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Savara Pharmaceuticals Initiates Phase 2 Clinical Trial of AeroVanc for MRSA Lung Infection in Cystic Fibrosis Patients
Date:4/18/2013

ngs and systemic toxicities, limit its use in a chronic setting. In contrast to the established treatment of Pseudomonas aeruginosa lung infection with inhaled antibiotics, there is no FDA-approved inhaled antibiotic treatment available for MRSA lung infection.

Savara's Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study in 80 CF patients at 22 CF centers nationwide. Patients will receive either 32 mg or 64 mg doses of AeroVanc or a corresponding placebo twice daily for 28 days. The primary objective of the study is to evaluate the efficacy of AeroVanc in reducing the quantity of MRSA colony forming units in the sputum cultures. The secondary objectives include evaluation of the efficacy of AeroVanc in improving lung function, reducing respiratory symptoms reported by the patients, and reducing the use of other antibiotics. Study results are expected in the first quarter of 2014.

"We are encouraged by the recent FDA approval of Novartis' dry-powder TOBI Podhaler for Pseudomonas aeruginosa infections in CF patients. An inhaled dry powder form of vancomycin for MRSA infection will be a logical addition to this and other treatment options available for CF patients," said Rob Neville , CEO of Savara Pharmaceuticals. "We are further encouraged by the strong interest and support of key opinion leaders, and the feedback that AeroVanc is exactly what the CF care community has been waiting for."  

Details of the AeroVanc Phase 2 study can be found at www.clinicaltrials.gov (study identifier NCT01746095).

About AeroVanc

Intravenous vancomycin is the antibiotic of choice for MRSA-related bronchopneumonia, however, the burden of IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry
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