, followed by a 28 day off-treatment period.
“We are very pleased that we demonstrated that the 2 mL dose of ARD-3100 is equipotent to the 3 mL dose, with excellent safety and tolerability. A lower dose shortens the time of administration for the patients, which is always a welcome attribute in the management of chronic disease,” said Dr. Paul Bruinenberg, Aradigm’s Senior Medical Director.
“Now that we have the data from both the ORBIT-1 and ORBIT-2 studies, we will intensify the discussions with regulatory authorities in the U.S. and overseas to finalize plans for the remainder of the development of our inhaled ciprofloxacin for diseases with highly unmet medical need. Bronchiectasis patients in particular represent a very under-served population. On the business side, we are focused on maximizing the potential reach of our product through partnering with other pharmaceutical companies,” said Igor Gonda, Aradigm’s President and CEO.
* Full analysis set includes all patients who were randomized, received at least one dose and provided samples for at least two time points.
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, especially with Pseudomonas aeruginosa, 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. ARD-3100 (CFI, Lipoquin™) is a liposomal formulation of ciprofloxacin. ARD-3150 is a dual release formulation (DRCFI, Pulmaquin™) that is a mixture of ARD-3100 with unencapsulated ciprofloxacin. The Company previously reported positive results in Phase 2a studies of 22 CF patients and 36 BE patients who received ARD-3100 (Lipoquin) once-a-day for 2 (CF) or 4 (BE) weeks, respectively. The Phase 2b study ORBIT-2 was a 168 day, double-blind, placebo-controlled trial in 42 randomized BE patients with once daily ARD-3150 (Pulmaquin) that resulted in excellent reduction of Pseudomonas aeruginosa CFUs, as well as a significant increase in the time to first exacerbation in the active group vs. placebo. 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 has been granted orphan drug designation for liposomal ciprofloxacin for cystic fibrosis in the U.S. and the E.U., and for liposomal ciprofloxacin and for inhaled ciprofloxacin for BE in the U.S.
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, further product development, dosing schedules, administration times and partnering with other pharmaceutical companies. 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 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, 2010 filed with the SEC on March 25, 2011, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Nancy Pecota, 510-265-8800
Chief Financial Officer
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