Arikace: Phase III data

The open-label, European and Canadian Phase III CLEAR-108 trial in 302 CF patients with chronic P. aeruginosa infection showed that once-daily 560 mg Arikace met the primary endpoint of non-inferiority to twice-daily 300 mg TOBI tobramycin inhalation solution in the mean relative change from baseline in FEV1 at day 168 (p=0.4809). The non-inferiority margin was 5%. However, the mean relative improvement in FEV1 was numerically lower for Arikace compared to TOBI. Insmed also said that secondary endpoint data were comparable to that of the primary endpoint, including data for the mean change in P. aeruginosa sputum density (p=0.1239). There was no difference in serious adverse events between treatment arms. Each cycle of Arikace treatment consisted of once-daily 560 mg Arikace administered with the eFlow Nebulizer System from Pari GmbH (Starnberg, Germany) for 28 days followed by 28 days off-treatment. About 75% of patients in the trial are enrolling in a 2-year, open-label safety extension study. In 1H14, Insmed plans to submit regulatory applications to EMA and Health Canada for Arikace to treat P. aeruginosa infection in CF patients. ...