US group Savara Pharmaceuticals has secured $10 million in financial backing to develop AeroVanc, the trade name of the first inhaled antibiotic designed to address the growing number of methicillin-resistant staphylococcus aureus (MRSA) lung infections in people with cystic fibrosis.
In the same announcement, Savara stated that it has completed enrollment of 80 patients for a randomised, double-blind, placebo-controlled Phase 2 trial of the drug. This study is being carried out at 40 cystic fibrosis centers in the US and is evaluating the safety and efficacy of either 32 mg or 64 mg doses of AeroVanc inhaled twice daily. The company says it expects top line results to be available in the first quarter of 2015.
The AeroVanc Inhaler is a plastic device used for inhaling the AeroVanc and placebo powders. For the study, AeroVanc and placebo capsules are supplied in aluminum foil laminated blisters, and the blister strips are packaged into a wallet that contains one week’s supply of study drug. To use the delivery system, an AeroVanc or placebo capsule is placed in the well of the AeroVanc Inhaler, and the capsule is pierced by pressing and releasing the buttons on the sides of the device. The AeroVanc or placebo powder is dispersed into the air stream when the patient inhales rapidly and deeply through the mouthpiece.
“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.