Insmed falls on Arikayce miss for non-TB lung infection

Insmed Inc. (NASDAQ:INSM) fell $2.39 (13%) to $15.90 on Wednesday after reporting that once-daily Arikayce amikacin plus standard of care (SOC) missed the primary endpoint vs. placebo plus SOC in 89 evaluable patients in the Phase II TARGET NTM (TR02-112) trial to treat treatment-resistant non-tuberculosis mycobacterial (NTM) lung infection. The primary endpoint was a reduction in mycobacterial density as measured by a seven-point scale from baseline to day 84. Arikayce plus SOC did meet the secondary endpoint of a greater proportion of patients with culture conversion to negative by day 84 vs. placebo plus SOC (25% vs. 7%, p=0.01). Additional data are slated to be presented at the American Thoracic Society meeting in May.

Insmed plans to meet with FDA and EMA to determine next steps for Arikayce in the indication, for which the product has Qualified Infectious Disease Product (QIDP) designation in the U.S. The company said it also plans to apply for breakthrough therapy designation in the U.S. based on the culture conversion data in TARGET NTM. ...