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Savara launches late-stage study of AeroVanc in CF patients with MRSA lung infections

Sep. 26, 2017 12:17 PM ETSavara Inc. (SVRA) StockBy: Douglas W. House, SA News Editor
  • Savara (NASDAQ:SVRA -0.6%) initiates a Phase 3 clinical trial, AVAIL, assessing AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of cystic fibrosis (CF) patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infections, a population with no approved inhaled therapeutic options.
  • AVAIL will enroll ~200 subjects who will be randomized to receive either AeroVanc (30 mg) twice daily or placebo via inhalation for 24 weeks in the first period of the trial. In the second period, which will be open-label, participants will receive the same dosing regimen for an additional 24 weeks aimed at evaluating long-term safety.
  • The primary endpoint is the mean absolute change in lung function from baseline measured by FEV1 (the maximum amount of air that can be forcefully blown out of the lungs in one second). According to ClinicalTrials.gov, the estimated completion date is December 2019.
  • AeroVanc has Orphan Drug and QIDP status in the U.S. for the indication.

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