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Positive Phase 2 results for Savara’s AeroVanc

Savara Pharmaceuticals has announced positive results from a Phase 2 trial of its AeroVanc vancomycin DPI for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. In the 28-day trial, patients treated with AeroVanc had a statistically significant reduction in MRSA density in sputum compared to patients treated with placebo. According to the company, secondary endpoints including improvement in pulmonary function, time to exacerbation, and reduction of respiratory symptoms all “showed encouraging trends.”

The trial involved 87 CF patients with persistent MRSA infections who took either a 32 mg dose of AeroVanc, a 64 mg dose of AeroVanc, or placebo twice daily for the 28-day period. No difference in the frequency of adverse reactions was observed between the two dose levels or between AeroVanc and placebo, with cough being the most frequently reported adverse event.

Savara CEO Rob Neville commented, “It is well known that people with CF who suffer from chronic Pseudomonas lung infection greatly benefit from inhaled antibiotics, such as TOBI. MRSA prevalence has increased dramatically over the past decade, but there is no inhaled antibiotic available for chronic treatment. Based on the observed clinical benefits in our study, we believe that AeroVanc can be equally successful for treatment of MRSA as the current inhaled antibiotics have been for Pseudomonas.”

In October 2014, Savara announced that the company had raised $10 million for development of AeroVanc for this indication.

Read the Savara press release.

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published on February 23, 2015

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