- Savara Inc. (SVRA, Financial) presented Phase 3 IMPALA-2 trial data on molgramostim for aPAP at ATS 2025, showing reduced surfactant burden and improved quality of life.
- The trial demonstrated significant reductions in ground-glass opacification scores and the need for whole lung lavages for patients using molgramostim.
- Molgramostim improved respiratory health-related quality of life, with favorable outcomes in physical activity levels and symptom severity.
Savara Inc. (SVRA), a company specializing in treatments for rare respiratory diseases, unveiled pivotal data from its Phase 3 IMPALA-2 clinical trial at the American Thoracic Society Conference 2025. This trial focuses on the efficacy of molgramostim inhalation solution in patients with autoimmune pulmonary alveolar proteinosis (aPAP).
The IMPALA-2 trial results highlighted that molgramostim significantly reduces surfactant burden. This is evidenced by a marked decrease in ground-glass opacification (GGO) scores, with a mean reduction from baseline to Week 24 of -2.1 in the molgramostim group versus -1.1 in the placebo group (P=0.0004). Furthermore, fewer patients required rescue whole lung lavages, with only 6 out of 78 in the molgramostim group needing the procedure compared to 11 out of 79 in the placebo group.
Additionally, molgramostim showed benefits in respiratory health-related quality of life (HRQoL) and patient-reported outcomes. Notable improvements were recorded in the St. George’s Respiratory Questionnaire (SGRQ) Impact and Symptom scores and the EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) assessments. Significant enhancements were observed regarding mobility, self-care, and usual activities at both Weeks 24 and 48.
This trial, conducted across 16 countries, supports molgramostim's potential as an effective therapeutic option for aPAP, with further analyses showing improved patient quality of life and reduced severity of breathing problems.
