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 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.
The full content of this poster will be available on the Congresses and Publications page of the Savara corporate website. The abstract is published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). For more details about the ATS International Conference, please visit https://conference.thoracic.org/index.php.
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
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Savara Inc.
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