Vancomycin inhalation powder (trade name, AeroVanc) is the first dry-powder inhaled version of the antibiotic vancomycin being developed for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in people with cystic fibrosis (CF).
AeroVanc is still investigational, meaning that it is not yet approved by the United States Food and Drug Administration (FDA) for use. The FDA has given the therapy Fast Track and Orphan Drug designations, as well as Qualified Infectious Disease Product (QIPD) status, potentially providing Savara Pharmaceuticals, the developer of AeroVanc, with 12 years of market exclusivity should it be approved.
How AeroVanc works
Vancomycin inhalation powder is a dry-powder form of vancomycin, self-administered using a capsule-based device. Vancomycin is the treatment of choice for MRSA-related bronchopneumonia. However, this antibiotic has systemic side effects and requires intravenous (IV) administration, a less-than-convenient form of treatment that can also prevent the drug from reaching its target (the lungs) at necessary levels.
Because AeroVanc delivers vancomycin directly to a lung infection, it is expected to improve the drug’s clinical efficacy and lessen the adverse effects caused by broad-spectrum antibiotics.
AreoVanc clinical testing
A Phase 2 (NCT01746095) randomized, double-blind study of AeroVanc’s efficacy and safety in treating MRSA lung infection in people with CF, versus placebo, found that treated patients had a significant reduction in MRSA density in their sputum compared to the placebo group. It also improved pulmonary function and respiratory symptoms, lowered the time to exacerbation, and reduced the need for other antibiotics.
The study evaluated the effectiveness, safety, and pharmacokinetics of AeroVanc compared to placebo in about 80 CF patients with chronic MRSA lung infection. Effectiveness was measured by determining how much MRSA grows in the sputum of the participants over time, as well as through changes in lung function (FEV1), symptoms, and the need for other treatments.
A Phase 3 clinical trial is now being planned for the U.S and Canada, supported by $20 million raised in a Series C financing round that concluded in 2016.
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