Press release
Savara Presents New Data From the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the European Respiratory Society (ERS) Congress 2025
– The Beneficial Clinical Effects of Molgramostim Were Similar in Patients with aPAP Regardless of Disease Severity Defined by DLco% – – Changes in DLco%,
About this update from Savara, Inc.
[{"type":"text","content":"\n– The Beneficial Clinical Effects of Molgramostim Were Similar in Patients with aPAP Regardless of Disease Severity Defined by DLco% –\n\n\n– Changes in DLco%, the Primary Endpoint in IMPALA-2, Were Significantly Correlated with Changes in Measures of Quality of Life, Patient Functionality, and Surfactant Burden in Patients with aPAP –\n\n\n– Savara’s Partner, TrilliumBiO, Presented Data on the Development of a Dried Blood Spot Test to Aid in the Diagnosis of aPAP –\n\n\n LANGHORNE, Pa.--(BUSINESS WIRE)--\nSavara Inc. (the “Company”) (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced additional analyses from its pivotal Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP were presented as poster presentations at the ERS Congress 2025 in Amsterdam, The Netherlands.\n\n\nERS 2025 Posters\n\n\nSavara\n\n\nTitle: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)\nPresenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at the University College Dublin (UCD) and Consultant Respiratory Physician, St. Vincent’s University Hospital, Dublin, Ireland\nPoster Number: PA3026\n\n\nPoster Summary:\n\n\n\nPrespecified analyses were conducted to determine if the beneficial clinical effects of molgramostim in IMPALA-2, a Phase 3 clinical trial, were similar in patients with aPAP based on their disease severity as measured by hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide, or DLco% (≤50% or >50%) at randomization\n\n\n\nMolgramostim demonstrated improvement compared with placebo on the primary endpoint, change in DLco% from baseline to Week 24, in patients with aPAP regardless of disease severity\n\n\n\nMolgramostim significantly improved measures of pulmonary gas transfer (DLco%), respiratory health-related quality of life (St. George’s Respiratory Questionnaire [SGRQ] Total and Activity scores), and patient functionality (exercise capacity expressed as peak metabolic equivalents [METs]) compared with placebo in both subgroups of patients with DLco% values of ≤50% or >50% at randomization\n\n\n\nTitle: Relationship Between Pulmonary Gas Transfer, Respiratory Health-related Quality of Life (HRQoL), Exercise Capacity, and Surfactant Burden in Autoimmune Pulmon...