Gilead's CF drug positive in Ph III trial

California, USA-based biopharmaceutical company Gilead Sciences says that its developmental cystic fibrosis treatment, aztreonam lysine, has achieved primary efficacy goals in a Phase III study. Specifically, the drug, which is being used as a therapy for CF patients infected with Pseudomonas aeruginosa, brought about a significant improvement in respiratory symptoms, according to a patient-reported survey of outcome measures.

The trial, known as AIR-CF1, is part of a program of three assessments designed to determine the drug's safety and efficacy. During the study, which enrolled 164 patients, participants were provided with an initial course of tobramycin inhalation solution followed by treatment with 75mg aztreonam lysine, or placebo, twice or three times a day for 28 days.

The results showed that treated patients achieved a mean 9.7 point improvement in symptoms on the CFQ-R (Cystic Fibrosis Questionairre-Revised) scale, compared with placebo. In addition, those that received the drug also showed significant improvement, equivalent to a 10.3 point improvement from baseline, in respiratory function at day 28.