=Insmed (INSM): positive top-line results from Phase 3 CONVERT Study

• The new inhaled antibiotic shows signs of promise in the latest trial. 
• Insmed said it will use the proceeds of a $250 million IPO to get Alis ready for commercial sales.

Insmed announces positive top-line results from Phase 3 CONVERT Study of ALIS in Adult Patients with Treatment-Refractory Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium Avium Complex (MAC); met primary endpoint; Company plans to pursue accelerated approval and request priority review

• The global CONVERTstudy met its primary endpoint of culture conversion by Month 6 with statistical and clinical significance. The study demonstrated that the addition of ALIS to guideline-based therapy eliminated evidence of NTM lung disease caused by MAC in sputum by Month 6 in 29% of patients, compared to 9% of patients on GBT alone.
• The trial was powered to detect a treatment effect of 15% between the two treatment groups. The CONVERT study enrolled 336 adult patients with NTM lung disease caused by MAC who were refractory to at least six months of GBT. Patients were randomized 2:1 to receive ALIS plus GBT versus GBT alone. The primary endpoint was the proportion of patients achieving culture conversion by Month 6.
• Overall the rate of reported adverse events in the ALIS plus GBT arm was higher and these events were predominately mild or moderate in nature and generally declined after the second month of treatment. These findings are consistent with the Phase 2 study results and demonstrate adverse events similar to those seen in other clinical studies of inhaled antibiotics.