In addition, the company is also planning European registration Phase 3 clinical trial of Arikace in Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections.
The randomized placebo-controlled Phase 2 clinical trial of Arikace will include around 100 adult patients with recalcitrant NTM lung disease.
In the study, patients will receive either Arikace 560 mg once-daily, delivered via Pari Pharma’s eFlow nebulizer system or placebo.
The primary objective will be change in mycobacterial density from baseline to the end of 84 days of treatment.
The company plans to commence enrolling patients in the Phase 2 clinical trial in mid-2012.
The European study in 300 CF patients with Pa lung infections will be a randomized Phase 3 trial comparing Arikace 560 mg to Tobi (inhaled tobramycin solution).
In the European study, 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, while secondary endpoint will be time to pulmonary exacerbation.
Insmed intends to initiate enrolling patients in the Phase 3 European clinical study in the Q2 2012.