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March 26, 2014
07:02 EDTINSMInsmed says ARIKAYCE did not achieve primary endpoint in Phase 2 trial
Insmed Incorporated reported 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. The randomized, double-blind, placebo-controlled phase 2 clinical trial compared ARIKAYCE, added to standard of care treatment, versus standard of care treatment plus placebo, in 90 adult patients with treatment resistant NTM lung disease. Eligibility for the study required patients to have been on the American Thoracic Society/Infectious Disease Society of America guideline therapy for at least six months prior to screening and to continue to have persistently positive mycobacterial cultures. The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the trial. ARIKAYCE did not meet the pre-specified level for statistical significance although there was a positive trend in favor of ARIKAYCE. However, ARIKAYCE did achieve statistical significance with regard to the clinically relevant key secondary endpoint of culture conversion, with 11 out of 44 patients treated with ARIKAYCE demonstrating negative cultures by day 84 of the study as compared to 3 out of 45 patients treated with placebo. Patients receiving ARIKAYCE experienced a greater number of adverse events than those receiving placebo. All adverse events experienced with ARIKAYCE were consistent with those seen in similar patient populations receiving inhaled antibiotics. The most common side effect was laryngeal irritation. The company plans to incorporate these results into discussions with the regulatory agencies in the United States and Europe to determine next steps for ARIKAYCE. The company also intends to apply for Breakthrough Therapy Designation for ARIKAYCE in the United States based upon the culture conversion results. ;.
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