Insmed's mixed results from Ph II trial for treatment resistant NTM lung infections
US-based Insmed (Nasdaq GS: INSM) has reported mixed results from its Phase II clinical trial of Arikayce (liposomal amikacin for inhalation), for the treatment of patients with treatment resistant non-tuberculous mycobacterial (NTM) lung infections.
The randomized, double-blind, placebo-controlled trial compared Arikayce added to standard of care treatment, versus standard of care treatment plus placebo, in 90 adult patients with treatment resistant NTM lung disease. The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline (day one) to the end of the randomized portion of the trial (day 84). Arikayce did not meet the pre-specified level for statistical significance although there was a positive trend in favor of Arikayce.
Secondary endpoint provides good news
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