Insmed Announces First Patient Dosed In Pivotal European Phase 3 Clinical Study Of ARIKACE® In Cystic Fibrosis Patients With Pseudomonas Lung Infections

MONMOUTH JUNCTION, N.J., April 16, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced the initiation of the Company's CLinical Evaluation of ARIKACE phase 3 study (CLEAR-108) of ARIKACE® (liposomal amikacin for inhalation) in Europe for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections.

"The initiation of this clinical trial represents an important milestone for Insmed as we advance our ARIKACE program," said Timothy Whitten, President and CEO of Insmed.  "Even with currently available treatments, chronic Pa lung infections remain a significant medical issue for CF patients, and we believe ARIKACE has the potential to be an important treatment option for these patients.  In our randomized, placebo controlled phase 2 clinical study, ARIKACE demonstrated statistically significant improvement in lung function over the course of one complete 28-day on-treatment and 28-day off-treatment cycle in CF patients with Pa lung infections.  Our goal is to confirm the benefits of ARIKACE in this phase 3 trial."

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) (inhaled tobramycin solution), which is a commercially available inhaled antibiotic that is delivered twice daily.  The Company anticipates that the study will be conducted in approximately 300 patients.  The primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (about six months).  A key secondary endpoint will be time to pulmonary exacerbation. 

The study design was previously agreed upon by Insmed and the European Medicines Agency. Eligible patients will have the option to participate in a longer term open-label safety study, called CLEAR-110.  The study's Principal Investigator is Diana Bilton, M.D., Director of Adult CF Centre at the Royal Brompton Hospital in London, England. 

Top-line data from CLEAR-108 are currently expected to be available in the second half of 2013.

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