Gilead's aztreonam meets Ph III endpoint

US drugmaker Gilead Sciences says that a Phase III study of its drug candidate aztreonam lysine for inhalation for the treatment of cystic fibrosis complicated with pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint, the time-to-need for inhaled or intravenous antibiotics, which was assessed by the onset of common symptoms predictive of a pulmonary exacerbation.

According to the firm, data from the 247-patient study showed 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, both following a 28-day course of tobramycin inhalation solution (pooled p=0.007 by log rank test).