CURx Pharmaceuticals, a San Diego-based developer of late-stage therapeutics with high medical need, has entered into a global license agreement with Gilead Sciences for development of Fosfomycin:Tobramycin for Inhalation (FTI) to treat Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. FTI is ready for phase III clinical trials, having successfully completed a phase II trial in CF patients.
Dinu Sen, CEO and founder of CURx, said, "Clinical trials in CF patients with Pseudomonas aeruginosa infection have demonstrated FTI's safety and efficacy. Future trials may pave the way for its use against a range of bacterial infections in CF—there is an unmet need for antibiotics with such characteristics."
"Lung infections continue to be a serious problem for individuals with cystic fibrosis," said Dr. Drucy Borowitz, director of the Cystic Fibrosis Center of Western New York. "If further studies confirm that (FTI) is safe and efficacious, it will be a significant addition to improving the health of people with CF."
Dr. Patrick Flume, director of the Cystic Fibrosis Center at Medical University of South Carolina, said, "Currently we have two drugs approved in the U.S. for use in CF patients, but there remains a need for more options.”
FTI is a combination of fosfomycin and tobramycin, antibiotics well characterized for safety and anti-bacterial activity. FTI is formulated as a liquid for inhalation with an aerosol device. In phase II clinical trials FTI was shown to be safe and to effectively maintain improvement in lung function achieved with Cayston in CF patients with Pseudomonas aeruginosa infection. FTI has demonstrated antibiotic activity against multiple pathogenic bacteria, including methicillin-resistant Staphylococcus aureus(MRSA), in preclinical studies.