Molgradex · Autoimmune (acquired) pulmonary alveolar proteinosis
Development and Regulatory status
Trial or other data
Jun 19: results of PIII IMPALA trial announced, the study did not meet its primary endpoint of alveolar-arterial oxygen gradient (A-aDO2), with an estimated 4.6 mmHg treatment difference (p=0.17) 
Feb 16: PIII IMPALA (NCT02702180) study starts. This study evaluates inhaled molgramostim in the treatment of 51 autoimmune PAP adult patients. A third of the patients will receive inhaled molgramostim daily for 24 weeks, a third will receive inhaled molgramostim every other day for 24 weeks and a third will receive inhaled matching placebo for 24 weeks. Study sites include Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Russia, Switzerland & United Kingdom. Primary outcome is absolute change from baseline to 24 weeks of Alveolar - arterial oxygen concentration; collection of these data is expected to complete Aug 17 .