Savara Pharmaceuticals’ lead product candidate, AeroVanc™ (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is being developed for the treatment of MRSA lung infection in cystic fibrosis patients and other high-risk patient populations in the critical care setting. Vancomycin administered by IV is the antibiotic of choice for MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. By delivering vancomycin directly to the site of infection in the lungs, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure. AeroVanc was recently granted orphan drug status by the U.S. Food and Drug Administration.
Savara recently completed enrollment on a Phase IIa clinical study of AeroVanc’s safety and efficacy, which was carried out at 40 cystic fibrosis centers throughout the U.S. Results are expected in Q1-2015. Click here if you are interested in learning more about this study. In Phase I studies of AeroVanc in healthy volunteers and cystic fibrosis patients, AeroVanc was well tolerated and demonstrated an excellent pharmacokinetic profile.