Bayer HealthCare has announced the initiation of its Phase 3 program to evaluate the efficacy and safety of Amikacin Inhale in patients with Gram-negative pneumonia who are intubated and mechanically ventilated and being treated with intravenous antibiotics. Bayer is developing Amikacin Inhale in partnership with Nektar, and the inhalation solution is delivered by Nektar’s Pulmonary Drug Delivery System (PDDS).
The two randomized, double-blind, placebo-controlled studies will involve about 1,300 patients in multiple countries.
Bayer Executive Committee Member and Head of Global Development Kemal Malik said, “The Phase 3 program will provide significant insight and knowledge into this promising concept. We hope that Amikacin Inhale will provide physicians with a new treatment option for treating Gram-negative pneumonia in this vulnerable patient population.”
Read the Bayer Healthcare press release.
