Clinical-stage specialty pharmaceutical company, Savara, Inc. today announced the initiation of the AVAIL study, a Phase III, randomized, double-blind, placebo-controlled study of AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals living with cystic fibrosis (CF).
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Inhaled antibiotics are standard of care for gram negative Pseudomonas aeruginosa lung infection in individuals living with CF. However, there are no approved inhaled treatment options for gram positive MRSA lung infection despite the increase in MRSA prevalence, now affecting approximately 26% of people with CF in the United States.
Related: Savara completes enrollment for AeroVanc, inhaled MRSA drug for cystic fibrosis, phase 2 trials
“Persistent MRSA infection is associated with increased use of intravenous antibiotics, increased hospitalizations, a faster decline of lung function, as well as shortened life expectancy. Based on the completed Phase II study, AeroVanc represents a promising opportunity to make significant advancement in the treatment of this debilitating infection,” said Elliott Dasenbrook, MD, MHS, Assistant Professor of Medicine and Director of the Adult Cystic Fibrosis Program at Cleveland Clinic, Cleveland, OH.
Dr. Dasenbrook served as the Coordinating Investigator in the AeroVanc Phase II study, conducted in the United States in 87 subjects with CF.
“Consistent with our prior milestone timing guidance, we are very pleased to announce that patient enrollment is underway in our pivotal AVAIL study of AeroVanc,” stated Rob Neville, CEO of Savara. “The initiation of the AVAIL study represents a substantial milestone for Savara and serves to underscore our team’s commitment to deliver on time. We believe positive results from the AVAIL study would set us up for submission of an NDA, and we are excited to begin turning our attention towards commercialization.”
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