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CURx Pharma Joins Gilead to Develop FTI for a CF-Related Lung Infection

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

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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.”

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Related questions

01What to expect from your doctor

After getting detailed information about the symptoms and your family's medical history, your healthcare professional may order tests to help with diagnosis and plan treatment. Your healthcare professional also may ask questions, such as: What symptoms are you or your child having? When did the symptoms start? Does anything make the symptoms better or worse? Has anyone in your family ever had cystic fibrosis? Has growth been average and weight been stable? Cystic fibrosis. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health/cystic-fibrosis. Accessed Aug. 8, 2024. Bronchiectasis. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health/bronchiectasis. Accessed Aug. 8, 2024. FAQs: Cystic fibrosis: Prenatal screening and diagnosis. American College of Obstetricians and Gynecologists. https://www.acog.org/womens-health/faqs/cystic-fibrosis-prenatal-screening-and-diagnosis. Accessed Aug. 8, 2024. Ferri FF. Cystic fibrosis. In: Ferri's Clinical Advisor 2025. Elsevier; 2025. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Kliegman RM, et al., eds. Cystic fibrosis. In: Nelson Textbook of Pediatrics. 22nd ed. Elsevier; 2025. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Kellerman RD, et al. Cystic fibrosis. In: Conn's Current Therapy 2024. Elsevier; 2024. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Lockwood CJ, et al., eds. Respiratory diseases in pregnancy. In: Creasy and Resnik's Maternal-Fetal Medicine: Principles and Practice. 9th ed. Elsevier; 2023. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Ong T, et al. Cystic fibrosis: A review. JAMA. 2023; doi:10.1001/jama.2023.8120. Rubin R. Tackling the misconception that cystic fibrosis is a "white people's disease." JAMA. 2021; doi:10.1001/jama.2021.5086. Care centers. Cystic Fibrosis Foundation. https://www.cff.org/managing-cf/care-centers. Accessed Aug. 8, 2024. Trikafta (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.trikafta.com/. Accessed Aug. 8, 2024. Symdeko (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.symdeko.com/. Accessed Aug. 8, 2024. Orkambi (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.orkambi.com/. Accessed Aug. 8, 2024. Kalydeco (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.kalydeco.com/. Accessed Aug. 8, 2024. Pilewski JM. Update on lung transplantation for cystic fibrosis. Clinics in Chest Medicine. 2022; doi:10.1016/j.ccm.2022.07.002. Fridell JA, et al. Pancreas transplantation for cystic fibrosis: A frequently missed opportunity. Clinical Transplantation. 2021; doi:10.1111/ctr.14371. Wadsworth LE, et al. Non-invasive ventilation is associated with long-term improvements in lung function and gas exchange in cystic fibrosis adults with hypercapnic respiratory failure. Journal of Cystic Fibrosis. 2021; doi:10.1016/j.jcf.2021.05.011. Allscripts EPSi. Mayo Clinic. Medical review (expert opinion). Mayo Clinic. Oct. 18, 2024.

Source: www.mayoclinic.org ↗
02What is cystic fibrosis? A Mayo Clinic expert explains

Learn more from pulmonologist Sarah Chalmers, M.D. Cystic fibrosis (CF) is a condition passed down in families that causes damage to the lungs, digestive system and other organs in the body. CF affects the cells that make mucus, sweat and digestive juices. These fluids, also called secretions, are usually thin and slippery to protect the body's internal tubes and ducts and make them smooth pathways. But in people with CF, a changed gene causes the secretions to become sticky and thick. The secretions plug up pathways, especially in the lungs and pancreas. CF gets worse over time and needs daily care, but people with CF usually can attend school and work. They often have a better quality of life than people with CF had in past decades. Better screening and treatments mean that people with CF now may live into their mid- to late 50s or longer, and some are being diagnosed later in life.

Source: www.mayoclinic.org ↗
03What Is Cystic Fibrosis?

Cystic fibrosis (CF) is a genetic disorder, which means you get it from your parents at birth. It affects your lungs, pancreas, and other organs. CF changes the way chloride (salt) moves through the cells of your body. This causes the mucus (which should be thin and slippery) in various organs to become thick and sticky. Over time, this thick mucus builds up inside your airways, making it hard to breathe. The mucus traps germs and leads to infections and inflammation. It can also cause severe, long-term damage to the lungs and lead to respiratory failure (inability to breathe normally) and death. In the pancreas, the thick mucus caused by CF prevents the release of digestive enzymes when you eat. This leads to malnutrition and poor growth. CF can also cause liver disease, reproductive problems, and cystic fibrosis-related diabetes (CFRD). More than 40,000 people in the U.S. live with CF. Doctors diagnose about 1,000 new cases each year. Today, more than half of the CF population is aged 18 or older, and new treatments have expanded the life expectancy by decades.

Source: www.webmd.com ↗
04What Are the Symptoms of Cystic Fibrosis?

The symptoms of cystic fibrosis vary. Some children will have symptoms at birth, while others may not have symptoms for weeks, months, or even years. The severity of symptoms also varies, with some children showing only mild digestive and lung problems and others having severe food-absorption problems and life-threatening breathing complications. The most common symptoms of cystic fibrosis are: Salty-tasting skin , which parents notice when they kiss their child Frequent coughing , wheezing , or bouts of pneumonia or sinusitis Difficulty breathing that keeps getting worse Big appetite but poor weight gain Bulky, smelly, greasy bowel movements Over time, the symptoms of cystic fibrosis can worsen and may include: Chronic productive cough, recurrent lung infections Obstructive lung disease ( emphysema ) Chronic nasal congestion and sinus infections Pancreatitis , a painful inflammation of the pancreas Liver disease Diabetes Gallstones

Source: www.webmd.com ↗
05What is a sweat test?

A sweat test measures the amount of chloride in your sweat . Chloride is a type of electrolyte . Electrolytes are electrically charged minerals  that help control the amount of fluids and the balance of acids and bases (pH balance) in your body. Chloride and sodium form the salt found in your sweat.

Source: medlineplus.gov ↗
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Research and Statistics: Who Has Cystic Fibrosis?

About 40,000 people are living with cystic fibrosis in the United States, and there are approximately 105,000 people with CF worldwide. (3) More than 75 percent of people with the disease are diagnosed by age 2, and more than half of all people living with cystic fibrosis are 18 or older. CF occurs predominantly in white populations, at a rate of 1 in 2,500 births. Between 2 and 5 percent of white people are carriers of the CFTR gene variant but have no overt clinical signs of disease. The disease is less common among African Americans, occurring at the much lower frequency of approximately 1 out of 17,000 births. (15) CF gene variants are most prevalent in persons of northern and central European ancestries or of Ashkenazi Jewish descent. They are rarely found in Native Americans, Asians, or native Africans. (16) CF is equally common among men and women, but women patients fare significantly worse than male patients with the disease. The median survival age for female CF patients is about three years younger than it is for men, but the reasons for the poorer survival rates among women are not completely understood. (17)

Source: everydayhealth.com ↗
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