Insmed Announces The Completion Of Patient Enrollment In ARIKACE Phase 2 Study

(RTTNews) - Insmed Inc. (INSM), a biopharmaceutical company focused on lung diseases, Tuesday announced that it has completed patient enrollment in its Phase 2 clinical study of ARIKACE, or liposomal amikacin for inhalation for patients with recalcitrant nontuberculous mycobacterial or NTM lung disease in the U.S. and Canada.

The primary efficacy endpoint in the study is the semi-quantitative measurement of the change in mycobacterial density. Certain secondary, tertiary and exploratory endpoints being measured include, but are not limited to, time to sputum conversion, change in clinical signs and symptoms, change in patient related outcomes/quality of life and safety.

The company noted that ARIKACE has received Orphan Drug, Qualified Infectious Disease Product or QIDP and Fast Track designations from the U.S. Food and Drug Administration or FDA for the treatment of NTM lung infections.

Separately, Insmed announced that it commenced the Scientific Advice Working Party process with the European Medicines Agency or EMA and expects to have discussions with the EMA regarding ARIKACE for NTM lung disease during the fourth quarter of 2013.

The company added that it is in the process of evaluating other international markets, such as Japan, where NTM lung infections are already a significant and growing unmet medical need.

Insmed said it is actively developing a strategy for more broadly commercializing ARIKACE in this globally uncontested orphan disease market.