SAN DIEGO -- CURx Pharmaceuticals today announced it 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 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 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.
About cystic fibrosis
Cystic fibrosis is a hereditary disease affecting the lungs and digestive system of 30,000 children and adults in the US and 70,000 worldwide. Chronic bacterial infections in the lungs of CF patients are common and can be life threatening if not adequately treated. Pseudomonas aeruginosa infects the lungs of half of all CF patients, while methicillin-resistantStaphylococcus aureus (MRSA) infects the lungs of about a quarter of CF patients.
About CURx Pharmaceuticals
San Diego-based CURx Pharmaceuticals specializes in developing late-stage therapeutics with high medical need. In August 2013 CURx Pharmaceuticals licensed intravenous topiramate from Ligand Pharmaceuticals, Inc. for treatment of hospitalized epilepsy patients unable to take oral medication. Please visit www.curxpharma.com for more information.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA and other foreign review processes and other governmental regulation, CURx Pharmaceuticals' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors. CURx Pharmaceuticals undertakes no duty to update forward-looking statements.