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news.Gilead Sciences has said that its phase III study of aztreonam lysine for inhalation for the treatment of cystic fibrosis met its primary efficacy endpoint.
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The study was designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine, as well as its ability to maintain or improve clinical status following a 28-day treatment course of tobramycin inhalation solution therapy. The study evaluated cystic fibrosis patients who have pulmonary pseudomonas aeruginosa.
The main endpoint of the trial was time to need for inhaled or intravenous (IV) antibiotics, which was assessed by the onset of common symptoms predictive of a pulmonary exacerbation. Data from the study demonstrated a significant improvement in time to need for inhaled or IV antibiotics after a 28-day treatment course of aztreonam lysine for inhalation compared to placebo.
“We look forward to further defining the role of both the twice daily and three times daily dosing in our ongoing open-label study, where we continue to gather longer-term data on more than 190 patients,” commented Dr Bruce Montgomery, senior vice president, head of Respiratory Therapeutics for Gilead Sciences.
Data from this analysis have not been reviewed by the FDA. This trial is one of three phase III studies in the aztreonam lysine clinical program.