CURx Pharmaceuticals will team up with Gilead Sciences in developing its broad spectrum combination antibiotic Fosfomycin:Tobramycin for Inhalation (FTI) to treat a form of lung infection in cystic fibrosis (CF) patients, under a global license agreement whose value was not disclosed.
FTI (formerly known as GS 9310/11) is a combination of the antibiotics fosfomycin, an antibiotic with activity against gram-positive and gram-negative bacteria, and tobramycin, an aminoglycoside antibiotic with potent gram-negative activity. FTI is designed for treatment of patients with CF, formulated as a liquid for inhalation with an aerosol device.
According to CURx, FTI is ready to enter Phase III clinical trials to assess the compound treatment for Pseudomonas aeruginosa lung infection in patients with CF, following successful completion a Phase II trial in CF patients last year by Gilead.
In Phase II, 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.
Pseudomonas aeruginosa infects the lungs of half of all CF patients, while MRSA infects the lungs of about a quarter of CF patients.
“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,” Dinu Sen, CEO and founder of CURx, said in a statement. “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.”
Patrick Flume, director of the Cystic Fibrosis Center at Medical University of South Carolina, said the CF community welcomed an alternative to the two U.S.-approved treatments now available for people with the disease: “If further studies confirm that (FTI) is safe and efficacious it will be a significant addition to improving the health of people with CF.”