Savara completes enrollment of IMPALA Phase 3 study
Savara announced completion of the target enrollment of 135 patients in IMPALA, its global pivotal Phase 3 clinical study evaluating its lead product candidate Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor, for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP. Savara remains on track to report top line results from the study in Q2 2019. Molgradex is also being investigated in an open-label, multicenter, safety extension study, called IMPALA-X, to determine the long-term safety and utilization of Molgradex in patients with aPAP. IMPALA-X offers patients the opportunity to continue treatment with Molgradex for up to three years after completion of the pivotal Phase 3 IMPALA study.