Bayer has announced the failure of the Phase 3 INHALE study of Amikacin Inhale inhalation solution for the treatment of gram-negative pneumonia in intubated and mechanically ventilated patients with Gram-negative pneumonia to demonstrate superiority in an inhaled placebo and therefore the failure of the study to meet either its primary or secondary endpoints.
Bayer is partnered with Nektar on development of Amikacin Inhale, which is also known as BAY 41-6551 or NKTR-061.
The company announced the initiation of the INHALE study in April 2014, saying that if planned to enroll approximately 1,300 patients. According to the results announcement, the study enrolled 725 patients who received standard of care IV antibiotics plus either 400 mgs of Amikacin Inhale every 12 hours for 10 days via the Synchronized Inhalation System or aerosolized placebo every 12 hours for 10 days via the Synchronized Inhalation System.
The primary endpoint was survival at day 28-32, with secondary endpoints including pneumonia-related mortality, days on mechanical ventilation, and days in intensive care through day 28-32.
Amikacin Inhale received QIDP designation from the FDA in 2014 along with Bayer’s inhaled ciprofloxacin. The FDA’s Antimicrobial Drugs Advisory Committee recently voted against recommending approval of Bayer’s NDA for inhaled ciprofloxacin DPI for the reduction of exacerbations in non-cystic fibrosis bronchiectasis patients with bacterial lung infections.
Read the Bayer press release.