Fosfomycin/Tobramycin Inhalation Solution for Cystic Fibrosis (CF) Lung Infections

Fosfomycin/tobramycin inhalation solution (FTI) is a combination antibiotic therapy consisting of fosfomycin and tobramycin (ratio 4:1). FTI has shown improved effectiveness against lung infections caused by bacteria compared to fosfomycin or tobramycin alone. The investigative therapy is used to treat lung infections in patients with cystic fibrosis (CF).

How fosfomycin/tobramycin works

FTI is a broad spectrum antibiotic for the treatment of CF lung infections that consists of fosfomycin, an antibiotic with activity against both gram-positive and gram-negative bacteria, and tobramycin, an aminoglycoside that has potent gram-negative activity.

FTI rapidly kills a variety of gram-positive and gram-negative bacteria commonly present in people with CF experiencing lung infections, and demonstrates effectiveness in killing bacteria relative to fosfomycin and tobramycin alone.

FTI also shows a low frequency of resistance relative to fosfomycin and tobramycin alone.

FTI studies

A Phase 2 clinical trial was carried out by Gilead (NCT00794586) regarding the use of FTI in people with CF with Pseudomonas aeruginosa lung infection. FTI maintained substantial improvements in FEV1 (a measure of lung function) achieved during a 28-day open-label, run-in course of aztreonam for inhalation (AZLI) and was well tolerated.

Gilead licensed FTI to CURx, which is now initiating all activities required for a Phase 3 study that will begin in 2017 to test the safety and effectiveness of the combo therapy, as well as all the product registration needs for FDA review.

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