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news.Infectious disease and respiratory drugs developer Corus Pharma has begun enrolling patients in its phase III clinical trial for aztreonam lysinate for inhalation in cystic fibrosis patients with pseudomonas.
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The multi-center, blinded, placebo controlled trial will be conducted in 50 cystic fibrosis (CF) centers in the US, and will evaluate the efficacy and safety of aztreonam lysinate for inhalation (Cayston or AI) in CF patients with pulmonary pseudomonas aeruginosa.
Aztreonam is an antibiotic that has activity against a broad spectrum of gram-negative bacteria, including pseudomonas aeruginosa, which commonly infect the lungs of CF patients. AI is a reconstituted solution which is specifically formulated for inhalation.
Inhaled delivery concentrates the drug in the lungs, the predominant site of infection in CF patients. AI is delivered by the eFlow electronic nebulizer developed by PARI GmbH with an average treatment time in Corus’ phase II clinical trial of less than three minutes.
“This is a significant milestone for the development of a potential treatment for cystic fibrosis patients and for our organization,” commented Dr Bruce Montgomery, CEO of Corus Pharma. “We look forward to the results of this study so that we can submit phase III clinical data to regulatory authorities.”