Bayer has reported results from a Phase III clinical trial programme (INHALE) of Amikacin Inhale and standard-of-care IV antibiotics combination evaluated in intubated and mechanically ventilated patients with gram-negative pneumonia.
Amikacin Inhale is an investigational drug-device combination, involving Amikacin Inhalation Solution and Nektar Therapeutics' Synchronised Inhalation System with a vibrating mesh nebuliser.
The trial has failed to meet the primary endpoint of superiority, as well as secondary endpoints.
Performed in 725 subjects, the multi-national, randomised, placebo-controlled, double-blind, multi-centre Phase III programme assessed the safety and clinical efficacy of the combination.
Subjects were administered with 400mg Amikacin Inhale or aerosolised placebo every 12 hours for 10 days using the Synchronised Inhalation System.
Both groups were given standard of care IV antibiotics.
Bayer Medical Affairs vice-president Aleksandra Vlajnic said: "New treatment options are needed for difficult-to-treat Gram-negative pneumonia in intubated and mechanically ventilated patients in the intensive care unit setting, as morbidity and mortality remain significant in these patients.”
The primary outcome measure of the trial was survival at day 28-32, while the secondary outcome measures were pneumonia-related mortality, number of days on mechanical ventilation and intensive care unit (ICU) days up to day 28-32, as well as early clinical response up to day ten.
Bayer is conducting the Phase III INHALE programme of Amikacin Inhale in partnership with Nektar Therapeutics for the treatment of adult, intubated and mechanically ventilated patients with gram-negative pneumonia.