BioCentury
ARTICLE | Clinical News

Insmed falls on Phase III data for lung infection compound

July 2, 2013 12:35 AM UTC

Insmed Inc. (NASDAQ:INSM) slid $2.24 (19%) to $9.72 on Monday after reporting data from the Phase III CLEAR-108 trial evaluating Arikace amikacin to treat Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients. Once-daily Arikace administered with the eFlow Nebulizer System from Pari GmbH (Starnberg, Germany) met the primary endpoint of non-inferiority to twice-daily TOBI tobramycin inhalation solution from Novartis AG (NYSE:NVS; SIX:NOVN) in the mean relative change from baseline in forced expiratory volume in 1 second (FEV1) at day 168 (p=0.4809). The non-inferiority margin was 5%. However, Insmed said the mean relative improvement in FEV1 was numerically lower for Arikace compared to TOBI. The open-label, European and Canadian trial enrolled 302 CF patients with chronic P. aeruginosa infection. ...