There are approximately 30,000 people living with cystic fibrosis in the U.S. Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and chronic lung infections resulting in gradual loss of lung function. The most prevalent lung pathogen in cystic fibrosis patients is Pseudomonas aeruginosa, which is commonly treated using inhaled antibiotics. In recent years, methicillin-resistant Staphylococcus aureus (MRSA), a bacterium that is resistant to conventional antibiotics (1),  has become increasingly common, with a prevalence of almost 30% of the U.S. cystic fibrosis patient population. Recent publications indicate that cystic fibrosis patients with chronic MRSA infection have more hospitalizations, faster decline in lung function, and reduced life expectancy. (2, 3)

1 Gorwitz RJ et al. Journal of Infectious Diseases. 2008:197:1226-34.
2  Elliott C. Dasenbrook; William Checkley; Christian A. Merlo; Michael W. Konstan; Noah Lechtzin; Michael P. Boyle. Association Between Respiratory Tract Methicillin-Resistant Staphylococcus aureus and Survival in Cystic Fibrosis. JAMA, 2010; 303 (23): 2386-2392

(Dasenbrook et al, reprinted with permission, Copyright © (2010) AMA. All rights reserved.)

Vacomycin is one of most commonly used drugs for the treatment of MRSA infection, but it is available only as an intravenous formulation. Currently there is no approved inhaled therapy for MRSA infection, despite the established practice of treating infections of cystic fibrosis patients directly at the site of infection—the lungs. Developing the first inhaled MRSA-antibiotic, AeroVanc, is Savara’s primary focus.

Need to Treat Persistent MRSA Infection

§ Dasenbrook et al. 2010 – Reduced survival associated with a persistent MRSA lung infection in CF patients.
§ Dasenbrook et al. 2008 – Increased rate of decline of pulmonary function (FEV1) in young (8-21 years) CF patients with persistent MRSA lung infection.
§ Sanders et al. 2010 – This paper suggests that 25% of patient do not recover back to their baseline FEV1 after an exacerbation. Risk factors for poor recovery included pulmonary MRSA and Pseudomonas infection.
§ Vanderhelst et al. 2011 – MRSA colonization was associated with an increased rate of FEV1 decline.