( d Spain Introduction: IV ami...)Nektar Threraputics Announces Phase 2a Clinical Results Regarding,the use of NKTR-061 (Inhaled Amikacin) to Treat Gram-Negative,Hospital-Acquired Pneumonia Presented at the Annual American,Thoracic Society International Conference,Health

d, Spain Introduction: IV amikacin therapy is monitored to maintain peak serum concentrations below 35 ug/mL and trough levels below 10ug/mL to avoid toxicity. Aerosolized amikacin (AMK) has been reported to achieve high lung concentrations with low serum levels. Objective: Evaluate the safety of aerosol-delivered (AMK) in order to achieve high lung concentrations and low serum concentration. Patients and Methods: A double-blind, placebo-controlled, study of aerosol AMK delivered via the Pulmonary Drug Delivery System (PDDS, Nektar Therapeutics) in ventilated patients with gram-negative pneumonia as an adjunctive to IV therapy per ATS guidelines was conducted. Patients were randomized to receive aerosol containing 400 mg AMK QD with placebo (ns) 12h later; 400 mg AMK BID or placebo BID. Peak AMK concentration was determined in serum collected .25, 1, 2, and 4 h after delivery of the AM dose on days 1 and 3 and used to calculate Cmax. Trough concentrations were determined daily 30 minutes prior to the AM dose. Results: For QD vs BID groups, serum Cmax was 1.3 vs 2.3 ug/mL (respectively) on day 1, and 2.3 vs 3.2 ug/mL on day 3, with mean trough levels of 0.87 vs 1.49 ug/mL. The mean duration of aerosol AMK treatment was 7 days. Aerosol AMK was well tolerated and there was no difference in adverse events across treatment groups. Conclusion: Delivery of aerosolized AMK achieves safe serum concentrations using the PDDS, vibrating mesh nebulizer. The clinical impact of adjunctive aerosol therapy remains to be determined.

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