Bayer Says INHALE Did Not Demonstrate Superiority

(RTTNews) - German conglomerate Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L) said Friday 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.

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 (ICU) days up to day 28-32.

The Amikacin Inhale program is being developed through a collaboration with Nektar Therapeutics (NKTR).