NKTR:
A little nick in the armor this morning. Seems contained...
Phase III study with Amikacin Inhale in intubated and mechanically ventilated patients with Gram-negative pneumonia does not meet primary endpoint of superiority
PR Newswire PR NewswireNovember 24, 2017Comment
WHIPPANY, N.J., Nov. 24, 2017 /PRNewswire/ -- Bayer today announced that INHALE, a global Phase III clinical study program investigating Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia, did not demonstrate superiority versus standard of care plus aerosolized placebo. The primary endpoint, as well as secondary endpoints were similar in both treatment arms, and were therefore not met. Amikacin Inhale is the development name of an integrated drug-device combination, consisting of a specially formulated Amikacin Inhalation Solution and a proprietary Synchronized Inhalation System with a vibrating mesh nebulizer.