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Savara Presented New Biomarker Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2026
Savara Presented New Biomarker Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary
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[{"type":"text","content":"\nSavara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reported new biomarker data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP.\n\n\nBelow is a summary of the poster presented.\n\n\nPoster Board 401: “Relationship Between Pulmonary Gas Transfer and Biomarker Levels in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP),” presented by Y. Inoue, M.D.; sponsored by Savara Inc.\n\nPresented serum biomarker data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which aPAP patients received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. Blood samples were collected at baseline and at Weeks 4, 12, 24, and 48, measuring levels of Krebs von den Lungren protein-6 (KL-6), cytokeratin 19 fragments (CYFRA 21-1), carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), hemoglobin, and hematocrit. At baseline, all biomarker levels were similar between the molgramostim and placebo groups.\n\n\n\nMolgramostim significantly improved pulmonary gas transfer, as measured by change from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide adjusted for hemoglobin (DLco%) at Week 24 (P=0.0007) and Week 48 (P=0.0008) versus placebo. Post-hoc analyses showed that patients in the molgramostim group also demonstrated significantly greater mean decreases from baseline in LDH (Week 24, P=0.0150; Week 48, P=0.0051), CYFRA 21-1 (Week 24, P=0.0036; Week 48, P=0.0017), and KL-6 (Week 24, P=0.0016; Week 48, P=0.0022) compared with placebo. Mean changes from baseline in hemoglobin, hematocrit, and CEA at Weeks 24 and 48 were similar between the treatment groups.\n\n\n\nStrong correlations were observed in the overall study population (pooled treatment groups) between improvements in DLco% and decreases in LDH (Week 24, r=−0.5154; Week 48, r=−0.6266), CYFRA 21-1 (Week 24, r=−0.6414; Week 48, r=−0.6908), and KL-6 (Week 24, r=−0.7286; Week 48, r=−0.6864), all P<0.0001.\n\nConclusions: Biomarker levels associated with aPAP disease severity decreased in patients treated with m...