GILEAD'S LUNG INFECTION STUDY MEETS PRIMARY ENDPOINT

Gilead Sciences has announced that its Phase III AIR-CF2 study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint -- the 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 247-patient 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 with placebo, both following a 28-day treatment course of tobramycin inhalation solution.

AIR-CF2 was a randomized, double-blind, placebo-controlled study 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 in people with CF who have pulmonary P. Aeruginosa. Patients were randomized to receive 28 days of treatment with 75 mg of aztreonam lysine or volume-matched placebo administered twice or three times daily using the eFlow Electronic Nebulizer. Following an overall study period of 126 days, patients were eligible to enter AIR-CF3, an open-label, follow-up study.

The most common treatment-emergent adverse events were cough, productive cough, nasal congestion, respiratory tract congestion and wheezing. The incidence of these events did not differ significantly between the placebo and the aztreonam lysine groups.

Aztreonam lysine has potent activity against Gram-negative bacteria such as P. Aeruginosa, according to Gilead. Aztreonam formulated with arginine is an FDA-approved agent for intravenous administration. Aztreonam lysine for inhalation is a proprietary inhaled formulation of aztreonam and has been granted FDA orphan drug status.