Savara (NASDAQ:SVRA) reported that its Phase 3 AVAIL trial evaluating AeroVanc for the treatment of cystic fibrosis failed to meet its primary endpoint.
The trial enrolled 55 cystic fibrosis patients with methicillin-resistant staphylococcus aureus lung infection who received either AeroVanc, a vancomycin hydrochloride inhalation powder, or placebo.
The study failed to meet the primary endpoint of the mean absolute change in forced exhalation volume in one second percent predicted from baseline at week 4, week 12, and week 20.
“Unfortunately, based on the AVAIL results, we are discontinuing further development of AeroVanc,” Badrul Chowdry, M.D., Ph.D., Savara’s CMO, said in a statement.
Savara noted that it also will be discontinuing development of Apulmiq, a ciprofloxacin inhalation powder, for the treatment of non-cystic fibrosis bronchiectasis.
The company will focus its resources on the development of Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis, which is slated to enter a Phase 3 trial in the second quarter of 2021.
