Abstract
SLITTM Amikacin is a sustained-release lipid formulation of amikacin for inhalation, being developed for the treatment of P. aeruginosa (Pa) infections in CF patients. A Phase Ia/IIb clinical study was conducted with a total of 13 patients treated for 14 days with 500mg qd SLIT Amikacin by nebulization. Patients were naive to inhaled antibiotics. Pseudomonas isolates at screening had amikacin minimum inhibitory concentration (MIC) values of 16 ug/mL. The drug was safe and well tolerated with no nephrotoxicity to date. Systemic exposure to SLIT Amikacin was very low. Final data analysis showed clinically relevant improvement in FEV1 and a decreased bacterial density. The absolute change (mean) in FEV-1 liters at days 14 (post last dose), 28 and 42 (28 day follow-up) were 0.26, 0.24 and 0.31. There appeared to be a trend for decreased CFUs that correlated with improvements in FEV-1. The results demonstrate once a day treatment with nebulized SLIT Amikacin is safe and elicits a clinically relevant effect on pulmonary function and Pa density of CF patients.
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