Rare Disease Report

Phase 3 Pivotal Trial for Bronchiectasis Has Started

JUNE 24, 2014
James Radke

Aradigm Corporation announced they have dosed their first patient in their phase 3 pivotal trial examining the efficacy and safety of Pulmaquin® (inhaled ciprofloxacin) for the treatment of non-cystic fibrosis bronchiectasis. 

Bronchiectasis is a widening and scarring of the lung airways often due to infections.  In bronchiectasis, the widening and scaring lead to mucus buildup in the airways, that in turn, leads to more infections and more widening and scaring. This vicious cycle eventually lead to the airways being unable to transport air and vital organs become deprived of oxygen. It is estimated to afflict 110,000 Americans with no approved treatment.

The phase 3 trial titled the ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial is the second of the two Phase 3 pivotal clinical trials  (ORBIT-3 and -4) that Aradigm is conducting to test the efficacy of Pulmaquin in non-cystic fibrosis bronchiectasis (the company is also testing Pulmaquin in patients with cystic fibrosis). ORBIT-3 and ORBIT-4 are enrolling 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 ORBIT-3 study began dosing earlier this year.

The primary endpoint in both trials is the time to first pulmonary exacerbation. Secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures.

In a press release, clinical investigator Dr. Shari Brazinsky at the Institute of HealthCare Assessment, Inc. in San Diego said, “Pulmonary exacerbations in bronchiectasis patients are always a concern as they have an immediate adverse impact on their lives and further worsen their health long term. A treatment that would cause a reduction in the frequency and severity of pulmonary exacerbations in this disease would be highly desirable”

About Pulmaquin

Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin is a widely prescribed antibiotic and often used to treat acute lung infections.

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 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-cystic fibrosis bronchiectasis and other indications to Grifols S.A.

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.
Image of bronchiectasis courtesy of wikimedia commons.

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