Savara Presents New Biomarker Data From Double-Blind Period Of IMPALA-2 Phase 3 Clinical Trial Evaluating Molgramostim For Treatment Of aPAP, At ATS 2026 International Conference
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Savara 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.
Below is a summary of the poster presented.
Poster 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.
- Presented 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.
- Molgramostim 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.
- Strong 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.
- Conclusions: Biomarker levels associated with aPAP disease severity decreased in patients treated with molgramostim. Additionally, decreased levels of biomarkers were associated with improvements in pulmonary gas transfer.
