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Inhaled Dry-Powder Vancocymcin (AeroVanc) Reduces MRSA in Cystic Fibrosis Patients
Positive results have been reported from a phase II clinical trial of AeroVanc (Savara Pharmaceuticals), the first inhaled antibiotic being developed to address the problem of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in patients with cystic fibrosis (CF).
AeroVanc is an investigational, inhaled dry-powder form of vancomycin in a capsule-based device designed for self-administration.
In the new study, AeroVanc significantly reduced MRSA density in sputum (the trial’s primary endpoint) compared with placebo. The treatment also showed encouraging trends in the trial’s secondary endpoints, including clinically meaningful improvements in pulmonary function, in respiratory symptoms, in the time to exacerbation, and in the need for other antibiotics, compared with placebo.
Vancomycin is an FDA-approved, intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. However, poor penetration into the lungs and systemic toxicities limit its use as a chronic treatment.
The AeroVanc phase II trial was a randomized, double-blind, placebo-controlled study involving 87 people with CF and persistent MRSA lung infection. The study’s objective was to evaluate the safety and efficacy of either 32-mg or 64-mg doses of the dry powder form of vancomycin inhaled twice daily for 28 days.
The most common adverse event was cough, with no difference between the two dose levels or between the active and placebo groups. Symptoms consistent with bronchoconstriction were observed more often in subjects treated with AeroVanc at the 64-mg dose. All strains of MRSA were susceptible to vancomycin, and no change in the minimum inhibitory concentration distribution was observed during or after the AeroVanc treatment.
AeroVanc is currently being developed as a treatment for persistent MRSA lung infection in patients with CF. By delivering vancomycin directly to the lungs, higher vancomycin concentrations are achieved at the site of infection, which is expected to lead to improved clinical efficacy. In addition, direct delivery of the drug into the lungs reduces exposure to the drug elsewhere in the body, and is therefore expected to reduce the risk of systemic drug-related adverse effects. AeroVanc has received the FDA’s “fast track” and “orphan drug” designations as well as “qualified infectious disease product” status, which provides 12 years of market exclusivity.
CF is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in the loss of lung function. As the disease progresses, the lungs of people with CF are typically infected with bacteria that are difficult to eradicate. Physicians have been using nebulized antibiotics to treat these infections and have sought new options for treatment in the chronic-care setting.
MRSA infections have become increasingly common, affecting almost 30% of the estimated 32,000 people with CF in the U.S. Persistent MRSA infections are associated with a more rapid decline in lung function and reduced survival. Currently, no approved inhaled therapy is available for MRSA infection in patients with CF.
Source: Savara Pharmaceuticals; February 23, 2015.