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Savara Announces Presentation of Phase 3 IMPALA-2 Trial Results for Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

9 months ago2 min read

Key Insights

  • Savara Inc. will present results from the Phase 3 IMPALA-2 trial of inhaled molgramostim at the British Thoracic Society Winter Meeting.

  • The presentation will highlight molgramostim's impact on improving pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.

  • The IMPALA-2 trial evaluated molgramostim, a recombinant human GM-CSF, delivered via eFlow Nebulizer, for treating autoimmune pulmonary alveolar proteinosis.

Savara Inc. (Nasdaq: SVRA) announced that results from the pivotal Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP) will be presented at the British Thoracic Society (BTS) Winter Meeting in London, England, November 27-29, 2024.
The platform presentation, titled "Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2," will be delivered by Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at University College Dublin and Consultant Respiratory Physician at St. Vincent’s University Hospital in Dublin, Ireland, on November 29, 2024.

IMPALA-2 Trial Details

The IMPALA-2 trial evaluated the efficacy and safety of molgramostim, a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), in patients with aPAP. Molgramostim is administered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically designed for inhalation of large molecules. The study focused on improvements in pulmonary gas exchange and respiratory health-related quality of life.

Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

aPAP is a rare lung disease characterized by the accumulation of surfactant in the alveoli, impairing gas exchange. This build-up occurs because antibodies neutralize GM-CSF, hindering alveolar macrophages from clearing surfactant effectively. Symptoms include shortness of breath, cough, and fatigue, potentially leading to lung fibrosis or the need for a lung transplant.
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