In the 725-patient Inhale trial, Bayer’s Amikacin Inhale did not out-perform a placebo as a treatment for Gram-negative pneumonia in patients on ventilators.
The vibrating mesh nebulizer is designed to deliver amikacin at levels that are much higher than systemic delivery. But the Inhale trial showed that adding Amikacin Inhale to a standard antibiotic regimen used to treat Gram-negative pneumonia did not boost overall survival after 28 days compared to the control group.
The drug-device product also failed to improve the number of days that patients spent on mechanical ventilation.
“The results of the Inhale study are disappointing, considering that morbidity and mortality remain significant in these patients. However, the study provides important clinical data for this difficult-to-treat disease,” Bayer’s head of development, Dr. Joerg Moeller, said in prepared remarks.