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Insmed's CEO Discusses Q2 2012 Results - Earnings Call Transcript

Moving on to non-TB mycobacteria, or NTM. Interest from potential participants in our TARGET-NTM Phase 2 clinical trials recalcitrant in or resistant patients has been strong, and we are well underway; we’re screening patients for this study.

As previously announced, we dosed our first patient in TARGET-NTM in June and plan to include about 100 patients in the trial. To-date, we have selected approximately 18 sites to participate in the study, and many of them are actively recruiting patients.

NTM lung infections often cause severe chronic debilitating and progressive lung disease, and can produce significant lung damage if not effectively treated. Unfortunately, current treatment options for these patients are sorely lacking. NTM lung infections are a growing health problem. Based on recent market research, we estimate there are about 50,000 patients in the U.S. with NTM lung infections, and about 40,000 of those have either non-TB mycobacteria avium complex or non-TB mycobacteria abscessus, which are the two pathogens included in the TARGET-NTM study.

The prevalence of these infections is growing rapidly, a study conducted by the National Institutes of Health on the prevalence of NTM lung disease was published just this past April in the American Journal of Respiratory Critical Care Medicine, this paper based on data from the Medicare database, showed NTM lung infections were growing at over 8% annually.

If ARIKACE is shown to be effective in treating these infections, they could prove to be a substantial advancement in the treatment of this chronic progressive debilitating disease. We remain on track to achieve top line results from the randomized portion of the study in the fourth quarter of 2013. In addition to the ARIKACE clinical program, we’re conducting a nine-month dog inhalation toxicity study of ARIKACE, which started in late April.

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