Cayston aztreonam lysine: Additional Phase III data

Additional data from the open-label, U.S. and European Phase III Study 205-0110 trial in 268 patients showed that Cayston met the co-primary endpoint of superiority to inhaled tobramycin in mean change in percent predicted FEV1 across 3 treatment cycles over 6 months (2.05% increase vs. 0.66% decrease, p=0.0023). In June, Gilead reported that Cayston met the other co-primary endpoint, non-inferiority to inhaled tobramycin in mean percent change from baseline in percent predicted FEV1 at day 28 (8.35% vs. 0.55% increases, p=0.0001) (see BioCentury, June 21).

On secondary endpoints, Cayston led to significant 31% reductions in both respiratory hospitalizations (p=0.44) and the total number of respiratory events requiring IV and/or inhaled anti-pseudomonal antibiotics (p=0.004) compared to inhaled tobramycin at 6 months. Furthermore, there was an adjusted mean treatment difference of 4.1 in the CFQ-R respiratory symptoms score from baseline over 6 months for patients receiving Cayston vs. inhaled tobramycin (p=0.0189). The most common adverse events were cough, pyrexia, pharyngolaryngeal pain, nasal congestion and wheezing. Data were presented at the North American Cystic Fibrosis meeting in Baltimore. ...