Data presented at ATS 2018 support the benefit of treating patients with a combination of ALIS (Amikacin Liposome Inhalation Suspension) and guideline-based therapy (GBT) for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
ALIS is a novel, inhaled, once-daily formulation of amikacin that is in late-stage clinical development for adult patients with treatment-refractory NTM lung disease caused by MAC.
Results from 336 randomized patients in the Phase 3 CONVERT study cumulatively demonstrated that ALIS, combined with GBT, improved culture conversion rates. The global CONVERT study met its primary endpoint of culture conversion by Month 6 with statistical significance.
In the study, the addition of ALIS to GBT 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. Additionally, results from an exploratory analysis using the 6MWT, a quality of life measure, demonstrated that converters from both groups (ALIS + GBT and GBT alone) saw a mean increase in distance walked at Month 6 of 16.8 meters as compared to baseline (p=0.011).
“The data presented at ATS underscore the positive impact that treatment with ALIS in combination with GBT can have in just six months treating patients with this rare, progressive and potentially fatal disease,” remarked Will Lewis, President and Chief Executive Officer of Insmed. “The improvement observed in the 6MWT suggest that eradication of NTM caused by MAC may provide a benefit in physical function for these patients.”