Savara Pharmaceuticals has announced the commencement of a Phase 2 clinical trial of its AeroVanc inhaled dry powder vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will involve 80 CF patients across the US. Results should be available in the first quarter of 2014, the company said.
The FDA granted AeroVanc orphan drug designation in November 2012, and Savara recently announced a $4 million grant from the National Heart, Lung and Blood Institute and additional investments to fund the Phase 2 studies.
Savara CEO Rob Neville commented, “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. 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.”
Read the Savara press release.
