Savara Pharmaceuticals announced today that it closed a $10 million bridge financing round to support the development of AeroVanc, the first inhaled antibiotic being developed to address the growing number of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in people with cystic fibrosis (CF). Previous investors participated in the financing, and new investors include boutique investment funds and family offices.
Concurrent with the financing, Savara announced it has completed enrollment in its 80-patient randomized, double-blind, placebo-controlled Phase 2 trial of AeroVanc. This study is being carried out at 40 CF centers nationwide and is evaluating the safety and efficacy of either 32 mg or 64 mg doses of AeroVanc inhaled twice daily. The company expects top line results to be available in the first quarter of 2015.
“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,” said Rob Neville, Chief Executive Officer of Savara Pharmaceuticals. “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.”
Last December the U.S. Food and Drug Administration designated AeroVanc as a Qualified Infectious Disease Product (QIDP) and granted it Fast Track status in this lead indication, providing access to incentives including priority review and an additional five years of market exclusivity. The product also has an orphan designation, providing a total of 12 years of market exclusivity.
Vancomycin is an FDA-approved intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. AeroVanc is an investigational, proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is currently being developed as a treatment for persistent MRSA lung infection in people with CF. By delivering vancomycin directly to the lungs, higher vancomycin concentrations are achieved at the site of infection, which is expected to lead to improved clinical efficacy. In addition, direct delivery of the drug into the lungs reduces exposure to the drug elsewhere in the body, and is thereby expected to reduce the risk of systemic drug-related side effects.