amikacin inhalation solution (NKTR-061) / Nektar Therap - LARVOL DELTA

Inhaled amikacin in association with systemic meropenem reduces proximal airways bacterial burden and hinders antibiotic resistance in a swine model of monolateral MDR Pseudomonas aeruginosa pneumonia (ECCMID 2019) - "In a swine model of monolateral MDR P. aeruginosa pneumonia, the use of inhaled amikacin as adjuvant treatment improves only proximal airways bacterial eradication and hinders antibiotic resistance. Grant Acknowledgment: BayerAG,Germany"

Anesthesia • Infectious Disease • Pneumonia • Respiratory Diseases

Effect of inhaled amikacin within endotracheal tubes biofilm from pigs with severe Pseudomonas aeruginosa pneumonia (ECCMID 2019) - "Materials/ Eighteen ETT were obtained from pigs challenged with a PA (45 ml of 107 cfu/ml), resistant to amikacin (MIC>32 mg/L) and susceptible to meropenem (MIC=0.5 mg/L), mechanically ventilated for 102h. PA burden (Log CFU/ml) before treatment initiation was similar among IAMK+ IV-MERO, CONTROL and IV-MERO groups in tracheal aspirate (5.73 [5.31-6.42], 5.51 [4.62-6.47], 6.46 [4.24-6.59], p=0.558, respectively) and in bronchoalveolar lavage (4.08 [3.81-4.87], 4.34 [3.44-4.86], 3.65 [2.72-4.44], p=0.404, respectively). Differences were found among groups in PA ETT biofilm burden (p=0.039). Specifically, the lowest PA burden was found in IAMK+ IV-MERO (0.00 [0.00-2.13]) versus CONTROL (6.04 [4.36-6.72]) and vs IV-MERO (3.69 [1.63-6.87]) groups, p=0.014 and p=0.068, respectively."

Infectious Disease • Pneumonia • Respiratory Diseases

INHALE 1: Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (clinicaltrials.gov) - P3; N=725; Completed; Sponsor: Bayer; N=264 ➔ 725

Enrollment change • Biosimilar

Pharmacodynamics of inhaled amikacin (BAY 41-6551) studied in an in vitro pharmacokinetic model of infection. (PubMed, J Antimicrob Chemother) - "If MIC values were related to bacterial clearance then at least a static effect or -1 log drop in count would be expected for bacterial strains with MICs of ≤180 mg/L (static effect) or ≤148 mg/L (-1 log drop effect). An fAUC/MIC amikacin target of 50-80 is appropriate for aerobic Gram-negative bacilli and mean ELF concentrations of BAY 41-6551 would produce a static to -1 log clearance with strains up to 128 mg/L."

Journal • PK/PD data • Preclinical