Insmed announces presentation of new data from ARISE study of ARIKAYCE

Insmed Incorporated announced that late-breaking data from the ARISE study of ARIKAYCE, a amikacin liposome inhalation suspension, were presented at the American Thoracic Society, or ATS, 2024 International Conference in San Diego. Data from ARISE evaluating patients with newly diagnosed or recurrent nontuberculous mycobacterial, or NTM, lung infection caused by Mycobacterium avium complex (MAC) who had not received antibiotics for their current infection were presented in an oral session and during the ATS Breaking News session “Clinical Trial Results in Pulmonary Medicine.” As previously announced, data from ARISE demonstrated that the Quality of Life-Bronchiectasis respiratory domain may be an effective patient-reported outcome (PRO) tool in patients with MAC lung disease. In ARISE, ARIKAYCE-treated patients performed better than those in the comparator arm as measured by the QOL-B instrument, with 43.8% of patients achieving an improvement in QOL-B respiratory score above or equal to the estimated meaningful within-subject score difference of 14.8, compared with 33.3% of patients in the comparator arm. While the study was not powered to show a statistically significant difference between treatment arms, a strong trend toward significance was observed for improvement from baseline at Month 7. New data presented showed that patients in the ARIKAYCE treatment arm experienced continued improvement in QOL-B scores to Month 7, which included one month off treatment. In contrast, in patients randomized to the comparator arm, QOL-B scores plateaued between Month 3 and Month 6 and worsened after stopping treatment at Month 6 through Month 7.