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Aradigm Receives $5 Million Milestone For Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis

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Wednesday, June 04, 2014

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Aradigm Corporation announced that it has received the $5 million milestone payment from Grifols S.A. for the dosing of the first patient in the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm's proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE).

"I am pleased that our team has achieved this very important milestone, which also further strengthens our financial position," said Nancy Pecota, Chief Financial Officer, Aradigm.

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. Each trial will enroll approximately 255 patients into a 48 week double blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28-day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). 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 and improvements in the quality of life measures. Lung function will be monitored as a safety indicator. The first patient in the ORBIT-3 trial was dosed on April 29, 2014.

Bronchiectasis is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality 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.

About Pulmaquin

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 a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. It is being evaluated in two Phase III studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of non-CF BE. The ORBIT-3 study began dosing patients in April 2014 and ORBIT-4 will begin dosing patients in 1H 2014.

Pulmaquin has been extensively tested through preclinical studies and a Phase IIb study (ORBIT-2). Previous studies have demonstrated no significant clinical safety concerns.

Aradigm has been granted orphan drug designations for inhaled liposomal ciprofloxacin as well as for inhaled free ciprofloxacin for non-CF bronchiectasis in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP). The QIDP designation is granted for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa.

In 2013, Aradigm granted an exclusive, world-wide license for the Company's inhaled liposomal ciprofloxacin product candidates for the indication of non-CF BE and other indications to Grifols S.A. More information on the terms of this license may be found in the Company's Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 13, 2014.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases. Aradigm has product candidates addressing the treatment of non-CF BE, cystic fibrosis and prevention of respiratory and other diseases in tobacco smokers through smoking cessation. Aradigm is also developing Pulmaquin and a liposomal ciprofloxacin formulation as potential medications for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, Q fever and inhaled anthrax. In addition, Aradigm's liposomal ciprofloxacin formulations are being tested against pulmonary non-tuberculous mycobacterial infections in preclinical studies funded by NIH.

Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.

Contact:

Aradigm Corporation

Nancy Pecota

Aradigm Chief Financial Officer

510-265-8800

 

Source: Aradigm Corporation
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