Insmed announces 'positive' results from Phase 2 ARIKAYCE study
Insmed announced additional results from the Company’s phase 2 clinical trial of ARIKAYCE, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant nontuberculous mycobacterial lung infections. At the conclusion of the 84-day double blind phase of the trial, 78 of the 80 patients agreed to receive once-daily ARIKAYCE plus standard of care treatment for an additional 84 days. Data from 68 of these patients who completed the visits during the additional open label phase were available for inclusion in the poster. These results collected from the open label phase show that 21 of these patients were culture negative for NTM at Day 168. This data reflects 10 patients who were culture negative at Day 84 as well #$%$ additional patients from the ARIKAYCE arm and 6 additional patients who were on placebo, switching to ARIKAYCE during the open-label phase. The number of patients with negative cultures increased from the double blind phase of the trial in which 11 out of 44 patients treated with ARIKAYCE demonstrated negative cultures by day 84 of the study as compared to 3 out of 45 patients treated with standard of care plus placebo.