LANGHORNE, Pa.: Savara Inc. (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, presented encouraging new results from its Phase 3 IMPALA-2 trial at the American Thoracic Society (ATS) 2025 International Conference.
The data reinforce the clinical potential of molgramostim inhalation solution in treating autoimmune pulmonary alveolar proteinosis (aPAP).
Presented through two key scientific posters, the results showcased significant reductions in surfactant burden, fewer whole lung lavage (WLL) procedures, and notable improvements in health-related quality of life (HRQoL) metrics for patients treated with molgramostim.
Key Poster Highlights from ATS 2025:
- Reduction in Surfactant Burden and WLL Requirements
Molgramostim significantly decreased surfactant accumulation in the lungs as evidenced by a greater reduction in ground-glass opacification (GGO) scores compared to placebo (-2.1 vs. -1.1; P=0.0004).
Fewer patients required WLL in the molgramostim group (7.4%) compared to placebo (13.3%).
- Improvement in Respiratory Quality of Life
HRQoL indicators such as the St. George’s Respiratory Questionnaire (SGRQ) and EQ-5D-5L showed statistically significant improvements at both 24 and 48 weeks.
Patients treated with molgramostim reported reduced severity of breathing problems and increased daily physical activity levels versus placebo (P-values ranging from 0.0084 to 0.0193).
About the IMPALA-2 Trial
IMPALA-2 is a global, pivotal Phase 3 randomized, double-blind, placebo-controlled trial evaluating molgramostim 300 mcg inhaled daily over 48 weeks. Conducted across 43 sites in 16 countries, the trial assessed lung function, exercise capacity, HRQoL, and safety outcomes in patients with aPAP.
Patients completing the 48-week double-blind phase have transitioned into a 96-week open-label period with ongoing molgramostim treatment.
About aPAP
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung condition caused by an accumulation of surfactant in the alveoli due to GM-CSF neutralizing autoantibodies. This disrupts surfactant clearance by alveolar macrophages, leading to shortness of breath, fatigue, and potentially serious complications such as lung fibrosis or the need for a lung transplant.
About Savara
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Savara’s lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule.
