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Bayer/Nektar experimental inhaled antibiotic fails in Phase III

Bayer and Nektar Therapeutics’ experimental inhaled antibiotic has failed to hit key targets assessing its effect on survival in patients with Gram-negative pneumonia.
The Phase III trial investigating Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients failed to demonstrate superiority versus standard of care and aerosolised placebo.
The primary outcome measure was survival at day 28-32. Secondary outcome measures included pneumonia-related mortality through to day 28-32, early clinical response up to day 10, number of days on mechanical ventilation up to day 28-32, and number of intensive care unit days up to day 28-32.
Amikacin Inhale combines a specially formulated Amikacin Inhalation Solution with Nektar Therapeutics’ proprietary Synchronized Inhalation System with a vibrating mesh nebulizer.
The companies signed a deal to work together on developing the inhaled antibiotic back in 2007.