Insmed Announces Presentations at the American Thoracic Society 2018 International Conference
- Data 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)
- Improvements in Six Minute Walk Test (6MWT) observed for converters vs. non-converters
- Preliminary results of an investigator initiated ongoing Phase 2 trial studying ALIS in lung disease caused by M. Abscessus (MAB), demonstrating 30% of patients receiving ALIS met culture conversion criteria
- Regulatory review in the
U.S.currently underway with PDUFA action date set for September 28, 2018
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 (p < 0.0001). 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
The ATS abstracts are available online on Insmed's website, www.insmed.com.
About NTM Lung Disease
NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. There is an increasing prevalence of lung disease caused by NTM and
The prevalence of human disease attributable to NTM has increased over the past two decades. In a decade long study (1997 to 2007), researchers found that the
prevalence of NTM lung disease in the
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. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function.
About CONVERT (INS-212) and INS-312
CONVERT is a randomized, open-label, global Phase 3 trial designed to confirm the culture conversion results seen in
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