Phase III results for Arikace (Insmed) v. Tobi in Cystic Fibrosis infections

Insmed reports that its Phase III study of once-daily Arikace to treat Pseudomonas aeruginosa (Pa) in Cystic Fibrosis patients conducted at 70 sites in Europe and Canada met its primary endpoint of non-inferiority compared with twice-daily Tobi (tobramycin inhalation solution) for relative change in forced expiratory volume in one second (FEV1), measured at the end of the third treatment cycle (24 weeks) as compared to baseline.

Over the course of the study, patients treated with Arikace performed numerically worse on lung function tests compared to Tobi-treated patients, but the difference in efficacy between the two antibiotics was narrow enough to be considered equivalent statistically, Insmed said. More Arikace-treated patients reported adverse events in the study compared to patients treated with Tobi. Eleven Arikace patients reported severe side effects compared to six patients on Tobi.