Insmed jumps on Phase III success in rare lung infection

Insmed Inc. (NASDAQ:INSM) soared $14.70 (120%) to $26.99 on Tuesday and ended the day with about $1.7 billion in market cap after reporting that ALIS (amikacin liposome inhalation suspension, Arikayce) met the primary endpoint of culture conversion by month six in the Phase III CONVERT trial for treatment-refractory non-tuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC), a condition for which there are no approved treatments. On a conference call, CEO William Lewis said the company will provide guidance on a timeline for submitting an NDA seeking accelerated approval of ALIS “in the future.”

The trial enrolled 336 patients who were refractory to at least six months of guideline-based therapy (GBT) to receive once-daily ALIS plus GBT or continue receiving GBT alone. ALIS plus GBT eliminated evidence of NTM lung disease caused by MAC in sputum in 29% of patients by month six vs. 9% of patients who received GBT alone (p<0.0001). ALIS plus GBT also met the secondary endpoint of reducing time to conversion (p<0.0001), but missed the secondary endpoint of improving six-minute walk distance (6MWD) vs. GBT alone. The GBT used in the trial was based on guidelines from the Infectious Diseases Society of America and the American Thoracic Society...