Savara has announced the initiation of a Phase 3 study of its AeroVanc vancomycin DPI for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients.
The AVAIL study is expected to enroll about 200 patients who will receive either twice daily AeroVanc or an inhaled placebo in the first portion of the study over 24 weeks or 3 dosing cycles of 28 treatment days followed by 28 observation days. In the subsequent long-term safety study portion of the trial, patients will get open-label AeroVanc for 24 weeks or 3 dosing cycles.
Savara CEO Rob Neville said, “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. 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.”
In 2015, Savara announced positive results from a Phase 2 study of AeroVanc in CF patients. In March 2016, the company said that it had raised $20 million to fund a Phase 3 trial.
AeroVanc has Orphan Drug, Fast Track and QIDP designations from the FDA for the treatment of MRSA lung infection in CF patients.
Read the Savara press release.
