Insmed Announces CLEAR-108 Phase 3 Clinical Study of ARIKACE® in Cystic Fibrosis Patients with Pseudomonas Lung Infections Has Completed Target Enrollment
MONMOUTH JUNCTION, N.J., Nov. 13, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company focused on developing inhaled therapeutics for serious diseases of the lung, today announced that the Company's CLinical Evaluation of ARIKACE (CLEAR-108) phase 3 European and Canadian registrational study of ARIKACE® (liposomal amikacin for inhalation) for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections has now enrolled over 300 patients.
CLEAR-108 is a randomized, phase 3 trial comparing ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH), to TOBI® (1) (tobramycin solution for inhalation), which is a commercially available inhaled antibiotic that is delivered twice daily. The study is being conducted in over 300 patients in Europe and Canada.
"The completion of enrollment in this pivotal phase 3 clinical trial represents an important milestone for Insmed as we advance ARIKACE closer to commercialization," said Will Lewis, President and CEO of Insmed. "We continue to expect top-line data from CLEAR-108 to be available in mid-2013."