Press release
New England Journal of Medicine (NEJM) to Publish Results From Savara’s Pivotal Phase 3 IMPALA-2 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
-- In the Largest Clinical Trial Conducted in Autoimmune PAP, Molgramostim Inhalation Solution (Molgramostim) Reduced Surfactant Burden and Improved
About this update from Savara, Inc.
[{"type":"text","content":"\n-- In the Largest Clinical Trial Conducted in Autoimmune PAP, Molgramostim Inhalation Solution (Molgramostim) Reduced Surfactant Burden and Improved Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life, and Patient Functionality --\n\n\n LANGHORNE, Pa.--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM. The manuscript, titled “A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis” will appear in the August 21, 2025, online version of the publication and can be found at www.nejm.org. Following the online publication in NEJM, the manuscript will be available on the Congresses & Publications page of the Company’s corporate website.\n\n\n“IMPALA-2, the largest and longest Phase 3 clinical trial conducted in patients with autoimmune PAP, demonstrated that 48 weeks of once daily administration of inhaled molgramostim addresses the underlying pathophysiology of this chronic rare lung disease,” said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and Lead Clinical Investigator of the IMPALA-2 trial. “Treatment with molgramostim improved the cardinal manifestations of autoimmune PAP, namely it reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. Additionally, molgramostim was well tolerated with no notable safety concerns.”\n\n\nIMPALA-2 achieved statistical significance on its primary endpoint, change from baseline in the hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24. Molgramostim significantly improved pulmonary gas transfer as measured by DLco% at Week 24 compared with placebo (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P","length":3089,"tagName":"div"}]