Insmed announced that it is proceeding with a Phase 2 clinical trial of Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease.
The Phase 2 clinical trial for Arikace in NTM patients will consist of a randomized, placebo-controlled study of approximately 100 adult patients with recalcitrant NTM lung disease. Patients who are NTM culture positive will continue with their antibiotic treatment regimen, and receive additionally either Arikace 560mg, delivered once daily via an optimized, investigational eFlow Nebulizer System (PARI Pharma GmbH), or placebo once daily. The primary efficacy endpoint will be change in mycobacterial density from baseline to the end of 84 days of treatment.
At the conclusion of the randomized portion of the study, eligible patients will receive Arikace 560mg once daily for an additional 84 days in an open-label design, primarily to measure longer-term safety and efficacy. The clinical trial design was previously agreed upon by Insmed and the FDA. The company expects to begin enrolling patients in the Phase 2 clinical trial in mid-2012.
Arikace is a formulation of the antibiotic amikacin, enclosed in nanocapsules of lipid called liposomes and delivered by the eFlow Nebulizer System. This formulation is designed to prolong the release of amikacin in the lungs while minimizing systemic exposure.
For more information, call (732) 438-9434 or visit www.insmed.com.