Savara Pharmaceuticals has announced the completion of enrollment in a Phase 2 trial of its AeroVanc vancomycin DPI for the treatment of for the treatment of methicillin-resistant S. aureus (MRSA) lung infections in cystic fibrosis patients, as well as the closing of a $10 million bridge financing round for further development.
In December 2013, AeroVanc received Fast Track designation from the FDA and was designated as a Qualified Infectious Disease Product (QIDP) for that indication. The product received orphan drug designation in the US in November 2012.
The 80-patient double-blind, placebo-controlled trial will test two twice-daily doses of AeroVanc, 32 mg and 64 mg. Top line results should be available early in 2015, the company said.
Savara CEO Rob Neville commented, “First and foremost, Savara will use the additional financing to support the continued development of AeroVanc for people with CF who often struggle with persistent MRSA infection. In addition, the financing adds to our resources for corporate development as we look to expand our pipeline to prepare for Savara’s next stage of growth.”
Read the Savara press release.