for Autoimmune pulmonary alveolar proteinosis (aPAP)
Originally AUG 22 2026; extended to NOV 22 2026 (Major amendment — Savara's responses to FDA information requests; FDA cited no safety, efficacy, or manufacturing concerns, announced APR 15 2026).
Autoimmune pulmonary alveolar proteinosis is a rare lung condition in which fatty proteins from surfactant build up inside the air sacs, blocking normal gas exchange and making breathing difficult while raising the risk of lung infections. Molbreevi (molgramostim) is an inhaled form of a natural growth factor that helps immune cells in the lungs called macrophages mature and do their cleanup work. Because those cells are the ones that normally clear out excess surfactant, delivering this signal directly to the lungs may help them break down the buildup and potentially ease breathing.
The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP.
Source: ClinicalTrials.gov