Rare Daily Staff

Savara, a biopharmaceutical company focused on rare lung disease, said it received a development award of up to $5 million from the nonprofit drug discovery and development affiliate of the CF Foundation to support the continued development of AeroVanc, the first inhaled antibiotic being developed for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in individuals living with cystic fibrosis.

“We believe this award serves as strong validation of our AeroVanc program,” stated Rob Neville, CEO of Savara.

The funding can be used to support the company’s ongoing late-stage pivotal AVAIL study of AeroVanc. It can be drawn down by Savara as needed upon the achievement of continued progress and certain milestones of the AeroVanc program and the study.

In September 2017, Savara announced that its pivotal study AVAIL was open for enrollment. The study is a late-stage, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of MRSA lung infection in individuals living with cystic fibrosis. The study will enroll approximately 200 subjects at more than 80 clinical study sites across the United States and Canada.

“Cystic fibrosis has been a primary focus of my research interests for many years. Inhaled antibiotics have become the standard of care to treat Pseudomonas aeruginosa lung infection and we are now on the verge of demonstrating that a similar approach should be used for MRSA,” said Patrick Flume, director of Adult Cystic Fibrosis Center and professor of medicine and pediatrics at the Medical University of South Carolina and coordinating principal investigator of the AVAIL study. “AeroVanc has shown potential as a novel treatment for MRSA lung infection, a growing problem not currently addressed by any other available inhaled antibiotics,”

AeroVanc has been granted Orphan Drug Designation and Qualified Infectious Disease Product designation.

November 29, 2017

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