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AeroVanc reduces MRSA in patients with cystic fibrosis
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The first inhaled antibiotic in development to address the mounting issue of MRSA lung infection in patients with cystic fibrosis met the primary endpoint in a phase 2 trial, according to a news release from Savara Pharmaceuticals.
AeroVanc, the inhaled dry powder form of vancomycin already approved by the FDA to treat MRSA intravenously, reduced MRSA density in sputum and improved pulmonary function, respiratory symptoms, and the time to exacerbation and need for other antibiotics.
“The consistency of effect across all clinically relevant endpoints in the AeroVanc study was very encouraging, as was the magnitude of the treatment effect,” Michael Konstan, MD, of the department of pediatrics, Case Western Reserve University School of Medicine and Rainbow Babies and Children’s Hospital. “The unmet need in people with cystic fibrosis and persistent MRSA is substantial, and this study gives much hope for an important new therapeutic option.”
In a randomized, double blind, placebo-controlled trial involving 87 patients with cystic fibrosis and persistent MRSA lung infection, Konstan and colleagues assessed safety and efficacy of two different doses (32 mg or 64 mg) of the dry powder inhaled twice daily over 28 days.
The inhaled antibiotic, delivered in a capsule-based device designed for self-administration, removes the factors of poor lung penetration and systemic toxicities that limit the intravenous drug as a chronic treatment.
Higher vancomycin concentrations at the site of infection through direct lung delivery would be expected to improve clinical efficacy, according to the release.
Cough was the most commonly reported adverse event; no difference was seen between dose levels or between therapy and placebo groups. Symptoms consistent with bronchoconstriction were observed more frequently in patients treated with AeroVanc 64 mg.
All MRSA strains were susceptible to vancomycin. The investigators observed no change in the minimum inhibitory concentration distribution during or after the inhaled treatment.
“MRSA prevalence has increased dramatically over the past decade, but there is no inhaled antibiotic available for chronic treatment,” Rob Neville, CEO of Savara Pharmaceuticals, said in the release. “Based on the observed clinical benefits in our study, we believe that AeroVanc can be equally successful for treatment of MRSA as the current inhaled antibiotics have been for Pseudomonas.”