Gilead Sciences, Inc. was recently in the news with regard to the drug maker’s Hepatitis C cure, and how developing countries such as India are lobbying for Gilead to lower its prices so that lower-income patents can gain access to the treatment. Now, Gilead has made headlines in the field of cystic fibrosis therapy, forging a major licensing agreement with CURx Pharmaceuticals.
CURx is a specialty drug development company that focuses on creating late-stage therapeutics that meet high medical needs, such as CF, which, in spite of major therapeutic advances over the past decades, is a still a deadly disease with no cure and few viable treatments. In a recent press release, Gilead and CURx announced a global license agreement for development of Fosfomycin Tobramycin for Inhalation (FTI) to treat Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. The drug is slated to enter into phase III clinical trials soon, after positive phase II results.
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Dinu Sen, CEO and founder of CURx, commented on how the addition of Gilead’s cystic fibrosis treatment will bolster the company’s therapeutic offerings: “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,” he 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.”
Currently, there appears to be a high degree of optimism about FTI and what it may mean for the future of CF treatment, with cystic fibrosis experts and leaders weighing in on its potential benefits. “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 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.”
The reason for the optimism is that “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.” Because the infections that come as a result of congestion in the lungs of CF patients, the need for an effective antibiotic that can curtail the spread of serious infection could eventually increase lifespan and quality of life for thousands of people who currently have the disease.