AeroVanc is a novel inhalable dry-powder form of vancomycin being developed by Savara Pharmaceuticals for the treatment of respiratory methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis (CF) patients.
Vancomycin is the most effective antibiotic to treat chronic MRSA infections, which are associated with a faster decline in lung function in CF patients. However, vancomycin as an oral treatment, inhaled aerosol, or intravenous injection yields poor results because of poor absorption in the gastrointestinal tract, rapid clearance by kidneys, poor lung penetration, and systemic toxicity.
AeroVanc is an investigational drug that has been given fast track and orphan drug designations, as well as qualified infectious disease product status by the U.S. Food and Drug Administration.
How AeroVanc works
Vancomycin is a glycopeptide antibiotic that kills gram-positive bacteria such as S.aureus by inhibiting bacterial cell wall formation and RNA synthesis, and altering the permeability of these cell membranes, all of which are necessary for their survival.
AeroVanc is delivered directly to the lungs of CF patients using an off-the-shelf inhaler device.
AeroVanc in clinical trials
Phase 1 clinical trials conducted in healthy volunteers and CF patients testing AeroVanc showed positive safety and tolerability results.
A Phase 2, randomized, double-blind, placebo-controlled study (NCT01746095) — conducted by Savara in collaboration with Synteract and the Cystic Fibrosis Foundation — found a significant reduction in MRSA density in the sputum of AeroVanc-treated CF patients compared with a placebo group. The treatment also improved lung function, reduced respiratory symptoms, lowered the time to exacerbation of symptoms, and reduced the need for other antibiotics.
Savara is currently conducting a Phase 3, randomized, double-blind, placebo-controlled study (NCT03181932) called AVAIL in multiple centers in the U.S. and Canada to evaluate whether CF patients treated with AeroVanc will show significant improvement in lung function.
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