Aradigm Corporation Completes Enrollment in the Second Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
Aradigm Corporation (Nasdaq: ARDM) ("Aradigm" or the "Company") today announced the completion of enrollment in the ORBIT-3 trial, the second of the two fully enrolled Phase III pivotal clinical trials of Pulmaquin®, Aradigm's proprietary investigational formulation of inhaled ciprofloxacin, for the treatment of patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections with Pseudomonas aeruginosa.
ORBIT-3 is a worldwide, double-blind, placebo-controlled pivotal trial that enrolled 280 patients across 17 countries, including the U.S., Canada, Australia, New Zealand, Israel, South Korea, Taiwan, South Africa and countries in Europe.
"We urgently need evidenced-based treatments for non-CF BE patients with recurrent respiratory infections with Pseudomonas aeruginosa who have reduced life expectancy and poor quality of life. The ORBIT-3 and 4 trials are an important development towards the goal of meeting the needs for effective and safe antibiotic treatment options in this severely affected patient population," said Dr. Charles Haworth, MD, Clinical Director, Thoracic Medicine, Papworth Hospital, Cambridge, UK, the principal investigator for the ex-US segments of Aradigm's Phase 3 bronchiectasis program.
"Our global collaboration to identify and quantify the burden of bronchiectasis for individual patients and the national healthcare systems has raised the awareness of the need to find more effective treatments for this serious medical condition. I am very pleased to support the worldwide effort to develop Pulmaquin as a potential new treatment to reduce pulmonary exacerbations and reduce the high morbidity in these patients," said Dr. Timothy Aksamit, MD, Chairman, United States Bronchiectasis and Nontuberculous Mycobacteria Research Registry, and Pulmonary Consultant at Mayo Clinic, Rochester, MN.
The Phase III clinical program for Pulmaquin in BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. The dosing regimen for each trial consists of a 48 week double blind period of 6 cycles of 28 days on treatment/28 days off treatment with Pulmaquin or placebo, followed by a 28 day open label extension in which all participants will receive Pulmaquin. The superiority of Pulmaquin vs. placebo during the double blind period will be evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations, including severe episodes, and improvements in specific quality of life measures. Lung function is being monitored as a safety indicator.
Bronchiectasis is a severe, chronic and rare disease characterized by bronchial wall damage diagnosed as abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections and a vicious cycle of inflammation and episodes of acute worsening. In these severely affected adult patients, infections with Pseudomonas aeruginosa are associated with an approximately 3-fold increased risk of death and an increase in hospital admissions and exacerbations. Non-CF BE represents an unmet medical need that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition to prevent pulmonary exacerbations.
About Aradigm's Pulmaquin investigational product candidate
Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas aeruginosa. Pulmaquin is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of patients with non-CF BE who have chronic lung infections with Pseudomonas aeruginosa.
Following Phase 2a development of the liposomal portion of Pulmaquin (Lipoquin®) and Phase 1 development of Pulmaquin, the Phase 2b study ORBIT-2 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) with Pulmaquin was a 24-week multicenter, randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE subjects. This study demonstrated a significant reduction in P.aeruginosa sputum activity (p=0.002) and a decrease in time to first exacerbation in the per protocol population (p=0.046) and the mITT (p=0.057) populations in the Pulmaquin treated subjects compared to placebo. Overall, the incidence of all treatment emergent adverse events was similar between groups. The most frequently reported treatment related adverse events (reported by ≥ 3 patients in either treatment group) included product taste abnormal and nausea in the Pulmaquin group and wheezing in the placebo group. No serious adverse events were considered treatment related. There were no deaths reported during ORBIT-2.
Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP) for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm is currently in Phase 3 development of Pulmaquin (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis. Aradigm's inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, Q fever, melioidosis and inhaled anthrax. 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 that involve risk and uncertainties, including those related to the ORBIT-3 and ORBIT-4 clinical trials and the ability to continue successful product development of our potential product candidates, including Pulmaquin, 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, 2014 filed with the SEC on March 18, 2015, and the Company's Quarterly Reports on Form 10-Q for subsequent interim periods.
Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Nancy Pecota, 510-265-8800
Chief Financial Officer