Aradigm’s Bronchiectasis Therapy Advancing in Phase 3 Studies

Aradigm’s Bronchiectasis Therapy Advancing in Phase 3 Studies

Aradigm Corporation, a pharmaceutical company dedicated to the prevention and treatment of severe pulmonary diseases, recently gave an update on its promising therapy Pulmaquin, now in fully enrolled clinical studies, and announced the company’s financial results for the third quarter of 2015.

Pulmaquin is a dual release formulation comprising a mixture of liposome encapsulated and unencapsulated ciprofloxacin, a widely prescribed antibiotic with broad-spectrum antibacterial activity that is generally used to treat acute and chronic lung infections. Pulmaquin (once-a-day inhaled formulation) is currently being evaluated for safety and efficacy in two ongoing Phase 3 trials for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE). This severe, chronic and rare disease is  frequently associated with inflammation and chronic lung infections, and characterized by an abnormal dilatation of the bronchi and bronchioles. Non-CF BE has a high morbidity and mortality, and is estimated to affect more than 110,000 people in the United States.

Pulmaquin has been shown to reduce chronic lung infections with Pseudomonas aeruginosa in non-CF BE patients and to decreased the time to first exacerbation in comparison to a placebo treatment. The U.S. Food and Drug Administration (FDA) first gave Pulmaquin a Qualified Infectious Disease Product (QIDP) designation (for the treatment of non-CF BE patients with chronic lung infections with P. aeruginosa), and followed by granting it Fast Track status in September 2014 to speed its development and clinical review.

Aradigm gave the company Grifols S.A. an exclusive, worldwide license for inhaled liposomal ciprofloxacin product candidates as potential therapy for non-CF BE and other indications in 2013.

“Our two Phase 3 clinical trials testing the safety and efficacy of once daily inhaled Pulmaquin in patients with non-cystic fibrosis bronchiectasis are now fully enrolled. The focus of the Company is on the successful execution of the Phase 3 program and preparation of the regulatory filings, as well as close collaboration with our partner Grifols in expectation of commercial launch in 2017,” said Dr. Igor Gonda, President and Chief Executive Officer of Aradigm, in a press release. “We are also very pleased about the continuing stream of preclinical results showing promising utility for our liposomal ciprofloxacin against difficult infections such as pulmonary non-tuberculous mycobacteria and several inhaled bioterrorism agents.”

Regarding company finances, Aradigm reported a decrease in total revenue from $6.6 million in the third quarter of 2014 to $4.7 million in the same period in 2015. This decrease is believed to be linked to a reduction in the reimbursement values of expenses related to the Pulmaquin project under the collaboration arrangement with Grifols. In addition, the total operating expenses in the third quarter of 2015 were higher ($10.2 million) than in the same period in 2014 ($7.5 million), in part due to the research and development expenses of the ongoing Pulmaquin clinical trials.

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