Bayer drug-device combo for pneumonia flunks phase III test

Bayer’s inhaled version of the antibiotic Amikacin - using a new delivery system specifically designed for patients on ventilators - has missed the mark in late-stage trials.

It’s the second disappointment for Bayer and device partner Nektar Therapeutics in a matter of days. The two companies have also collaborated on Cipro Inhale, a drug-device combination based on ciprofloxacin that was rejected by a US FDA advisory committee last week as a treatment to reduce exacerbations in adults with non-cystic fibrosis bronchiectasis and bacterial respiratory pathogens.

The INHALE programme - which consisted of two trials - found that the Amikacin Inhale drug device combination (NKTR-061) didn’t provide any additional benefit over standard antibiotic care for Gram-negative pneumonia in intubated and mechanically ventilated patients when compared to placebo. The primary outcome measure - overall survival at 28 days - was the same in both the treatment and control arms.

Gram-negative pneumonias often result from complications of other patient conditions or surgeries, and account for up to 85% of hospital-acquired pneumonias - especially prevalent in intensive care units - where they are associated with significant morbidity and mortality.

“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,” commented Bayer’s head of development Joerg Moeller.

Amikacin Inhale combines the aminoglycoside antibiotic with a specialised device - including a vibrating mesh nebulizer - that can be integrated into mechanical ventilation units or used as a hand-held device for patents who no longer need breathing assistance.

In phase II trials, Amikacin Inhale achieved over 1,000 times greater lung exposure to the antibiotic amikacin compared to standard intravenous administration, raising the hope that it could improve bacterial eradication and improve survival.

Shares in Nektar were down a little over 6% in after-hours trading after news of the trial failure broke during the Thanksgiving holiday.