The purpose of this research study is to evaluate the effectiveness, safety, and pharmacokinetics of AeroVanc compared to placebo in subjects with CF and a chronic MRSA lung infection.
ENROLLMENT IS NOW COMPLETE.
THE MAP BELOW SHOWS THE PARTICIPATING STUDY CENTERS:
(click the markers on map for details)
Inhaled antibiotics are becoming the cornerstone of treatment in patients with cystic fibrosis and other chronic care patients who experience frequent lung infections, specifically Pseudomonas aeruginosa infections. Despite these advancements, there are currently no approved inhaled drugs or cures to treat methicillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis―a life-threatening infection known to shorten the lives of affected patients including children. Vancomycin administered intravenously is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia in cystic fibrosis patients, however, this method does not achieve optimal penetration into the lungs and systemic toxicities limit its use in a chronic setting.
Savara Pharmaceuticals’ lead product candidate is AeroVanc™ (vancomycin hydrochloride inhalation powder), the first inhaled antibiotic being developed to address the growing population of MRSA-infected cystic fibrosis patients. By delivering vancomycin directly to the site of infection, AeroVanc has the ability to improve clinical efficacy and reduce adverse effects caused by broad-spectrum antibiotics.
Enrollment is now complete on the AeroVanc phase II trial that recruited cystic fibrosis (CF) patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection to determine the effectiveness, safety, and pharmacokinetics of a new investigational inhalable powder formulation of vancomycin (NCT01746095; http://clinicaltrials.gov). Results are expected in Q1-2015. A total of 40 study centers are involved across the U.S. The study sponsor is Savara Pharmaceuticals. Funding has been provided through private investors, as well as an award from CF Foundation Therapeutics, the research and development arm of the U.S. CF Foundation.