Bayer's Amikacin Inhale misses in Phase III for Gram-negative pneumonia
Bayer AG (Xetra:BAYN) reported data from the double-blind, international Phase III INHALE program in 725 intubated and mechanically-ventilated patients with Gram-negative pneumonia showing that Amikacin Inhale (BAY41-6551, NKTR-061) plus standard of care (SOC) missed the primary endpoint of improving survival at day 28-32 vs. placebo plus SOC. Amikacin Inhale plus SOC also missed the secondary endpoints of improving 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 (ICU) days up to day 28-32 vs. placebo plus SOC.
Patients received SOC IV antibiotics plus placebo or 400 mg Amikacin Inhale every 12 hours for 10 days...
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