Insmed has dosed first Cystic Fibrosis (CF) patient in the Clinical Evaluation of ARIKACE (CLEAR-108) phase 3 study of Arikace (liposomal amikacin for inhalation) in Europe.
CLEAR-108 is a 300-patient randomized phase 3 trial comparing Arikace 560mg, delivered once daily via PARI Pharma's eFlow nebulizer system to Tobi (inhaled tobramycin solution).
The eFlow nebulizer system uses eFlow Technology to enable highly efficient aerosolization of medication and to reduce the burden of taking daily, inhaled treatments.
The study's primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles, while the secondary endpoint will be time to pulmonary exacerbation.
Insmed president and CEO Timothy Whitten said in the randomized placebo controlled phase 2 clinical study, Arikace demonstrated improvement in lung function over the course of one complete 28-day on-treatment and 28-day off-treatment cycle in CF patients with Pseudomonas aeruginosa lung infections.
"Our goal is to confirm the benefits of ARIKACE in this phase 3 trial," Whitten added.
Eligible patients will have the option to participate in a longer term open-label safety study, called CLEAR-110, the company said.
The findings from the CLEAR-108 are expected to be available in the second half of 2013.
