CURx Pharmaceuticals, a specialised company in developing late-stage therapeutics with high medical need, has entered into a global license agreement with Gilead Sciences, Inc. 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.
"This is a great acquisition for CURx Pharmaceuticals which enables us to expand our portfolio and also to provide another inhaled therapeutic to the cystic fibrosis community," commented Dinu Sen, CEO and founder of CURx. "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," commented Dr Drucy Borowitz, director of the Cystic Fibrosis Centre 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 Centre at Medical University of South Carolina added, "Currently we have two drugs approved in the US for use in CF patients, but there remains a need for more options. The CF community welcomes the development of new treatment options such as FTI."
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.
CURx Pharmaceuticals specializes in developing late-stage therapeutics with high medical need.